Actively Recruiting
A Phase I Clinical 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
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetics, and early antitumor effects of AST2303 tablets (also known as ABK3376 tablets) in adults with locally advanced or metastatic non-small cell lung cancer. This phase I clinical trial includes a dose escalation phase and a dose expansion phase, overseen by a safety review committee that evaluates safety, efficacy, and pharmacokinetic data to guide study decisions. Participants receive oral AST2303 tablets once daily on an empty stomach for 21-day cycles. The study tests multiple doses: 25 mg, 50 mg, 75 mg, 100 mg, and 125 mg. The trial is non-randomized and open-label, allowing researchers to monitor the effects and pharmacokinetic properties of each dose level. During the study, participants will be closely monitored for adverse events, serious adverse events, and specific safety concerns for up to two years. Researchers will assess tumor response rates, disease control, duration of relief, progression-free survival, and overall survival. Blood samples and tumor tissue may be collected for genetic testing and pharmacokinetic analysis. The study lasts up to two years, including safety and efficacy follow-up.
CONDITIONS
Brief 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 as per 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 transfusions or hematopoietic growth factor treatment
- Eastern Cooperative Oncology Group (ECoG) performance status score of 0 or 1
- Expected survival time of at least 12 weeks
- Normal swallowing function
- Female participants with fertility must have a negative pregnancy test within 7 days before first dose, be non-lactating, and agree to effective contraception along with male participants with reproductive potential from consent to 6 months after last dose
- Voluntarily sign informed consent after fully understanding the study
You will not qualify if you...
- Previous antitumor therapy targeting the c797s mutation
- Presence of other known driver gene alterations
- Systemic anti-tumor treatment within 2 weeks before first dose or immune checkpoint inhibitors within 4 weeks
- Use of non-specific immunomodulatory agents or traditional Chinese medicine with anti-tumor indications within 2 weeks before first dose
- Use of strong inhibitors or inducers of CYP3A, P-gp, or BCRP within specified time frames before first dose
- Local radiotherapy within 4 weeks or bone radiotherapy within 2 weeks before first dose
- Other malignant tumors besides the primary tumor
- Known meningeal, brainstem, spinal cord metastasis or active brain metastasis unless stable and off certain medications
- Tumor invasion with risk of fistula formation
- Unresolved toxicity from previous anti-tumor treatments above grade 1 (except alopecia and peripheral neuropathy)
- Cardiovascular or cerebrovascular disease or risk factors
- Uncontrollable systemic diseases
- History or current interstitial lung disease or non-infectious pneumonia requiring steroids
- Pulmonary complications causing serious lung damage
- Severe acute or chronic infection
- Long-term systemic corticosteroid or immunosuppressive treatment above specified doses
- Major surgery within 4 weeks before first dose or planned during study
- Significant bleeding symptoms within 4 weeks before first dose
- Serious gastrointestinal dysfunction
- Known hypersensitivity to study drug ingredients
- Pregnant, lactating, or planning pregnancy during the study
- Other factors affecting study results or participant safety as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants take AST2303 Tablets orally once a day on an empty stomach in 21-day cycles at varying doses depending on the study arm.
Visits scheduled according to treatment cycles
Duration - Up to 2 years after treatment ends
Participants are monitored for safety, tolerability, and efficacy outcomes including adverse events and survival for up to 2 years after treatment.
Periodic visits for up to 2 years
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
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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