Actively Recruiting
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AST2303 Tablets (ABK3376 Tablets) in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
Led by Allist Pharmaceuticals, Inc. · Updated on 2026-02-12
120
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multicenter, single arm, open label, phase I clinical trial, including dose escalation (phase IA) and dose expansion (phase IB). This study aimed to evaluate the safety, tolerability, PK characteristics and preliminary antitumor activity of ast2303 tablets (abk3376 tablets) in subjects with locally advanced or metastatic non-small cell lung cancer. A safety review committee (SRC) was established in this study, which will review the safety, efficacy, pharmacokinetics and other data obtained from the study, and make decisions on key issues such as dose escalation and dose expansion.
CONDITIONS
Official Title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AST2303 Tablets (ABK3376 Tablets) in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of signing informed consent
- Confirmed diagnosis of non-small cell lung cancer by tissue or cytology
- At least one target lesion without local treatment according to RECIST 1.1 criteria
- Agree to provide blood and/or tumor tissue samples for genetic testing
- Good bone marrow and organ function without recent blood transfusion or growth factor treatment
- ECOG physical status score of 0 or 1
- Expected survival time of 12 weeks or more
- Normal swallowing function
- Female participants of childbearing potential must have a negative pregnancy test within 7 days before first treatment and not be breastfeeding
- Effective contraception required from informed consent until 6 months after last treatment for participants with reproductive potential
You will not qualify if you...
- Previous antitumor treatment targeting the c797s mutation
- Carry other known driver gene alterations
- Received systemic anti-tumor treatment within 2 weeks before first dose or within 5 half-lives of the drug
- Received immune checkpoint inhibitors within 4 weeks before first dose
- Received cytotoxic drugs with delayed toxicity within 6 weeks before first dose
- Received non-specific immunomodulatory agents or traditional Chinese medicine with anti-tumor indication within 2 weeks before first dose
- Used strong CYP3A, P-gp, or BCRP inhibitors or inducers shortly before first dose
- Received local radiotherapy within 4 weeks before first dose (2 weeks for bone radiotherapy)
- Have other malignant tumors besides primary
- Have active meningeal, brainstem, spinal cord metastases or compression, or unstable brain metastases
- Tumor invading important organs or vessels with risk of fistula
- Previous anti-tumor treatment toxicity not resolved to grade 1 or less except alopecia and peripheral neuropathy
- Presence of cardiovascular or cerebrovascular disease or risk factors
- Uncontrollable systemic diseases
- History or presence of interstitial lung disease or non-infectious pneumonia requiring steroids
- Serious lung damage from pulmonary complications or underlying lung diseases
- Severe acute or chronic infection
- On long-term systemic corticosteroids above specified dose or immunosuppressive treatment
- Major surgery within 4 weeks before first dose or planned during study
- Significant bleeding symptoms or bleeding tendency within 4 weeks before first dose
- Serious gastrointestinal dysfunction or disorders
- Known hypersensitivity to study drug ingredients
- Pregnant or lactating women or planning pregnancy during study
- Other factors affecting study results or safety such as substance abuse, serious diseases, abnormal labs, or social factors
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
Research Team
S
Shanghai Allist Pharmaceuticals Co., Ltd Shanghai Allist Pharmaceuticals Co., Ltd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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