Study BT8009-100 in Subjects With Nectin-4 Expressing Advanced Solid Tumor Malignancies

• ClinicalTrials.gov Identifier: NCT04561362
• Recruitment Status: Recruiting
• First Posted: September 23, 2020
• Last Update Posted: November 28, 2022
• Sponsor: BicycleTx Limited
• Information provided by (Responsible Party): BicycleTx Limited

Study Description

Brief Summary:

This clinical trial is evaluating a drug called BT8009 alone and in combination with pembrolizumab in participants with advanced solid tumors associated with Nectin-4 expression or in participants with advanced solid tumor malignancies having renal insufficiency.

The main goals of this study are to:

• Find the recommended dose of BT8009 that can be given safely to participants alone and in combination with pembrolizumab
• Learn more about the side effects and effectiveness of BT8009 alone and in combination with pembrolizumab
• Learn more about BT8009 alone and in combination with pembrolizumab
• Learn more about BT8009 alone in patients with renal insufficiency

Condition or disease	Intervention/treatment	Phase
Advanced Solid Tumor; Urinary Bladder Neoplasm; Triple Negative Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Ovarian Neoplasm	Drug: BT8009; Drug: Pembrolizumab	Phase 1; Phase 2

Detailed Description:

BT8009 consists of a bicyclic peptide (Bicycle®) which binds selectively to Nectin-4 covalently attached to a spacer and a val-cit cleavable linker attached to a cytotoxin (MMAE).

This study is a Phase I/II, multicenter, first-in-human, open-label dose-escalation study of BT8009 given as a single agent in 3 different dosing schedules- weekly (28 day cycle), biweekly (28 day cycle) , dosing on day 1 and day 8 of a 3-weekly cycle and in combination with pembrolizumab. There are three parts to this study. Part A is a dose escalation in patients with select advanced solid tumors primarily designed to evaluate safety and tolerability of BT8009 as monotherapy or in combination with pembrolizumab and to determine a recommended Phase II dose (RP2D). Following a selection of an RP2D, part B, a dose expansion portion, will be initiated with the primary objective of clinical activity of BT8009 as a monotherapy or in combination with pembrolizumab in patients with select advanced solid tumors. Part C will evaluate safety and tolerability of RP2D in patients with renal insufficiency.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 329 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients With Nectin-4 Expressing Advanced Malignancies
• Actual Study Start Date: July 17, 2020
• Estimated Primary Completion Date: December 2025
• Estimated Study Completion Date: December 2025

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cohort A-1 -BT8009 Monotherapy Dose Escalation; Participants will receive increasing doses of BT8009. It is expected that approximately 60 participants will participate in this dose escalation arm.	Drug: BT8009; Participants in Cohorts A-1, Cohorts B-1- B-6 will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) or biweekly (Days 1 and 15) on a 28-day cycle or on Days 1 and 8 of a 21-day cycle. Participants in Cohorts A-2 and B-7 will receive a 60-minute IV infusion of BT8009 on Days 1 and 8 of a 21-day cycle. Participants in Cohort C will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) on a 28-day cycle.
Experimental: Cohort A-2 -BT8009 in Combination with Pembrolizumab Dose De-Escalation; Participants will receive BT8009 and a standard dose of pembrolizumab. It is expected that up to 15 participants will participate in this dose de-escalation arm.	Drug: BT8009; Participants in Cohorts A-1, Cohorts B-1- B-6 will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) or biweekly (Days 1 and 15) on a 28-day cycle or on Days 1 and 8 of a 21-day cycle. Participants in Cohorts A-2 and B-7 will receive a 60-minute IV infusion of BT8009 on Days 1 and 8 of a 21-day cycle. Participants in Cohort C will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) on a 28-day cycle.; Drug: Pembrolizumab; Participants in Cohorts A-2 and B-7 will receive 200 mg IV over 30-minute infusion of pembrolizumab on Day 1 of each 21-day cycle.; Other Name: Keytruda
Experimental: Cohort B-1 - BT8009 Monotherapy Dose Expansion; Participants with urothelial cancer and previously exposed to enfortumab vedotin (EV) will receive a selected dose of BT8009. Up to 43 participants could be enrolled in this dose expansion cohort.	Drug: BT8009; Participants in Cohorts A-1, Cohorts B-1- B-6 will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) or biweekly (Days 1 and 15) on a 28-day cycle or on Days 1 and 8 of a 21-day cycle. Participants in Cohorts A-2 and B-7 will receive a 60-minute IV infusion of BT8009 on Days 1 and 8 of a 21-day cycle. Participants in Cohort C will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) on a 28-day cycle.
Experimental: Cohort B-2- BT8009 Monotherapy Dose Expansion; Participants with urothelial cancer and not previously exposed to enfortumab vedotin (EV) will receive a selected dose of BT8009 on day 1 and day 8 of a 3-weekly cycle. Up to 43 participants could be enrolled in this dose expansion cohort.	Drug: BT8009; Participants in Cohorts A-1, Cohorts B-1- B-6 will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) or biweekly (Days 1 and 15) on a 28-day cycle or on Days 1 and 8 of a 21-day cycle. Participants in Cohorts A-2 and B-7 will receive a 60-minute IV infusion of BT8009 on Days 1 and 8 of a 21-day cycle. Participants in Cohort C will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) on a 28-day cycle.
Experimental: Cohort B-3- BT8009 Monotherapy Dose Expansion; Participants with urothelial cancer and not previously exposed to enfortumab vedotin (EV) will receive a weekly selected dose of BT8009. Up to 43 participants could be enrolled in this dose expansion cohort.	Drug: BT8009; Participants in Cohorts A-1, Cohorts B-1- B-6 will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) or biweekly (Days 1 and 15) on a 28-day cycle or on Days 1 and 8 of a 21-day cycle. Participants in Cohorts A-2 and B-7 will receive a 60-minute IV infusion of BT8009 on Days 1 and 8 of a 21-day cycle. Participants in Cohort C will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) on a 28-day cycle.
Experimental: Cohort B-4- BT8009 Monotherapy Dose Expansion; Participants with ovarian cancer will receive a selected dose of BT8009. Up to 29 participants could be enrolled in this dose expansion cohort.	Drug: BT8009; Participants in Cohorts A-1, Cohorts B-1- B-6 will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) or biweekly (Days 1 and 15) on a 28-day cycle or on Days 1 and 8 of a 21-day cycle. Participants in Cohorts A-2 and B-7 will receive a 60-minute IV infusion of BT8009 on Days 1 and 8 of a 21-day cycle. Participants in Cohort C will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) on a 28-day cycle.
Experimental: Cohort B-5- BT8009 Monotherapy Dose Expansion; Participants with triple-negative breast cancer (TNBC) will receive a selected dose of BT8009. Up to 29 participants could be enrolled in this dose expansion cohort.	Drug: BT8009; Participants in Cohorts A-1, Cohorts B-1- B-6 will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) or biweekly (Days 1 and 15) on a 28-day cycle or on Days 1 and 8 of a 21-day cycle. Participants in Cohorts A-2 and B-7 will receive a 60-minute IV infusion of BT8009 on Days 1 and 8 of a 21-day cycle. Participants in Cohort C will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) on a 28-day cycle.
Experimental: Cohort B-6- BT8009 Monotherapy Dose Expansion; Participants with non-small cell lung cancer (NSCLC) will receive a selected dose of BT8009. Up to 29 participants could be enrolled in this dose expansion cohort.	Drug: BT8009; Participants in Cohorts A-1, Cohorts B-1- B-6 will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) or biweekly (Days 1 and 15) on a 28-day cycle or on Days 1 and 8 of a 21-day cycle. Participants in Cohorts A-2 and B-7 will receive a 60-minute IV infusion of BT8009 on Days 1 and 8 of a 21-day cycle. Participants in Cohort C will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) on a 28-day cycle.
Experimental: Cohort B-7- BT8009 in Combination with Pembrolizumab Dose Expansion; Participants with first-line, cisplatin-ineligible, metastatic urothelial cancer will receive a selected dose of BT8009 and standard dose of pembrolizumab. Approximately 20 participants could be enrolled in this dose expansion cohort.	Drug: BT8009; Participants in Cohorts A-1, Cohorts B-1- B-6 will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) or biweekly (Days 1 and 15) on a 28-day cycle or on Days 1 and 8 of a 21-day cycle. Participants in Cohorts A-2 and B-7 will receive a 60-minute IV infusion of BT8009 on Days 1 and 8 of a 21-day cycle. Participants in Cohort C will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) on a 28-day cycle.; Drug: Pembrolizumab; Participants in Cohorts A-2 and B-7 will receive 200 mg IV over 30-minute infusion of pembrolizumab on Day 1 of each 21-day cycle.; Other Name: Keytruda
Experimental: Cohort C - Renal Insufficiency BT8009 Monotherapy Dose Expansion; Participants with renal insufficiency will receive a selected dose of BT8009. Approximately 18 participants could be enrolled in this dose expansion cohort.	Drug: BT8009; Participants in Cohorts A-1, Cohorts B-1- B-6 will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) or biweekly (Days 1 and 15) on a 28-day cycle or on Days 1 and 8 of a 21-day cycle. Participants in Cohorts A-2 and B-7 will receive a 60-minute IV infusion of BT8009 on Days 1 and 8 of a 21-day cycle. Participants in Cohort C will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) on a 28-day cycle.

Outcome Measures

Primary Outcome Measures :

1. Cohorts A-1, A-2 and C: Number of participants with treatment emergent adverse events receiving BT8009 alone and in combination with pembrolizumab to assess safety and tolerability [ Time Frame: From cycle 1 day 1 until at least 30 days after the end of treatment (each cycle is 21 or 28 days depending on the assigned dosing schedule) ]
   Safety reported as incidence of treatment-emergent adverse events using CTCAE v5.0 criteria.
2. Cohorts A-1 and A-2 (escalations): Number of participants with dose limiting toxicities on BT8009 alone and in combination with pembrolizumab. [ Time Frame: 28 days (for cycles that are either 21 or 28 days in length depending on dosing schedule assigned). ]
   Number of patients who experience dose limiting toxicities BT8009 when given as a monotherapy and in combination with pembrolizumab.
3. Cohorts B-1, B-2, and B-3 (expansions): Objective response rate (ORR) to assess the clinical activity of BT8009 as a monotherapy in patients with urothelial cancer using RECIST 1.1. [ Time Frame: Every 8 weeks for 12 months then every 12 weeks thereafter until disease progression or, death, or up to three years ]
   Proportion of participants with urothelial cancer with confirmed complete response or partial response to BT8009 as a monotherapy according to RECIST 1.1 criteria.
4. Cohorts B-4, B-5, and B-6 (expansions): Objective response rate (ORR) to assess the clinical activity of BT8009 as a monotherapy in patients with selected solid tumor indications associated with Nectin-4 expression using RECIST 1.1. [ Time Frame: Every 8 weeks for 12 months then every 12 weeks thereafter until disease progression or, death, or up to three years ]
   Proportion of participants with selected solid tumor indications associated with Nectin-4 expression with confirmed complete response or partial response to BT8009 monotherapy according to RECIST 1.1 criteria.
5. Cohort B-7 (expansion): Objective response rate (ORR) to assess the clinical activity of BT8009 in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma in combination with pembrolizumab using RECIST 1.1. [ Time Frame: Every 8 weeks for 12 months then every 12 weeks thereafter until disease progression or, death, or up to three years ]
   Proportion of participants with cisplatin-ineligible, locally advanced or metastatic urothelial carcinoma with confirmed complete response or partial response to BT8009 in combination with pembrolizumab according to RECIST 1.1 criteria.

Secondary Outcome Measures :

1. Cohorts B1- B7: Number of participants with treatment emergent adverse events receiving BT8009 alone and in combination with pembrolizumab to assess safety and tolerability. [ Time Frame: From cycle 1 day 1 until at least 30 days after the end of treatment (each cycle is 21 or 28 days depending on the assigned dosing schedule) ]
   Number of participants with advanced solid tumor malignancies associated with Nectin-4 expression receiving BT8009 alone or in combination with pembrolizumab who experience treatment-emergent adverse events using CTCAE v5.0 criteria.
2. Cohorts B1- B7: Duration of Response time to assess preliminary anti-tumor activity of BT8009 as a monotherapy and in combination with pembrolizumab [ Time Frame: Every 8 weeks for 12 months then every 12 weeks thereafter until disease progression or, death, or up to three years ]
   Duration of objective response (complete or partial response) by RECIST 1.1 in participants receiving BT8009 treatment alone and in combination with pembrolizumab
3. Cohorts B-1- B-7: Clinical benefit rate to assess the clinical activity of BT8009 as a monotherapy and in combination with pembrolizumab [ Time Frame: Every 8 weeks for 12 months then every 12 weeks thereafter until disease progression or death or up to 3 years ]
   Proportion of participants who have complete response (CR), partial response (PR), or stable disease (SD) for at least 16 weeks according to RECIST Version 1.1 criteria.
4. Cohorts B-1- B-7: Progression-free survival time to assess the clinical activity of BT8009 as a monotherapy and in combination with pembrolizumab [ Time Frame: Every 8 weeks for the first 12 months then every 12 weeks until disease progression or death for up to three years ]
   The time from the first day of study drug administration (Day 1) to disease progression according to RECIST 1.1 criteria in participants receiving BT8009 treatment alone and in combination with pembrolizumab.
5. Cohorts B-1-and B-7: Overall survival time to assess the clinical activity of BT8009 as a monotherapy and in combination with pembrolizumab using RECIST 1.1 [ Time Frame: Every 8 weeks for the first 12 months then every 12 weeks until death, then every 3 months for up to 1 year after last patient accrued ]
   The time from start of study drug administration (Day 1) until death due to any cause in participants receiving BT8009 treatment alone and in combination with pembrolizumab.
6. Cohorts B-4, B-5, and B-6: Objective response rate by Nectin-4 status of BT8009 as a monotherapy in patients with selected solid tumor using RECIST 1.1. [ Time Frame: Every 8 weeks for the first 12 months then every 12 weeks until disease progression or death for up to three years ]
   Proportion of participants with confirmed complete response or partial response to BT8009 monotherapy according to RECIST 1.1 criteria categorized by Nectin-4 expression status.
7. Part A-1 and A-2 and C: Objective response rate to assess preliminary anti-tumor activity of BT8009 as a monotherapy and in combination with pembrolizumab [ Time Frame: Every 8 weeks for the first 12 months then every 12 weeks until disease progression or death or up to three years ]
   Proportion of participants with advanced solid tumor malignancies associated with Nectin-4 expression or advanced solid tumor malignancies having renal insufficiency with confirmed complete response or partial response according to RECIST 1.1 criteria
8. Cohorts A-1 and A-2 and C: Duration of Response time to assess preliminary anti-tumor activity of BT8009 as a monotherapy and in combination with pembrolizumab [ Time Frame: Every 8 weeks for the first 12 months then every 12 weeks until disease progression or death or up to three years ]
   Duration of objective response (complete or partial response) by RECIST 1.1 in participants with advanced solid tumor malignancies associated with Nectin-4 expression or advanced solid tumor malignancies having renal insufficiency receiving BT8009 treatment alone and in combination with pembrolizumab
9. Cohorts A-1 and A-2 and C: Clinical benefit rate to assess preliminary anti-tumor activity of BT8009 as a monotherapy and in combination with pembrolizumab [ Time Frame: Every 8 weeks for the first 12 months then every 12 weeks until disease progression for up to 3 years ]
   Proportion of participants with advanced solid tumor malignancies associated with Nectin-4 expression or advanced solid tumor malignancies having renal insufficiency who have complete response (CR), partial response (PR) or stable disease (SD) for at least 16 weeks according to the RECIST Version 1.1 criteria.
10. Cohorts A-1 and A-2 and C: Progression-free survival time (months) to assess preliminary anti-tumor activity of BT8009 as a monotherapy and in combination with pembrolizumab [ Time Frame: Every 8 weeks for the first 12 months then every 12 weeks until disease progression or death for up to three years ]
    The time from start of study drug administration until disease progression according to RECIST 1.1 in participants with advanced solid tumor malignancies associated with Nectin-4 expression or advanced solid tumor malignancies having renal insufficiency receiving BT8009 treatment alone and in combination with pembrolizumab
11. Cohorts A-1 and A-2 and C: Overall survival time (months) to assess preliminary anti-tumor activity of BT8009 as a monotherapy and in combination with pembrolizumab [ Time Frame: Every 8 weeks for the first 12 months then every 12 weeks until disease progression, then every 3 months for up to 1 year after last patient is accrued ]
    The time from start of study drug administration until death due to any cause in participants with advanced solid tumor malignancies associated with Nectin-4 expression or advanced solid tumor malignancies having renal insufficiency receiving BT8009 treatment alone and in combination with pembrolizumab.
12. All cohorts: Maximum plasma concentration (Cmax) of BT8009 and monomethyl auristatin E (MMAE) when given as monotherapy and in combination with pembrolizumab [ Time Frame: From Cycle 1 Day 1 through end of treatment or for up to 1 year (Cycles are 21 days or 28 days depending on the assigned dosing schedule) ]
    Plasma concentrations of BT8009 and MMAE from all participants taking BT8009 alone and in combination with pembrolizumab
13. All cohorts: Minimum plasma concentration (Cmin) of BT8009 and monomethyl auristatin E (MMAE) when given as monotherapy and in combination with pembrolizumab [ Time Frame: From Cycle 1 Day 1 through end of treatment or for up to 1 year (Cycles are 21 days or 28 days depending on the assigned dosing schedule) ]
    Plasma concentrations of BT8009 and MMAE from all participants taking BT8009 alone and in combination with pembrolizumab
14. All cohorts: Area under the plasma concentration-time curve (AUC) of BT8009 and monomethyl auristatin E (MMAE) when given as monotherapy and in combination with pembrolizumab [ Time Frame: From Cycle 1 Day 1 through end of treatment or for up to 1 year (Cycles are 21 days or 28 days depending on the assigned dosing schedule) ]
15. All cohorts: Elimination half-life (t1/2) of BT8009 and monomethyl auristatin E (MMAE) when given as monotherapy and in combination with pembrolizumab [ Time Frame: From Cycle 1 Day 1 through end of treatment or for up to 1 year (Cycles are 21 days or 28 days depending on the assigned dosing schedule) ]
16. All cohorts: Number of participants positive for anti-drug antibodies (ADA) to determine incidence of ADA [ Time Frame: From Cycle 1 Day 1 through end of treatment or for up to 1 year (Cycles are 21 days or 28 days depending on the assigned dosing schedule) ]
    Number of participants positive for anti-drug antibodies (ADA) from all participants receiving BT8009 alone and in combination with pembrolizumab

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Key Inclusion Criteria

• Life expectancy ≥12 weeks.
• Patients must have measurable disease per RECIST 1.1.

• Part A-1 cohorts:

  • Must have exhausted all standard treatment options, including appropriate targeted therapies; or patients for which no standard therapy is considered appropriate
  • Patients with advanced, histologically confirmed urothelial (transitional cell) carcinoma that recurred after or has been refractory to prior therapy (fresh tumor biopsy or an archived sample must be submitted); or
  • Patients with advanced, histologically confirmed pancreatic, breast, non-small-cell lung cancer (NSCLC), gastric, esophageal, head and neck, or ovarian tumors that recurred after or has been refractory to prior therapy (fresh tumor biopsy or an archived sample testing for Nectin-4 expression).

• Part A-2:

  • Must have exhausted all standard treatment options, including appropriate targeted therapies; or patients for which no standard therapy is considered appropriate
  • Patients with advanced, histologically confirmed urothelial (transitional cell) carcinoma that recurred after or has been refractory to prior therapy
• Cohort B-1: Histologically documented urothelial carcinoma, previously treated with enfortumab vedotin (EV). Patients with resectable, locally advanced urothelial carcinoma are ineligible. Must have had progression or recurrence of urothelial cancer during or following receipt of most recent therapy.
• Cohort B-2 and B-3: Histologically documented urothelial carcinoma, not previously treated with enfortumab vedotin (EV). Patients with resectable, locally advanced urothelial carcinoma are ineligible. Must have had progression or recurrence of urothelial cancer during or following receipt of most recent therapy.
• Cohort B-4: Histologically confirmed non-mucinous epithelial ovarian, fallopian tube, or primary peritoneal cancer that is Stage III or IV according to the International Federation of Gynecology and Obstetrics (FIGO) or tumor, node and metastasis staging criteria that recurred after or has been refractory to prior therapy.
• Cohort B-5: Breast cancers that have been confirmed negative for estrogen receptor (ER) and progesterone receptor (PR) and negative for human epidermal growth factor receptor 2 (HER2) (i.e., triple-negative) that have recurred after or has been refractory to prior therapy.
• Cohort B-6: Histologically confirmed non-small cell lung cancer (NSCLC) with no actionable mutations, such as Epidermal Growth Factor Receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) fusion oncogene, or ROS1 that recurred after or has been refractory to prior therapy.
• Cohort B-7: Locally advanced or metastatic, histologically confirmed urothelial (transitional cell) carcinoma, ineligible for cisplatin, no prior systemic anticancer treatment for advanced urothelial carcinoma.
• Cohort C renal insufficiency cohort: Patients with histologically documented urothelial carcinoma that recurred after or has been refractory to prior therapy.

Key Exclusion Criteria (all patients):

• Clinically relevant troponin elevation
• Uncontrolled diabetes
• Uncontrolled, symptomatic brain metastases
• Patients with uncontrolled hypertension
• History of another malignancy within 3 years before first dose of BT8009 or residual disease from a previously diagnosed malignancy (with some exceptions).
• Active systemic infection requiring therapy, or fever within the last 14 days prior to first dose of BT8009.
• Prior Stevens-Johnson syndrome/toxic epidermal necrolysis on any MMAE-conjugated drug

• Parts A-2 and B-7 Pembrolizumab Combination Cohorts:

  • Prior organ transplant (including allogeneic)
  • Diagnosis of clinically relevant immunodeficiency
  • History of interstitial lung disease
• Parts B-2 and B-3: Prior treatment with enfortumab vedotin

Other protocol-defined Inclusion/Exclusion criteria may apply

Contacts and Locations

Contacts

Contact: Bicycle Tx Limited; 617-945-8155; clinicalstudies@bicycletx.com

Locations

United States, Colorado

Sarah Cannon Research Institute at HealthONE; Recruiting

Denver, Colorado, United States, 80218

Principal Investigator: Gerald Falchook, MD

United States, Florida

Ocala Oncology Center; Recruiting

Ocala, Florida, United States, 34474

Principal Investigator: Rama Balaraman, MD

United States, Indiana

Horizon Oncology Research; Recruiting

Lafayette, Indiana, United States, 47905

Principal Investigator: Costantine Albany, MD

United States, Kentucky

Norton Cancer Institute, Downtown; Recruiting

Louisville, Kentucky, United States, 40202

Principal Investigator: Jaspreet Singh Grewal, MD, PhD, MPH

United States, Nevada

Comprehensive Cancer Centers of Nevada; Withdrawn

Las Vegas, Nevada, United States, 89169

United States, Ohio

University Hospitals Cleveland Medical Center; Recruiting

Cleveland, Ohio, United States, 44106

Principal Investigator: Jason Robert Brown, MD, PhD

United States, Pennsylvania

Thomas Jefferson University, Sidney Kimmel Cancer Center; Recruiting

Philadelphia, Pennsylvania, United States, 19107

Principal Investigator: Sarah W. Gordon, DO

United States, Tennessee

Tennessee Oncology, PLLC; Recruiting

Nashville, Tennessee, United States, 37203

Contact: Meredith McKean, MD, MPH

United States, Texas

The University of Texas MD Anderson Cancer Center; Recruiting

Houston, Texas, United States, 77030

Principal Investigator: Jordi Rodon Ahnert, MD, PhD

Canada, Alberta

Cross Cancer Institute; Recruiting

Edmonton, Alberta, Canada, T6G 1Z2

Principal Investigator: Quincy Siu Chung Chu, MD

Canada, Ontario

Princess Margaret Cancer Centre; Recruiting

Toronto, Ontario, Canada, M5G IZ5

Principal Investigator: Aaron R. Hansen, MD

France

Institut Bergonie; Recruiting

Bordeaux, France, 33076

Principal Investigator: Antoine Italiano, MD, PhD

Centre Leon Berard; Recruiting

Lyon, France, 69373

Principal Investigator: Loic Verligue, MD

Institut Gustave Roussy; Recruiting

Villejuif, France, 94805

Principal Investigator: Capucine Baldini, MD

Italy

Ospedale San Raffaele; Recruiting

Milan, Italy, 20132

Principal Investigator: Andrea Necchi, MD

Spain

Vall d'Hebron Institute of Oncology; Recruiting

Barcelona, Spain, 08035

Principal Investigator: Irene Brana, MD, PhD

Hospital Clinic de Barcelona; Recruiting

Barcelona, Spain, 08036

Principal Investigator: Oscar Reig, MD

START Madrid Fundacion Jimenez Diaz; Recruiting

Madrid, Spain, 28040

Principal Investigator: Bernard Doger, MD, PhD

Next Oncology - Hospital Quironsalud Madrid; Recruiting

Madrid, Spain, 28223

Principal Investigator: Valentina Boni, MD

United Kingdom

Sarah Cannon Research Institute UK; Recruiting

London, United Kingdom, W1G 6AD

Principal Investigator: Hendrik-Tobias Arkenau, MD

The Christie NHS Foundation Trust; Recruiting

Manchester, United Kingdom, M20 4BX

Principal Investigator: Louise Carter, MBBS, PhD

Sponsors and Collaborators

BicycleTx Limited

Investigators

• Study Chair: Meredith McKean, MD, MPH; Tennessee Oncology, PLLC

More Information

• Responsible Party: BicycleTx Limited
• ClinicalTrials.gov Identifier: NCT04561362
• Other Study ID Numbers: BT8009-100
• First Posted: September 23, 2020
• Last Update Posted: November 28, 2022
• Last Verified: November 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by BicycleTx Limited:

Nectin-4; Solid tumor; Transitional urothelial carcinoma; Renal insufficiency

Additional relevant MeSH terms:

Neoplasms; Breast Neoplasms; Carcinoma, Non-Small-Cell Lung; Ovarian Neoplasms; Urinary Bladder Neoplasms; Triple Negative Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Urologic Neoplasms; Urinary Bladder Diseases