NCT04383938

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Aprea Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer
• Gastric Cancer
• Non Small Cell Lung Cancer
• NSCLC
• Urothelial Carcinoma
• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	APR-246 (eprenetapopt) + Pembrolizumab	APR-246 D1-4 + Pembrolizumab D3

Timeline

• Start date: 2020-06-25
• Primary completion: 2022-04-30
• Completion: 2022-04-30
• First posted: 2020-05-12
• Last updated: 2025-05-13
• Results posted: 2025-05-13

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study