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

Phase 2

Recruiting

• Conditions: Advanced Solid Tumor
• Interventions: Drug: ICP-192

• Registration Number: NCT05372120
• Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-15
• Study First Submitted: 2022-05-08
• Study First Submitted QC: 2022-05-08
• Study First Posted: 2022-05-12
• Status Verified: 2022-12
• Last Update Submitted: 2023-01-03
• Last Update Posted: 2023-01-04
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Signed the ICF and Age ≥ 18 years old, either sex.
2. ECOG ≤ 1.
3. Life expectancy of at least 3 months.
4. 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
5. 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
6. At least one measurable lesion as the target lesion at screening assessed according to RECIST V1.1 criteria.

Exclusion Criteria

1. Prior treatment with selective FGFR inhibitors or FGFR antibodies.
2. Any corneal or retinal abnormalities that may result in an increased risk of ocular toxicity.
3. Previously or currently endocrine alterations affecting the regulation of calcium-phosphorus homeostasis. History and/or current evidence of extensive tissue calcification.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ICP-192	ICP-192	20 mg once daily

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	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 Outcome Measures

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

Trial Locations

Locations (36)

The first affiliated hospital of bengbu medical college; 🇨🇳 Bengbu, Anhui, China

Anhui Provincal Cancer Hospital; 🇨🇳 Hefei, Anhui, China

Cancer Hospital.Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Fujian Cancer Hospital; 🇨🇳 Fuzhou, Fujian, China

The First Affiliated Hospital of Lanzhou University; 🇨🇳 Lanzhou, Gansu, China

Affiliated Cancer Hospital and Institute of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China

The Second Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

Harbin Medical University cancer hospital; 🇨🇳 Harbin, Heilongjiang, China

Scroll for more (26 remaining)