A Phase I Clinical Trial to Evaluate LIT-00814 Tablets in Patients With Advanced Solid Tumor

NCT ID: NCT06205082

Last Updated: 2024-03-01

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE1
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-14
• Study Completion Date: 2026-06-30

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 activity of LIT-00814 tablets with different doses in China, and preliminarily evaluating the relationship between biomarkers and anti-tumor activity of LIT-00814 tablets.

This study includes two parts: Ia phase (i.e. dose escalation) and Ib phase (i.e. dose expansion).

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LIT-00814 20mg

Take a fixed dose of LIT-00814 tablets orally once a day in the morning and evening, and take them orally continuously.

Group Type: EXPERIMENTAL

LIT-00814

Intervention Type: DRUG

LIT-00814 is an oral tablet.

LIT-00814 50mg

Take a fixed dose of LIT-00814 tablets orally once a day in the morning and evening, and take them orally continuously.

Group Type: EXPERIMENTAL

LIT-00814

Intervention Type: DRUG

LIT-00814 is an oral tablet.

LIT-00814 100mg

Take a fixed dose of LIT-00814 tablets orally once a day in the morning and evening, and take them orally continuously.

Group Type: EXPERIMENTAL

LIT-00814

Intervention Type: DRUG

LIT-00814 is an oral tablet.

LIT-00814 150mg

Take a fixed dose of LIT-00814 tablets orally once a day in the morning and evening, and take them orally continuously.

Group Type: EXPERIMENTAL

LIT-00814

Intervention Type: DRUG

LIT-00814 is an oral tablet.

Interventions

LIT-00814

LIT-00814 is an oral tablet.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. The subject or legal representative shall voluntarily sign the informed consent approved by the Ethics Committee before starting any screening procedure.

2. Male or female, age ≥18 years old.

3. Unresectable locally advanced or metastatic solid tumor confirmed by histology or cytology.

4. 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.

5. At least one target lesion.

6. ECOG score 0~1.

7. Subjects must have sufficient organ function.

8. 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 Criteria

1. The toxicity caused by previous treatment did not recover to ≤1 grade before the first study administration;

2. Known or symptomatic active central nervous system (CNS) metastasis or cancerous meningitis in the screening period;

3. Patients who have undergone surgery within 28 days before the first administration and have not recovered yet;

4. Suffering from uncontrolled or clinically significant cardiovascular diseases;

5. Other malignant tumors occurred within 3 years before the first administration;

6. Patients with active chronic hepatitis B, or patients with active hepatitis C, or patients with human immunodeficiency virus (HIV-Ab positive) or syphilis infection;

7. There are circumstances that affect the subjects' compliance with the research plan;

8. Other circumstances that the researcher thinks are not suitable for participating in this clinical study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LittDD Medicines Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jing Huang, Professor

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

LIT-00814-2023-CP101

Identifier Type: -

Identifier Source: org_study_id