Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients With Advanced Solid Tumors
About the study
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
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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 Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Advanced Solid Tumors
Age (in years)
18+
Phase
Phase 1
Participants needed
30
Est. Completion Date
Jul 31, 2024
Treatment type
Interventional
Sponsor
InnoCare Pharma Inc.
ClinicalTrials.gov identifier
NCT05537987
Study number
ICP-CL-00502
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