FLX475 + Pembrolizumab for Tumors/Cancer

Recruiting at 36 trial locations

Overseen By Clinical Trial Manager

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: RAPT Therapeutics, Inc.

Disqualifiers: Autoimmune disease, Pneumonitis, Transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

323 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

William Ho, MD, PhD

Principal Investigator

RAPT Therapeutics, Inc.

Eligibility Criteria

This trial is for adults with certain advanced cancers (like lung, breast, or lymphoma) who can't be helped by standard treatments. They should be fairly active and well (ECOG 0-1), have tumors that can be measured on scans, and a tumor sample available. People with severe past reactions to immune therapies, serious lung conditions, recent organ transplants, or active autoimmune diseases aren't eligible.

Inclusion Criteria

Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

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, lymphoma, head and neck squamous cell carcinoma, cervical cancer, non-small cell lung cancer, triple-negative breast cancer

Evaluable disease at baseline (at least one measurable target lesion by imaging for expansion cohorts)

Exclusion Criteria

You have experienced severe side effects from previous immunotherapy treatments that caused you to stop the treatment.

You have a history of lung diseases like pulmonary fibrosis or pneumonitis, or you currently have symptoms of lung inflammation.

You had a stem cell or organ transplant from someone else within the past 5 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Subjects are enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy or in combination with pembrolizumab

Varies

Cohort Expansion

Subjects are enrolled in parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• FLX475
• Pembrolizumab

Trial Overview The study tests FLX475 alone and combined with pembrolizumab in two parts: first finding the right dose of FLX475 (dose escalation), then giving it to more people at this dose to see how well it works and how safe it is (cohort expansion).

Participant Groups

Group I: Part 2b: Combination Expansion Cohorts Experimental Treatment 2 Interventions

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.

Group II: Part 2a: Monotherapy Expansion Cohorts Experimental Treatment 1 Intervention

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.

Group III: Part 1b: Combination Dose Escalation Experimental Treatment 2 Interventions

Eligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 in combination with pembrolizumab.

Group IV: Part 1a: Monotherapy Dose Escalation Experimental Treatment 1 Intervention

Eligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy.

Who Is Running the Clinical Trial?

RAPT Therapeutics, Inc.

Lead Sponsor

Trials

7

Recruited

800+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University