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IK-175 in Patients With Advanced or Metastatic Solid Tumors and Urothelial Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04200963
Recruitment Status : Recruiting
First Posted : December 16, 2019
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
Ikena Oncology

Brief Summary:
This study will be conducted in adult subjects diagnosed with any form of an advanced or metastatic solid tumors including urothelial carcinoma for which standard therapy is no longer effective or is intolerable. This is a phase 1, multi-center, open label study designed to assess safety and tolerability of IK-175, to determine the recommended phase 2 dose (RP2D). Disease response, pharmacokinetics (PK), pharmacodynamics, and response biomarkers will also be assessed.

Condition or disease Intervention/treatment Phase
Urothelial Carcinoma Urothelial Carcinoma Bladder Bladder Cancer Bladder Disease Solid Tumor Solid Carcinoma Solid Tumor, Adult Metastatic Cancer Advanced Solid Tumor Advanced Cancer Metastatic Bladder Cancer Metastatic Urothelial Carcinoma Locally Advanced Solid Tumor Neoplasms Neoplasm Metastasis Neoplasm Malignant Neoplasm, Bladder Urothelial Neoplasm Neoplasm, Urinary Bladder Bladder Neoplasm Bladder Urothelial Carcinoma Drug: IK-175 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Dose escalation and expansion using the revised modified Toxicity Probability Interval (mTPI-2) design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1, Open-Label, Dose-Escalation and Expansion Study of IK-175, an Oral Aryl Hydrocarbon Receptor (AHR) Inhibitor in Patients With Locally Advanced or Metastatic Solid Tumors and Urothelial Carcinoma
Actual Study Start Date : December 18, 2019
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IK-175 Dose Escalation
Approximately 5 dose escalation steps are planned during the dose escalation phase of the study.
Drug: IK-175
Subjects will be administered a single dose of IK-175 during a run-in period and then 21-day treatment cycles of IK-175
Other Name: KYN-175

Experimental: IK-175 Dose Expansion
A dose expansion phase will be performed in patients with IK-175 after completion of the dose escalation to confirm the RP2D.
Drug: IK-175
Subjects will be administered a single dose of IK-175 during a run-in period and then 21-day treatment cycles of IK-175
Other Name: KYN-175

Experimental: Single-Dose Run-In
A single dose of IK-175 will be administered to all patients prior to entering the dose escalation phase.
Drug: IK-175
Subjects will be administered a single dose of IK-175 during a run-in period and then 21-day treatment cycles of IK-175
Other Name: KYN-175




Primary Outcome Measures :
  1. Safety and tolerability of KYN-175 by characterizing type, number incidence and severity of treatment-related adverse events [ Time Frame: Up to 90 days after the end of treatment (average of 7 months) ]
    Type, number, incidence and severity of treatment related adverse events as assessed by CTCAE 5.0.

  2. Maximum Tolerated Dose (MTD) of KYN-175 and characterization of Dose Limiting Toxicities (DLTs) [ Time Frame: Approximately 4 months ]
    Type, number, and incidence of DLTs.


Secondary Outcome Measures :
  1. Pharmacokinetics of KYN-175: half-life (t1/2) [ Time Frame: Days 1 and 2 of first 2 cycles (every 21 days), followed by Day 1 of every even cycle beginning with cycle 4 (every 42 days) through end of treatment (average of 4 months) ]
    Determine KYN-175 half-life (t1/2).

  2. Pharmacokinetics of KYN-175: Maximum Serum Concentration (Cmax) [ Time Frame: Days 1 and 2 of first 2 cycles (every 21 days), followed by Day 1 of every even cycle beginning with cycle 4 (every 42 days) through end of treatment (average of 4 months) ]
    Determine KYN-175 Cmax

  3. Pharmacokinetics of KYN-175: Area Under the Curve (AUC) [ Time Frame: Days 1 and 2 of first 2 cycles (every 21 days), followed by Day 1 of every even cycle beginning with cycle 4 (every 42 days) through end of treatment (average of 4 months) ]
    Determine KYN-175 AUC

  4. Objective response rate (ORR) of KYN-175 [ Time Frame: 7 months ]
    Preliminary antitumor activity per RECIST 1.1 and assessment per immune Response Evaluation Criteria Solid Tumors (iRECIST) for subjects with urothelial carcinoma.

  5. Progression-free survival (PFS) of KYN-175 [ Time Frame: 7 months ]
    Preliminary antitumor activity per RECIST 1.1and assessment per immune Response Evaluation Criteria Solid Tumors (iRECIST) for subjects with urothelial carcinoma.

  6. Duration of treatment (DOT) of KYN-175 [ Time Frame: 7 months ]
    Preliminary antitumor activity per RECIST 1.1 and assessment per immune Response Evaluation Criteria Solid Tumors (iRECIST) for subjects with urothelial carcinoma.

  7. Duration of response (DOR) of KYN-175 [ Time Frame: 7 months ]
    Preliminary antitumor activity per RECIST 1.1 and assessment per immune Response Evaluation Criteria Solid Tumors (iRECIST) for subjects with urothelial carcinoma.

  8. Disease control rate (DCR) of KYN-175 [ Time Frame: 7 months ]
    Preliminary antitumor activity per RECIST 1.1 and assessment per immune Response Evaluation Criteria Solid Tumors (iRECIST) for subjects with urothelial carcinoma.

  9. Pharmacodynamic immune effects of KYN-175 on tumor-infiltrating cytotoxic T cells [ Time Frame: Prior to Cycle 1 Day 1, and anytime between the end of Cycle 1 and end of Cycle 2. Each cycle is 21 days. ]
    Characterization of tumor-infiltrating cytotoxic T cells in tumor biopsies collected before and during KYN-175 treatment



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Male and female adult patients 18 years of age or older on day of signing informed consent.
  • Patients with confirmed solid tumors who have locally recurrent or metastatic disease that has progressed on or following all standard of care therapies or who is not a candidate for standard treatment.
  • For patients with urothelial carcinoma, patients must have confirmation of urothelial carcinoma and have locally recurrent or metastatic disease that has progressed on or following all standard of care therapies, or who is not a candidate for standard treatment.
  • Accessible tumor that can be safely accessed for multiple core biopsies and patient is willing to provide tissue from newly obtain biopsies before and during treatment.
  • Have measurable disease.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Adequate organ function.
  • Highly effective birth control.

Exclusion Criteria:

  • Clinically unstable central nervous system (CNS) tumors or brain metastasis
  • Patients who have not recovered to ≤ Grade 1 or baseline from all adverse events (AEs) due to previous therapies
  • Any condition requiring continuous systemic treatment with either corticosteroids or other immunosuppressive medications within 2 weeks prior to first dose of study treatment.
  • Any other concurrent antineoplastic treatment except for allowed local radiation of lesions for palliation.
  • Uncontrolled or life-threatening symptomatic concomitant disease.
  • Patients that have undergone a major surgery within 3 weeks of starting trial treatment or has inadequate healing or recovery from complications of surgery prior to starting trial treatment.
  • Prior radiotherapy within 2 weeks of start of study treatment.
  • Prior AHR inhibitor treatment without Sponsor permission.
  • Potentially life-threatening second malignancy requiring systemic treatment within the last 3 years.
  • Recent or current significant cardiovascular disease (e.g. stroke, heart attack, heart failure, or arrhythmia).
  • Has an active infection requiring systemic therapy.
  • A woman of child-bearing potential (WOCBP) who has a positive pregnancy test or is breastfeeding prior to treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04200963


Contacts
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Contact: Marissa Timothy, MS 6033618939 mtimothy@ikenaoncology.com
Contact: Janine McDermott, MS 781 392 5556 jmcdermott@ikenaoncology.com

Locations
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United States, Michigan
START Midwest Recruiting
Grand Rapids, Michigan, United States, 49546
Contact: Nehal Lakhani    616-954-5554    yvette.cole@startmidwest.com   
United States, Pennsylvania
Sydney Kimmel Cancer Center Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Babar Bashir, MD    215-955-6000    mtimothy@ikenaoncology.com   
UPMC Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Jason Luke, MD, FACP    412-647-2811    mientkiewiczk@upmc.edu   
United States, Tennessee
The Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Meredith A McKean, MD    615-329-7274    Diana.CatalanNavarro@SarahCannon.com   
Sponsors and Collaborators
Ikena Oncology
Investigators
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Study Director: Jason Sager, MD Ikena Oncology
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Responsible Party: Ikena Oncology
ClinicalTrials.gov Identifier: NCT04200963    
Other Study ID Numbers: IK175-001
KYN-175 ( Other Identifier: Ikena Oncology )
First Posted: December 16, 2019    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ikena Oncology:
IK-175
KYN-175
Immunoncology
Aryl Hydrocarbon Receptor Inhibitor
AHRi
Aryl Hydrocarbon Receptor Antagonist
Antagonist
Inhibitor
Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Neoplasm Metastasis
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Urinary Bladder Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urologic Diseases