Cancer
ICP-CL-003030
A multi-center open-label, phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ICP-192 in patients with advanced solid tumours and FGFR gene alterations
Trial overview
Topic
Basket – Solid Tumours
Eligibility criteria
- Participate voluntarily, sign informed consent, and follow the study treatment plan
and scheduled visits. - Phase I: Patients with histologically or cytologically confirmed unresectable or
metastatic advanced malignant solid tumours who have progressed under standard
treatment or recurred after or were intolerant to all standard treatment regimens, or
have no standard treatment available. - Phase II: patients with histologically or cytologically confirmed unresectable or
metastatic urothelial carcinoma or cholangiocarcinoma, who have progressed or recurred
after or were intolerant to first-line chemotherapy, or have progressed/relapsed
within 12 months after neoadjuvant /adjuvant chemotherapy. - Phase II: Existing test reports have confirmed the FGFR gene alteration or the central
laboratory has detected the FGFR gene alteration.- Age =18 years old
- At least one measurable lesion according to the Response Evaluation Criteria of Solid
Tumour, version 1.1 (RECIST 1.1) - ECOG performance status of 0-1
- Life expectancy for more than 3 months; Must have adequate organ function Major
Study details
A multi-center open-label, phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ICP-192 in patients with advanced solid tumours and FGFR gene alterations
Further information
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