Status:
UNKNOWN
A Clinical Trial of ICP-192 in Treated Patients With Advanced Solid Tumors With FGF/FGFR Gene Alterations
Lead Sponsor:
Beijing InnoCare Pharma Tech Co., Ltd.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05372120
Start Date
December 15 2021
End Date
June 30 2024
Last Update
January 4 2023
Active Locations (37)
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1
The first affiliated hospital of bengbu medical college
Bengbu, Anhui, China, 233000
2
Anhui Provincal Cancer Hospital
Hefei, Anhui, China, 230031
3
Cancer Hospital.Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
4
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142