Spots Global Cancer Trial Database for Phase 1/2 Study of APR-246 in Combination With Pembrolizumab in Subjects With Solid Tumor Malignancies

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Trial Identification

Brief Title: Phase 1/2 Study of APR-246 in Combination With Pembrolizumab in Subjects With Solid Tumor Malignancies

Official Title: Study of APR-246 in Combination With Pembrolizumab in Subjects With Solid Tumor Malignancies

Study ID: NCT04383938

Conditions

Bladder Cancer

Gastric Cancer

Non Small Cell Lung Cancer

NSCLC

Urothelial Carcinoma

Advanced Solid Tumor

Interventions

APR-246 (eprenetapopt) + Pembrolizumab

Study Description

Brief Summary: A phase 1/2, open-label, study to determine the safety and preliminary efficacy of APR-246 in combination with pembrolizumab in subjects with solid tumor malignancies. The study will include a safety lead-in portion followed by a phase 2 expansion portion in specific disease groups.

Detailed Description: This is a phase 1/2, open-label, study to determine the safety and preliminary efficacy of APR-246 (eprenetapopt) in combination with pembrolizumab in subjects with solid tumor malignancies. In the safety lead-in part of study (phase 1), the safety and the recommended phase 2 dose (RP2D) of APR-246 will be investigated. In the expansion part of the study (phase 2), both safety and efficacy for the combination therapy will be investigated in the 3 cohorts.