A Phase I/II Study of ABSK141 in Patients With Advanced Solid Tumors ( ABSK141-101 ) (NCT07417189) | Clinical Trial Compass
RecruitingPhase 1/2
A Phase I/II Study of ABSK141 in Patients With Advanced Solid Tumors ( ABSK141-101 )
China401 participantsStarted 2026-03-02
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients should understand, sign, and date the written informed consent form prior to screening
. Male or female age 18 years or older
. Patients with histologically confirmed locally-advanced or metastatic solid tumors .
. Patients must have the following solid tumor harboring KRAS G12D mutation:
. Colorectal cancer (CRC);
. Non-small cell lung cancer (NSCLC);
. Pancreatic ductal adenocarcinoma (PDAC);
. Patients must have at least one measurable target lesion according to RECIST 1.1
Exclusion criteria
. Known allergy or hypersensitivity to any component of the investigational product
. (For backfill cohorts and expansion part) Patients who were previously treated with an investigational KRAS G12D inhibitor, pan- or multi-RAS inhibitor, or had prior therapy with any direct RAS-targeted therapy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of DLTs
Timeframe: from Run-in to Day28
2
Incidence and severity of AEs
Timeframe: from the time that the patient provides informed consent through and including 30 days after the last administration of ABSK141.
3
Incidence and severity of SAEs
Timeframe: from the time that the patient provides informed consent through and including 30 days after the last administration of ABSK141.
. Has a known additional malignancy that is progressing or has required active treatment
. Unable to swallow capsules or tablets or malabsorption syndrome, disease significantly affecting GI function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction. If any of these conditions exist, the site should discuss with the sponsor to determine patient eligibility
. Previous anti-tumor therapy, including chemotherapy, endocrine therapy, molecular targeted therapy or other investigational drugs received ≤2 weeks or ≤5-half life (whichever is shorter), radiotherapy and antibody therapy received ≤4 weeks prior to initiation of study treatment
. Major surgery within 4 weeks of the first dose of study drug. Note that all surgical wounds must be healed and free of infection or dehiscence
. Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy, that have not regressed to Grade ≤1 severity (CTCAE v5.0)
. Patients should not use proton pump inhibitors for at least 7 days prior to the first dose of ABSK141 and during treatment with ABSK141.