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

NCT06205082 | Enrolling By Invitation Phase 1

• 1 other identifier: LIT-00814-2023-CP101
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events

  Up to 28 days post last drug administration

• Determination of the MTD and RP2D of LIT-00814 monotherapy

  Defined as the highest dose level at which no more than 1 of 6 subjects experience a DLT during the DLT assessment window（24days）

  24 days after the first dose

Secondary Outcomes (8)

• Objective remission rate (ORR)

  Until documented the disease progresses or informed consent is withdrawn

• Disease control rate (DCR)

  Until documented the disease progresses or informed consent is withdrawn

• Disease progression-free survival (PFS)

  Until documented the disease progresses or informed consent is withdrawn

• Treatment onset time (TTR)

  Until documented the disease progresses or informed consent is withdrawn

• Overall survival (OS)

  date of death from any cause or withdrawal of informed consent

Study Arms (4)

LIT-00814 20mg

EXPERIMENTAL

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

Drug: LIT-00814

LIT-00814 50mg

EXPERIMENTAL

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

Drug: LIT-00814

LIT-00814 100mg

EXPERIMENTAL

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

Drug: LIT-00814

LIT-00814 150mg

EXPERIMENTAL

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

Drug: LIT-00814

Interventions

LIT-00814 DRUG

LIT-00814 is an oral tablet.

LIT-00814 100mg; LIT-00814 150mg; LIT-00814 20mg; LIT-00814 50mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LittDD Medicines Ltd: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100000, China

Location

Study Officials

• Jing Huang, Professor

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 12, 2024
• Study Start: October 14, 2023
• Primary Completion: October 30, 2025
• Study Completion: June 30, 2026
• Last Updated: March 1, 2024

Record last verified: 2024-02

Locations

CN (1)