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

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

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.

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.