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Phase 1 / 2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination With Pembrolizumab in Advanced Cancer

Status
Active
Cancer Type
Breast Cancer
Cervical Cancer
Head and Neck Cancer
Lung Cancer
Lymphoma
Ovarian Cancer
Skin Cancer (Non-Melanoma)
Stomach/ Gastric Cancer
Unknown Primary
Trial Phase
Phase I
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCD ID
NCT03674567
Protocol IDs
FLX475-02 (primary)
NCI-2019-00102
Study Sponsor
FLX Bio, 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.
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