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New treatment option for Solid Tumors, Adult
Official title A Phase I/II Study of ABSK141 in Patients With Advanced Solid Tumors ( ABSK141-101 )
ClinicalTrials.gov ID: NCT07417189
What this study is testing
What is ABSK141-400mg?
ABSK141-400mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for solid tumors, adult.
Also referred to as ABSK141, investigational drug.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 . For backfill cohorts in the escalation part:
- Patients must have the following solid tumor harboring KRAS G12D mutation:
- Colorectal cancer (CRC);
You likely can't join if
- 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...
- 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...
- Previous anti-tumor therapy, including chemotherapy, endocrine therapy, molecular targeted therapy or other investigational drugs received ≤2 weeks...
- 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
See the full eligibility 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 . For backfill cohorts in the escalation part:
- 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 For expansion Part:
- Patients must have the following solid tumor harboring KRAS G12D mutation:
- Colorectal cancer (CRC);
- Non-small cell lung cancer (NSCLC);
- Pancreatic ductal adenocarcinoma (PDAC);
- Other solid tumors;
- Patients must have at least one measurable target lesion according to RECIST 1.1 For phase II:
- Patients with locally advanced or metastatic solid tumors confirmed by histological examination, whose disease has progressed after standard treatment or who are intolerant to standard treatment, or for whom there is...
- Patients must have the following solid tumor harboring KRAS G12D mutation:
- Colorectal cancer (CRC);
- Non-small cell lung cancer (NSCLC);
- Pancreatic ductal adenocarcinoma (PDAC);
- Other solid tumors;
- Patients must have at least one measurable target lesion according to RECIST 1.1 4. ECOG performance status 0 or 1 5. Adequate organ function and bone marrow function as indicated by the following screening assessments...
- 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
- 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...
- 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...
- 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.
- P-gp inhibitor and strong CYP3A inhibitors to 7 days or 5 half-lives whichever is longer and for CYP3A inducers to 2 weeks or 5 half-lives
- Active central nervous system (CNS) metastases
- History of interstitial lung disease requiring systemic steroid treatment.
- Impaired cardiac function or clinically significant cardiac disease
- NSCLC cohorts: Patient previously identified as having a driver mutation (according to local standard of care or guidelines) and have not received any targeted therapy, for example: EGFR mutation, ALK rearrangement...
- Known acquired immunodeficiency syndrome (AIDS)-related illness, or positive test for HIV 1/2 antibody
- Exclusion of hepatitis infection
- Patients with refractory/uncontrolled ascites or pleural effusion
- Pregnant or nursing (lactating) women
- refuse to use highly effective methods of birth control during the study and for up to 6 months after the last dose of study drug.
- Sexually active males who refuse to use a condom during intercourse while taking drug and for 5 consecutive compound half-lives plus 60 days after stopping study drug.
- Vaccination with a live, attenuated vaccine within 4 weeks prior to the first dose of study treatment except for administration of inactivate vaccines
- Planned major surgery during study treatment
- Any other clinically significant comorbidities
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.