Clinical trial NCT06205082: A Phase I Clinical Trial to Evaluate LIT-00814 Tablets in Patients With Advanced Solid Tumor
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.
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: LittDD Medicines Ltd
Sponsor class: INDUSTRY
First posted: 2024-01-12
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 28 days post last drug administration
measure: Determination of the MTD and RP2D of LIT-00814 monotherapy
timeFrame: 24 days after the first dose
Secondary outcomes:
measure: Objective remission rate (ORR)
timeFrame: Until documented the disease progresses or informed consent is withdrawn
measure: Disease control rate (DCR)
timeFrame: Until documented the disease progresses or informed consent is withdrawn
measure: Disease progression-free survival (PFS)
timeFrame: Until documented the disease progresses or informed consent is withdrawn
measure: Treatment onset time (TTR)
timeFrame: Until documented the disease progresses or informed consent is withdrawn
measure: Overall survival (OS)
timeFrame: date of death from any cause or withdrawal of informed consent
measure: Pharmacokinetic parameters：Maximum observed concentration（Cmax）
timeFrame: C0D1-D3 0-72h（single dose），C1D1 0h、C1D8 0h、C2D1 0-8h（21days/cycle）
measure: Pharmacokinetic parameters：Area under the concentration-time curve (AUC)
timeFrame: C0D1-D3 0-72h（single dose），C1D1 0h、C1D8 0h、C2D1 0-8h（21days/cycle）
measure: Pharmacokinetic parameters：Half-life (t1/2)
timeFrame: C0D1-D3 0-72h（single dose），C1D1 0h、C1D8 0h、C2D1 0-8h（21days/cycle）
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Jing Huang, Professor
role: PRINCIPAL_INVESTIGATOR
References: