Actively Recruiting
A Phase I/II Study of ABSK141 in Patients With Advanced Solid Tumors ( ABSK141-101 )
Led by Abbisko Therapeutics Co, Ltd · Updated on 2026-03-11
401
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a first-in-human (FIH), exploratory, multicenter, open-label, phase I/II study of ABSK141 in patients with advanced solid tumors to to evaluate safety, tolerability, PK and optimize the dosage.
CONDITIONS
Official Title
A Phase I/II Study of ABSK141 in Patients With Advanced Solid Tumors ( ABSK141-101 )
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must understand and sign informed consent before screening
- Male or female age 18 years or older
- Histologically confirmed locally advanced or metastatic solid tumors
- For escalation backfill cohorts: solid tumors with KRAS G12D mutation including colorectal cancer, non-small cell lung cancer, or pancreatic ductal adenocarcinoma
- Must have at least one measurable target lesion according to RECIST 1.1
- For expansion part: solid tumors with KRAS G12D mutation including colorectal cancer, non-small cell lung cancer, pancreatic ductal adenocarcinoma, or other solid tumors
- For phase II: locally advanced or metastatic solid tumors with disease progression after or intolerance to standard treatment, or no standard treatment available
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ and bone marrow function per screening within 14 days before first dose
- For food effect exploration participants: able to eat a standardized high-fat, high-calorie meal within 30 minutes and fast for 10 hours
You will not qualify if you...
- Known allergy or hypersensitivity to any component of ABSK141
- Previous treatment with investigational KRAS G12D inhibitors, pan- or multi-RAS inhibitors, or direct RAS-targeted therapy (for backfill cohorts and expansion part)
- Active additional progressing malignancy requiring treatment
- Unable to swallow capsules or tablets or have significant gastrointestinal disorders affecting absorption
- Anti-tumor therapy within 2 weeks or 5 half-lives (whichever is shorter), or radiotherapy/antibody therapy within 4 weeks before study
- Major surgery within 4 weeks before first dose with unhealed wounds or infections
- Prior toxicities from cancer therapies not resolved to Grade 1 or less
- Use of proton pump inhibitors or certain CYP3A and P-gp inhibitors/inducers within specified timeframes
- Active central nervous system metastases
- History of interstitial lung disease requiring steroids
- Significant cardiac disease
- Non-small cell lung cancer patients with other driver mutations without targeted therapy
- Known HIV infection or AIDS-related illness
- Hepatitis infection
- Uncontrolled ascites or pleural effusion
- Pregnant or nursing women
- Refusal to use effective birth control during and after study
- Vaccination with live attenuated vaccines within 4 weeks before first dose
- Planned major surgery during study
- Any other clinically significant comorbidities
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China, 201321
Actively Recruiting
Research Team
Y
Yu Zhang, Bachelor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
6
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