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

A Multicenter, Open Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of LIT-00814 Tablets in Patients With Advanced Solid Tumor/Esophageal Cancer.

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).

Study Overview

• Status: Enrolling by invitation
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: LIT-00814

• Study Type: Interventional
• Enrollment (Estimated): 81
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • Cancer hospital, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: LIT-00814; LIT-00814 is an oral tablet.
Experimental: 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.	Drug: LIT-00814; LIT-00814 is an oral tablet.
Experimental: 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.	Drug: LIT-00814; LIT-00814 is an oral tablet.
Experimental: 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.	Drug: LIT-00814; LIT-00814 is an oral tablet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective remission rate (ORR)	according to the criterion of RECIST1.1, the proportion of subjects with complete remission (CR) and partial remission (PR) during the study period.	Until documented the disease progresses or informed consent is withdrawn
Disease control rate (DCR)	According to the criterion of RECIST1.1, the proportion of subjects with complete remission (CR), partial remission (PR) and stable disease (SD) during the study period.	Until documented the disease progresses or informed consent is withdrawn
Disease progression-free survival (PFS)	It is defined as the time between the first administration date of the study drug and the disease progression or death, whichever occurs first.	Until documented the disease progresses or informed consent is withdrawn
Treatment onset time (TTR)	It is defined as the time between the first administration date of the study drug and the first determination of complete remission (CR) and partial remission (PR).	Until documented the disease progresses or informed consent is withdrawn
Overall survival (OS)	The time from the first administration date of the study drug to the death (for any reason) of the subject.	date of death from any cause or withdrawal of informed consent
Pharmacokinetic parameters：Maximum observed concentration（Cmax）	Maximum concentration of LIT-00814 in blood after single dose and continuous multiple doses	C0D1-D3 0-72h（single dose），C1D1 0h、C1D8 0h、C2D1 0-8h（21days/cycle）
Pharmacokinetic parameters：Area under the concentration-time curve (AUC)	The concentration of LIT-00814 in blood after single dose and continuous multiple doses	C0D1-D3 0-72h（single dose），C1D1 0h、C1D8 0h、C2D1 0-8h（21days/cycle）
Pharmacokinetic parameters：Half-life (t1/2)	The concentration of LIT-00814 in blood after single dose and continuous multiple doses	C0D1-D3 0-72h（single dose），C1D1 0h、C1D8 0h、C2D1 0-8h（21days/cycle）

Collaborators and Investigators

• Sponsor: LittDD Medicines Ltd
• Investigators: Principal Investigator: Jing Huang, Professor, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2023
• Primary Completion (Estimated): October 30, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 18, 2023
• First Submitted That Met QC Criteria: January 3, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Estimated): March 1, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: LIT-00814-2023-CP101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No