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

Status
Active
Cancer Type
Breast Cancer
Cervical Cancer
Esophogeal Cancer
Head and Neck Cancer
Hodgkin Lymphoma
Lung Cancer
Lymphoma
Stomach/ Gastric Cancer
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03674567
Protocol IDs
FLX475-02 (primary)
NCI-2019-00102
Study Sponsor
RAPT Therapeutics, Inc.

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.

Eligibility

  1. Documented advanced or metastatic cancer ineligible for standard therapies with one of the following histologies
  2. 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
  3. Dose Expansion: nasopharyngeal carcinoma, lymphoma, head and neck squamous cell carcinoma, cervical cancer, non-small cell lung cancer, triple-negative breast cancer
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  5. Evaluable disease at baseline (at least one measurable target lesion by imaging for expansion cohorts)
  6. Tumor available for biopsy

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.