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Trial record 1 of 1 for:    NCT03674567
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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 23, 2019
Sponsor:
Information provided by (Responsible Party):
RAPT Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE September 14, 2018
First Posted Date  ICMJE September 17, 2018
Last Update Posted Date December 23, 2019
Actual Study Start Date  ICMJE September 25, 2018
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
  • 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 ]
  • 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) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Escalation and Expansion Study of FLX475 Monotherapy and in Combination With Pembrolizumab
Official Title  ICMJE Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination With Pembrolizumab in Advanced Cancer
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Cancer
Intervention  ICMJE
  • Drug: FLX475
    tablet
  • Drug: Pembrolizumab
    IV infusion
    Other Name: Keytruda
Study Arms  ICMJE
  • Experimental: Part 1a: Monotherapy Dose Escalation
    Eligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy.
    Intervention: Drug: FLX475
  • 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.
    Interventions:
    • Drug: FLX475
    • Drug: Pembrolizumab
  • 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.
    Intervention: Drug: FLX475
  • 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.
    Interventions:
    • Drug: FLX475
    • Drug: Pembrolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 14, 2018)
375
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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, metastatic triple negative breast cancer, urothelial carcinoma, gastric cancer, esophageal carcinoma, cervical 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Trial Manager 650-489-9000 clinical.trials@rapt.com
Listed Location Countries  ICMJE Australia,   Hong Kong,   Korea, Republic of,   Taiwan,   Thailand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03674567
Other Study ID Numbers  ICMJE FLX475-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party RAPT Therapeutics, Inc.
Study Sponsor  ICMJE RAPT Therapeutics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: William Ho, MD, PhD RAPT Therapeutics, Inc.
PRS Account RAPT Therapeutics, Inc.
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP