Status:
ENROLLING_BY_INVITATION
A Phase I Clinical Trial to Evaluate LIT-00814 Tablets in Patients With Advanced Solid Tumor
Lead Sponsor:
LittDD Medicines Ltd
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is a multi-center, open, dose-increasing and dose-expanding phase I clinical study, aiming at evaluating the safety, tolerability, pharmacokinetic characteristics and preliminary anti-tumor...
Eligibility Criteria
Inclusion
- The subject or legal representative shall voluntarily sign the informed consent approved by the Ethics Committee before starting any screening procedure.
- Male or female, age ≥18 years old.
- Unresectable locally advanced or metastatic solid tumor confirmed by histology or cytology.
- Subjects with relapsed and/or metastatic advanced solid tumors who have failed or have no standard treatment at present, or who are unable to accept standard treatment.
- At least one target lesion.
- ECOG score 0\~1.
- Subjects must have sufficient organ function.
- Agree to use effective contraceptive measures within 3 months (about 90 days) from the signing of informed consent to the last administration of the study drug.
Exclusion
- The toxicity caused by previous treatment did not recover to ≤1 grade before the first study administration;
- Known or symptomatic active central nervous system (CNS) metastasis or cancerous meningitis in the screening period;
- Patients who have undergone surgery within 28 days before the first administration and have not recovered yet;
- Suffering from uncontrolled or clinically significant cardiovascular diseases;
- Other malignant tumors occurred within 3 years before the first administration;
- Patients with active chronic hepatitis B, or patients with active hepatitis C, or patients with human immunodeficiency virus (HIV-Ab positive) or syphilis infection;
- There are circumstances that affect the subjects' compliance with the research plan;
- Other circumstances that the researcher thinks are not suitable for participating in this clinical study.
Key Trial Info
Start Date :
October 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT06205082
Start Date
October 14 2023
End Date
June 30 2026
Last Update
March 1 2024
Active Locations (1)
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1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100000