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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-31

Study Completion Date

2026-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Patients With Advanced Solid Tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Phase Ia: ICP-189 Dose Escalation

Group Type EXPERIMENTAL

ICP-189

Intervention Type DRUG

Administered orally

Interventions

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ICP-189

Administered orally

Intervention Type DRUG

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No