NCT05370755Not yet recruitingPhase 1
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 enrollmentStarted: May 31, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- The incidence and severity of adverse event (AE) of ICP-189 assessed by NCI-CTCAE V5.0
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Experimental
Intervention: ICP-189 (Drug)
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)
Investigators
Study Sites (1)
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