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

Advanced Solid Tumor Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06205082
• Other study ID #: LIT-00814-2023-CP101
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: October 14, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: February 2024
• Source: LittDD Medicines Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 81
• Est. completion date: June 30, 2026
• Est. primary completion date: October 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• LIT-00814
LIT-00814 is an oral tablet.

Locations

Country	Name	City	State
China	Cancer Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
LittDD Medicines Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events		Up to 28 days post last drug administration
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)