Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients With Advanced Solid Tumors
- Registration Number
- NCT05537987
- Lead Sponsor
- InnoCare Pharma Inc.
- Brief Summary
During this study, dose escalation will be conducted in subjects with advanced solid tumors who have experienced treatment failure after clinical standard of care treatments or who currently have no effective treatment available to evaluate the safety, tolerability, and PK of ICP-723
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Patients with histopathologically confirmed locally advanced malignant solid tumors that are unresectable or metastatic and that are unresponsive to standard treatments or have relapsed; patients who have progressed under standard treatment including prior treatment with TRK or ROS1 inhibitors.
- Male or female patients with age ≥18 years old and ≤80 years old.
- Measurable lesion according to RECIST 1.1.
- Adequate organ functions that meet protocol requirement criteria.
- Patients with asymptomatic, stable primary central nervous system (CNS) tumors or CNS metastases (treated or untreated)
- Participates voluntarily, signs informed consent, and follows the study treatment plan and scheduled visits.
Exclusion Criteria
- Other than the advanced malignant solid tumor under study, patients with another one or more active malignancies within the previous 5 years except for locally curable cancers that have been apparently cured
- Received systemic anti-cancer therapy including chemotherapy (except for oral fluorouracil chemotherapy), radiation therapy, hormones, targeted drugs, or biological immunotherapy within 4 weeks or 5 half-lives
- Major surgery (thoracotomy, laparotomy, etc.) within 4 weeks or minor surgery (superficial skin surgery, lymphadenectomy, hernia repair, etc.) within 2 weeks before the first dose of the study drug
- Clinically significant gastrointestinal/neurological dysfunction that may affect drug intake, transport, or absorption.
- Has evidence of uncontrolled heart disease
- At the investigator's discretion, evidence of severe or uncontrolled systemic disease.
- Other conditions considered by the investigator to be inappropriate for participation in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description ICP-723 ICP-723 -
- Primary Outcome Measures
Name Time Method Incidence and severity of dose-limiting toxicity (DLT), adverse events (AEs), and serious adverse events (SAEs). Frequency of dose interruptions, reductions and intensity through study completion, an average of 1.5 years.
- Secondary Outcome Measures
Name Time Method Objective response rate (ORR) determined using RECIST 1.1 criteria. Through study completion, an average of 4 years Half-life (t1/2) Through study completion, an average of 4 years Apparent volume of distribution (Vz/F), Through study completion, an average of 4 years Disease control rate (DCR) determined using RECIST 1.1 criteria. Through study completion, an average of 4 years Apparent clearance (CL/F) Through study completion, an average of 4 years Peak concentration (Cmax) Through study completion, an average of 4 years Time to reach peak concentration (Tmax) Through study completion, an average of 4 years Area under the plasma concentration-time curve (AUC0-∞ and AUC0-t) Through study completion, an average of 4 years
Trial Locations
- Locations (3)
NYU-Langone Medical Center
🇺🇸New York, New York, United States
University of Kansas Medical / Cancer Centers
🇺🇸Kansas City, Kansas, United States
Northwest Medical Specialties
🇺🇸Tacoma, Washington, United States