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

  • STATUS
    Recruiting
  • End date
    Dec 1, 2022
  • participants needed
    375
  • sponsor
    RAPT Therapeutics, Inc.
Updated on 1 February 2021
Investigator
Clinical Trial Manager
Primary Contact
Prince of Wales Hospital (0.0 mi away) Contact
+30 other location
lymphoma
carcinoma
breast cancer
squamous cell carcinoma
lung cancer
metastasis
gastric cancer

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.

Details
Condition Advanced Cancer, cancer advanced
Treatment Pembrolizumab, FLX475
Clinical Study IdentifierNCT03674567
SponsorRAPT Therapeutics, Inc.
Last Modified on1 February 2021

Eligibility

Yes No Not Sure

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, 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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