A Clinical Trial of ICP-192 in Treated Patients With Advanced Solid Tumors With FGF/FGFR Gene Alterations

Study Overview
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Brief Summary
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This is a phase II clinical trial in treated patients with advanced solid tumors with FGF/FGFR gene alterations. The purpose of this study is to evaluate the efficacy and safety of ICP-192.

Official Title
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A Phase II Clinical Trial to Evaluate the Efficacy and Safety of ICP-192 in Treated Patients With Advanced Solid Tumors With FGF/FGFR Gene Alterations

Conditions
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Advanced Solid Tumor

Intervention / Treatment
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* Drug: ICP-192


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed the ICF and Age ≥ 18 years old, either sex. ECOG ≤ 1. Life expectancy of at least 3 months. Part 1 (head and neck cancer cohort): Patients with HNC cancer who have failed or cannot tolerate standard therapy, and with FGF/FGFR gene alteration Part 2 (other solid tumor cohorts): Patients with other solid tumor who have failed or cannot tolerate standard therapy, and with FGF/FGFR gene alteration At least one measurable lesion as the target lesion at screening assessed according to RECIST V1.1 criteria. Exclusion Criteria: Prior treatment with selective FGFR inhibitors or FGFR antibodies. Any corneal or retinal abnormalities that may result in an increased risk of ocular toxicity. Previously or currently endocrine alterations affecting the regulation of calcium-phosphorus homeostasis. History and/or current evidence of extensive tissue calcification.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICP-192<br>20 mg once daily | Drug: ICP-192<br>* ICP-192 is a round, uncoated tablet, 4mg, 5mg. It is administered orally at the dose of 20 mg/day from day 1 to day 21 of each cycle until progression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | ORR based on assessment of confirmed Complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST). | From the time of first dose until objective disease progression, an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of response (DOR) | DOR is time interval from the first date that criteria for complete response or partial response are met to the first date of progression of disease | From the time of first dose until objective disease progression, an average of 6 months | 
| Disease Control Rate (DCR) | DCR based on assessment of confirmed Complete response (CR), partial response (PR) or stable disease(SD) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST). | From the time of first dose until objective disease progression, an average of 6 months |