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

NCT05370755 | Unknown Phase 1

• 1 other identifier: ICP-CL-00801
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients With Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• 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

• Elimination half-life (t1/2)

  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 clearance (CL/F)

  through study completion, an average of 2 years

Other Outcomes (1)

• Pharmacodynamics

  through study completion, an average of 2 years

Study Arms (1)

Phase Ia: ICP-189 Dose Escalation

EXPERIMENTAL

Drug: ICP-189

Interventions

ICP-189 DRUG

Administered orally

Phase Ia: ICP-189 Dose Escalation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Study Officials

• Caicun Zhou

  Shanghai Pulmonary Hospital, Shanghai, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caicun Zhou

CONTACT

+86 13301825532; caicunzhoudr@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: May 11, 2022
• Study Start: May 31, 2022
• Primary Completion: May 31, 2024
• Study Completion: January 31, 2026
• Last Updated: May 11, 2022

Record last verified: 2022-04

Locations

CN (1)