NCT05142592

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

A Phase 1/2a, Multi-center, Non-randomized, Open-label, Dose-escalation, and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of IPG7236 Administered Orally as a Single Agent in Patients With Advanced Solid Tumors

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 196 (estimated)
• Sponsor: Nanjing Immunophage Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Safety Issues
• Tolerability
• Pharmacokinetics

Interventions

Type	Name	Description
DRUG	IPG7236	The IPG7236 drug product is supplied as oral tablet dosage form, containing two strengths: 25 mg and 100 mg, respectively, which contain IPG7236.

Timeline

• Start date: 2021-11-15
• Primary completion: 2025-09-21
• Completion: 2025-12-21
• First posted: 2021-12-02
• Last updated: 2025-09-24

Locations

7 sites across 2 countries: United States, China

Regulatory

• FDA-regulated drug study