Advanced Solid Tumor
Conditions
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.
Interventions
DRUGICP-192
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
Sponsors
Beijing InnoCare Pharma Tech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | From the time of first dose until objective disease progression, an average of 6 months | Progression free survival is the time period from start of study medication till the disease progression or death, whichever occurs first. |
| Overall survival (OS) | From the time of first dose until objective disease progression, an average of 1 year | OS is the time period from start of study medication untill death from any cause. |
Countries
China
Contacts
Primary ContactYe Guo
Outcome results
None listed