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Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab

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ClinicalTrials.gov Identifier: NCT03674567
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
FLX Bio, Inc.

Brief Summary:

This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab.

The study will be conducted in 2 parts, a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2). In Part 1 of the study, subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy or in combination with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.


Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: FLX475 Drug: Pembrolizumab Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 375 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination With Pembrolizumab in Advanced Cancer
Actual Study Start Date : September 25, 2018
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Part 1a: Monotherapy Dose Escalation
Eligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy.
Drug: FLX475
tablet

Experimental: Part 1b: Combination Dose Escalation
Eligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 in combination with pembrolizumab.
Drug: FLX475
tablet

Drug: Pembrolizumab
IV infusion
Other Name: Keytruda

Experimental: Part 2a: Monotherapy Expansion Cohorts
Eligible subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy; additional subjects in each cohort may be enrolled in Stage 2.
Drug: FLX475
tablet

Experimental: Part 2b: Combination Expansion Cohorts
Eligible subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 in combination with pembrolizumab; additional subjects in each cohort may be enrolled in Stage 2.
Drug: FLX475
tablet

Drug: Pembrolizumab
IV infusion
Other Name: Keytruda




Primary Outcome Measures :
  1. Safety and tolerability of FLX475 as a single agent and in combination with pembrolizumab measured by the incidence of adverse events, including dose-limiting toxicities and maximum tolerated dose [ Time Frame: Approximately 18 weeks ]
  2. Overall response rate in subjects treated with FLX475 as a single agent and in combination with pembrolizumab [ Time Frame: Through study completion (approximately 2 years) ]


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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:

  • Documented advanced or metastatic cancer ineligible for standard therapies with one of the following histologies

    • Dose Escalation: non-small cell lung cancer, head and neck squamous cell carcinoma, nasopharyngeal carcinoma, breast cancer, urothelial carcinoma, gastric cancer, colorectal adenocarcinoma, esophageal carcinoma, cervical cancer, ovarian cancer, classical Hodgkin lymphoma
    • Dose Expansion: nasopharyngeal carcinoma, gastric cancer, EBV+ lymphoma, head and neck squamous cell carcinoma, cervical cancer, non-small cell lung cancer, triple-negative breast cancer
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  • Evaluable disease at baseline (at least one measurable target lesion by imaging for expansion cohorts)
  • Tumor available for biopsy

Exclusion Criteria:

  • History of allergy or severe hypersensitivity to biologic agents
  • History of Grade 3-4 immune-related adverse events leading to discontinuation of prior immuno-oncology treatment
  • Active autoimmune disease or serious autoimmune disease within past 2 years requiring systemic therapy
  • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, (non-infectious) pneumonitis that required steroids, or symptoms of active pneumonitis
  • Prior allogeneic hematopoietic stem cell transplant within 5 years, or prior allogeneic organ transplant
  • Active graft-versus-host disease

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): NCT03674567


Contacts
Contact: Clinical Trial Manager 650-489-9000 clinical.trials@flxbio.com

Locations
United States, California
University of California, Los Angeles JCCC Clinical Research Unit Not yet recruiting
Los Angeles, California, United States, 90024
Contact: Ashlee Astacio    310-794-3883    AAstacio@mednet.ucla.edu   
University of California, San Diego Moores Cancer Center Not yet recruiting
San Diego, California, United States, 92093
Contact: Ashley Weaver    858-822-1962    aweaver@ucsd.edu   
United States, Connecticut
Yale Cancer Center Not yet recruiting
New Haven, Connecticut, United States, 06510
Contact: Caroline Hotchkins    203-737-5228      
United States, North Carolina
Carolina BioOncology Institute Recruiting
Huntersville, North Carolina, United States, 28078
Contact: Ashley A McClain    704-947-6599 ext 117      
Australia, Western Australia
Linear Clinical Research Limited Recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Samantha Bowyer, MD    +61 (08) 6382 5100    Samantha.Bowyer@health.wa.gov.au   
Sponsors and Collaborators
FLX Bio, Inc.
Investigators
Study Director: William Ho, MD, PhD FLX Bio

Responsible Party: FLX Bio, Inc.
ClinicalTrials.gov Identifier: NCT03674567     History of Changes
Other Study ID Numbers: FLX475-02
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018

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

Keywords provided by FLX Bio, Inc.:
Non-small Cell Lung Cancer
Head and Neck Squamous Cell Carcinoma
Breast Cancer
Urothelial Carcinoma
Gastric Cancer

Additional relevant MeSH terms:
Pembrolizumab
Antineoplastic Agents