NCT07508761

IPG7236 Combined With Toripalimab in Participants With Advanced Solid Tumors

A Phase I/II Multicenter, Non-randomized, Open-label, Dose Escalation and Expansion Study of IPG7236 Combined With Toripalimab Treatment of Advanced Solid Tumors in Adult Patients to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Nanjing Immunophage Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 1/2 Study for IPG7236 Combined With Toripalimab in Participants With Advanced Solid Tumors

Detailed description

This is a phase 1/2, multicenter, non-randomized, open-label, dose-escalation and dose-expansion study. Part A (dose escalation) will adopt a standard "3+3" design with two cohorts (IPG7236 500 mg BID + Toripalimab 240 mg Q3W; IPG7236 800 mg BID + Toripalimab 240 mg Q3W) to determine the MTD and/or RP2D. Part B (dose expansion) will enroll approximately 40 CCR8-positive advanced solid tumor patients to further evaluate safety,tolerability and preliminary antitumor activity. The transition from Part A to Part B will be triggered after confirmation of RP2D based on safety, tolerability, PK and preliminary efficacy data.

Conditions

• Advanced Solid Tumor

Interventions

Type	Name	Description
DRUG	IPG7236	IPG7236: Part A: 500 mg BID or 800 mg BID, the dose in Part B is the RP2D confirmed in Part A, Oral (fasting: 1 hour before meal or 2 hours after meal, every 12±2 hours), Continuous daily administration, 21-day treatment cycle,Until disease progression, unacceptable toxicity, withdrawal of consent, or other reasons for withdrawal
DRUG	Toripalimab Injection	Toripalimab Injection: 240 mg , Q3W, 21-day treatment cycle, the first infusion lasts at least 60 minutes; if well tolerated, subsequent infusions can be shortened to 30 minutes.

Timeline

• Start date: 2026-05-15
• Primary completion: 2028-12-30
• Completion: 2029-07-30
• First posted: 2026-04-02
• Last updated: 2026-04-02

Locations

1 site across 1 country: China