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

Beijing InnoCare Pharma Tech Co., Ltd.36 sites in 1 country200 target enrollmentDecember 15, 2021

ConditionsAdvanced Solid Tumor

InterventionsICP-192

DrugsICP-192

Overview

Phase: Phase 2
Intervention: ICP-192
Conditions: Advanced Solid Tumor
Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.
Enrollment: 200
Locations: 36
Primary Endpoint: Objective response rate (ORR)
Status: Recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 15, 2021

End Date

June 30, 2024

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Beijing InnoCare Pharma Tech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Signed the ICF and Age ≥ 18 years old, either sex.
•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.

Arms & Interventions

ICP-192

20 mg once daily

Intervention: ICP-192

Outcomes

Primary Outcomes

Objective response rate (ORR)

Time Frame: From the time of first dose until objective disease progression, an average of 6 months

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).

Secondary Outcomes

Duration of response (DOR)(From the time of first dose until objective disease progression, an average of 6 months)
Disease Control Rate (DCR)(From the time of first dose until objective disease progression, an average of 6 months)