A Study of ICP-189 and ICP-189 in Combination With Anti-PD-1 Monoclonal Antibody in Patients With Advanced Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2026-01-31
• Target enrollment: 0
• Participant gender: All

Summary

A Dose finding Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Preliminary Anti-Tumor Activity of ICP-189 Tablets and ICP-189 Tablets in Combination with Anti-PD-1 Monoclonal Antibody in Patients with Advanced Solid Tumors.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Criteria

Inclusion Criteria:

1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;

2. Patients with histologically confirmed locally advanced unresectable or metastatic solid tumors;

3. At least one measurable lesion according to RECIST 1.1.

Exclusion Criteria:

1. Patients who have had other cancer(s) within 5 years prior to the first dose, except for locally curable cancers that have been apparently cured;

2. Patients with unstable primary central nervous system (CNS) tumors or CNS metastases;

3. Patients who have an active autoimmune disease or have had an autoimmune disease with risk of recurrence;

4. Patients who have active or history of interstitial lung disease or non-infectious pneumonia;

5. Patients who have a history of severe allergic reaction to any component of ICP-189 tablets or anti-PD-1 antibody (> grade 3 assessed by CTCAE 5.0).

Other protocol-defined inclusion/exclusion criteria apply.