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

InnoCare Pharma

Status and phase: Not yet enrolling; Phase 1

Conditions: Patients With Advanced Solid Tumors

Treatments: Drug: ICP-189

Study type: Interventional

Funder types: Industry

Identifiers

NCT05370755

ICP-CL-00801

Details and patient eligibility

About

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.

Enrollment: 22 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Phase Ia: ICP-189 Dose Escalation

Experimental group

Treatment:

Drug: ICP-189