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drugset / Trial / NCT05142592

Phase1/2a Study for IPG7236 in Patients With Advanced Solid Tumors

NCT05142592 ↗

Phase 1/2 Completed 34 enrolled Nanjing Immunophage Biotech Co., Ltd
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase 1/2a first-in-human, multi-center, non-randomized, open-label study to assess the safety, tolerability, pharmacokinetics profile, and preliminary anti-tumor activity of IPG7236 administered orally as a single agent to patients with advanced solid tumors. The study will include a dose escalation phase (Phase 1) and a dose expansion phase (Phase 2a). Each part will consist of a screening period of up to 28 days, a treatment period, an end of treatment visit and a safety follow-up of approximately 30 days after the last dose. IPG7236 will be given on an empty stomach (either one hour before or two hours after a meal) twice daily (approximately every 12±1 hours) in continuous 28-day cycles.

Timeline

Start
2021-11-15
Primary completion
2026-02-08
Completion
2026-03-05

Drugs

EvaluationDrugModalityDoseRoute
Subject IPG7236 Unknown 50 mg Oral
Subject IPG7236 Unknown 100 mg Oral
Subject IPG7236 Unknown 150 mg Oral
Subject IPG7236 Unknown 200 mg Oral
Subject IPG7236 Unknown 250 mg Oral
Subject IPG7236 Unknown 300 mg Oral

Indications

No indication recorded.