Brief Summary
This is a multi-center, open-label, phase I/II clinical study to evaluate ICP-192 in patients with advancedat a late stage, far along solid tumors and FGFR gene alterations. It consists of two parts: Part I (Phase I), dosethe amount of medication taken escalation and Part II (Phase II), dose expansion.
Intervention / Treatment
- Drug: Drug ICP-192
Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
- Participate voluntarily, sign informed consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment., and follow the study treatment plan and scheduled visits;
- Phase I: Patients with histologically or cytologically confirmed unresectable or metastatic advanced malignantcancerous, may grow and spread to other areas of the body solid tumors 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 carcinomacancer arising from tissues that line organs or cholangiocarcinoma, who have progressed or recurred after or were intolerant to first-line chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells, 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 Tumor, 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 Exclusion Criteria