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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Patients With Advanced Solid Tumors
• Intervention / Treatment: Drug: ICP-189

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200433
      • Shanghai Pulmonary Hospital
      • Contact: Caicun Zhou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase Ia: ICP-189 Dose Escalation	Drug: ICP-189; Administered orally

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacodynamics	On-treatment versus baseline comparison of PD biomarkers e.g., phosphorylated form of extracellular signal-regulated kinase (pERK), dual specificity phosphatase 6 (DUSP6).	through study completion, an average of 2 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): May 31, 2022
• Primary Completion (Anticipated): May 31, 2024
• Study Completion (Anticipated): January 31, 2026

Study Registration Dates

• First Submitted: April 22, 2022
• First Submitted That Met QC Criteria: May 8, 2022
• First Posted (Actual): May 11, 2022

Study Record Updates

• Last Update Posted (Actual): May 11, 2022
• Last Update Submitted That Met QC Criteria: May 8, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: ICP-CL-00801

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No