A Phase Ia /Ib Dose Finding Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Preliminary Anti-Tumor Activity of ICP-189 and ICP-189 in Combination With Anti-PD-1 Monoclonal Antibody in Patients With Advanced Solid Tumors

Beijing InnoCare Pharma Tech Co., Ltd.1 site in 1 country22 target enrollmentMay 31, 2022

ConditionsPatients With Advanced Solid Tumors

InterventionsICP-189

DrugsICP-189

Overview

Phase: Phase 1
Intervention: ICP-189
Conditions: Patients With Advanced Solid Tumors
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Enrollment: 22
Locations: 1
Primary Endpoint: The incidence and severity of adverse event (AE) of ICP-189 assessed by NCI-CTCAE V5.0
Status: Not yet recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 31, 2022

End Date

January 31, 2026

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
•Patients with histologically confirmed locally advanced unresectable or metastatic solid tumors;
•At least one measurable lesion according to RECIST 1.1.

Exclusion Criteria

•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;
•Patients with unstable primary central nervous system (CNS) tumors or CNS metastases;
•Patients who have an active autoimmune disease or have had an autoimmune disease with risk of recurrence;
•Patients who have active or history of interstitial lung disease or non-infectious pneumonia;
•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.

Arms & Interventions

Phase Ia: ICP-189 Dose Escalation

Intervention: ICP-189

Outcomes

Primary Outcomes

The incidence and severity of adverse event (AE) of ICP-189 assessed by NCI-CTCAE V5.0

Time Frame: 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)

Time Frame: 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)

Time Frame: 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 Outcomes

The maximum plasma concentration observed (Cmax)(through study completion, an average of 2 years)
Time of maximum observed plasma concentration (Tmax)(through study completion, an average of 2 years)
Area under plasma concentration-time curve (AUC0-t and AUC0-∞)(through study completion, an average of 2 years)
Apparent volume of distribution (Vz/F)(through study completion, an average of 2 years)
Progression-free survival (PFS)(through study completion, an average of 2 years)
Apparent clearance (CL/F)(through study completion, an average of 2 years)
Duration of response (DoR)(through study completion, an average of 2 years)
Overall survival (OS)(through study completion, an average of 3.5 years)
Elimination half-life (t1/2)(through study completion, an average of 2 years)
The objective response rate (ORR)(through study completion, an average of 2 years)