A Phase I/II Clinical Trial of ICP-723 in the Treatment of Advanced Solid Tumors

• Status: Recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

Summary

A Multicenter, Nonrandomized, Open-Label Phase I/IIClinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients with Solid Tumors

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Criteria

Inclusion Criteria:

• Histopathologically confirmed locallyadvanced malignant solid tumors that are unresectable or metastatic andthat are unresponsive tostandard treatments or have relapsed

• Reported NTRK gene fusion in blood and/or tissueor detected in the specified laboratory (Phase II only).

• At least one measurable lesion according to RECIST 1.1.

• ECOG performance status:

• Phase I: ECOG performance status of 0-1;

• Phase II: ECOG performance status of 0-2.

• Life expectancy more than 3 months.

• In fertile female subjects or male subjects,duringthe study period to12 weeks after the last treatment administration,consent to use a medicallyapproved effective contraception method is required.

• Participate voluntarily, sign informed consent, and follow the study treatment plan and scheduled visits.

Exclusion Criteria:

• Received oral fluorouracil chemotherapy within 2 weeks before the first dose of the study drug; received systemic anti-cancer therapy within 4 weeks or 5 half-livesbefore the first dose of study drug.

• Major surgery within 4 weeks or minor surgery within 2 weeks before the first dose of study drug;invasivediagnostictests are not considered surgery

• Clinically significant gastrointestinal dysfunction.

• Known central nervous system (CNS) metastases.

• Uncontrolled or significant cardiovascular disease.

• At the investigator's discretion, evidence of severe or uncontrolled systemic disease

• Known active hepatitis B, or active hepatitis C, or HIV infection.

• Has not recovered from toxicity reactions attributable to prior therapy and above Grade 1

• Pregnant or lactating women;pregnancy is definedfrom conception to the end of pregnancy.

• Has a history of allergic disease, severe drug allergy,and known allergy to any component of ICP-723 tablets.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.