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

Phase 1

Not yet recruiting

• Conditions: Patients With Advanced Solid Tumors
• Interventions: Drug: ICP-189

• Registration Number: NCT05370755
• Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-22
• Study First Submitted QC: 2022-05-08
• Last Update Submitted: 2022-05-08
• Study First Posted: 2022-05-11
• Last Update Posted: 2022-05-11
• Study Start: 2022-05-31
• Primary Completion: 2024-05-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase Ia: ICP-189 Dose Escalation	ICP-189	-

Primary Outcome Measures

Name	Time	Method
The incidence and severity of adverse event (AE) of ICP-189 assessed by NCI-CTCAE V5.0	through study completion, an average of 2 years	To assess the safety and tolerability of ICP-189 in patients with advanced solid tumors.
Dose-Limiting Toxicities (DLTs)	through study completion, an average of 2 years	Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs).
Recommended Phase 2 Dose (RP2D) and/or maximum tolerated dose (MTD)	through study completion, an average of 2 years	To preliminarily determine the PR2D and the MTD of ICP-189 in patients with advanced solid tumors

Secondary Outcome Measures

Name	Time	Method
The maximum plasma concentration observed (Cmax)	through study completion, an average of 2 years	To evaluate the pharmacokinetic (PK) characteristics of ICP-189 in patients with solid tumors.
Time of maximum observed plasma concentration (Tmax)	through study completion, an average of 2 years	To evaluate the pharmacokinetic (PK) characteristics of ICP-189 in patients with solid tumors.
Area under plasma concentration-time curve (AUC0-t and AUC0-∞)	through study completion, an average of 2 years	To evaluate the pharmacokinetic (PK) characteristics of ICP-189 in patients with solid tumors.
Apparent volume of distribution (Vz/F)	through study completion, an average of 2 years	To evaluate the pharmacokinetic (PK) characteristics of ICP-189 in patients with solid tumors.
Progression-free survival (PFS)	through study completion, an average of 2 years	To evaluate the preliminary anti-tumor activity of ICP-189.
Apparent clearance (CL/F)	through study completion, an average of 2 years	To evaluate the pharmacokinetic (PK) characteristics of ICP-189 in patients with solid tumors.
Duration of response (DoR)	through study completion, an average of 2 years	To evaluate the preliminary anti-tumor activity of ICP-189.
Overall survival (OS)	through study completion, an average of 3.5 years	To evaluate the preliminary anti-tumor activity of ICP-189.
Elimination half-life (t1/2)	through study completion, an average of 2 years	To evaluate the pharmacokinetic (PK) characteristics of ICP-189 in patients with solid tumors.
The objective response rate (ORR)	through study completion, an average of 2 years	To evaluate the preliminary anti-tumor activity of ICP-189.

Trial Locations

Locations (1)

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, Shanghai, China