A Phase 1/2 interventional study of Drug ICP-192 in Advanced Solid Tumors, Urothelial Carcinoma and Cholangiocarcinoma, sponsored by Beijing InnoCare Pharma Tech Co., Ltd.. Status unknown at 16 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-14.
Sponsored by Beijing InnoCare Pharma Tech Co., Ltd. · Phase 1/2, Interventional, and Treatment
This is a multi-center, open-label, phase I/II clinical study to evaluate ICP-192 in patients with advanced solid tumors and FGFR gene alterations. It consists of two parts: Part I (Phase I), dose escalation and Part II (Phase II), dose expansion.
Part I (Phase I) of the study enrolls patients with advanced solid tumors (9-15 patients); Part II (Phase II) of the study enrolls patients with urothelial carcinoma or cholangiocarcinoma with FGFR genetic alterations (30 patients).
913 studies on the registry are indexed under Cholangiocarcinoma; 285 are open to participants now.
This study's planned enrollment of 45 is close to the median of 50 across 686 interventional studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →Beijing InnoCare Pharma Tech Co., Ltd. is the lead sponsor of 57 studies on the registry; 34 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Major Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Participants are excluded from the study if any of the following criteria apply:
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
1. Dose Escalation Phase ICP-192 2. Dose Expansion Phase ICP-192
Drug: Drug ICP-192
1. Dose Escalation Phase ICP-192 will be taken by patients with advanced solid tumor and will be treated follow the "3+3" dose escalation scheme 2. Dose Expansion Phase ICP-192 will be taken by patients with urothelial carcinoma or cholangiocarcinoma with FGFR gene alterations and will be treated at a single dose defined from the Dose Escalation Phase.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Phase I: Dose Escalation \& Phase II: Dose Expansion To evaluate the safety and tolerability of different doses of ICP-192 in patients with advanced solid tumors
Time frame: Up to 3 years
MTD
Phase I: Dose Escalation To determine Maximum Tolerated Dose(MTD) for ICP-192
Time frame: Up to 3 years
OBD
Phase I: Dose Escalation To determine Optimal Biological Dose (OBD) for ICP-192
Time frame: Up to 3 years
RP2D
Phase I: Dose Escalation To determine Recommended Phase 2 Dose (RP2D) for ICP-192
Time frame: Up to 3 years
ORR
Phase II: Dose Expansion Objective Response Rate
Time frame: Up to 3 years
Peak concentration (Cmax)
Phase I: Dose Escalation Peak concentration (Cmax)
Time frame: Up to 3 years
AUC
Phase I: Dose Escalation AUC
Time frame: Up to 3 years
DCR
Phase II: Dose Expansion disease control rate
Time frame: Up to 3 years
DOR
Phase II: Dose Expansion duration of response
Time frame: Up to 3 years
PFS
Phase II: Dose Expansion progression-free survival
Time frame: Up to 3 years
OS
Phase II: Dose Expansion overall survival
Time frame: Up to 3 years
Drug exposure
Phase II: Dose Expansion Assessment of the correlations between drug exposure (e.g., AUC, Cmax) and patient response to ICP-192.
Time frame: Up to 3 years
PD biomarker
Phase II: Dose Expansion Assessment of the correlations between PD biomarker and patient response to ICP-192.
Time frame: Up to 3 years
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Beijing InnoCare Pharma Tech Co., Ltd.