Solid Tumors, AdultPhase 1/2NCT07417189
A Phase I/II Study of ABSK141 in Patients With Advanced Solid Tumors ( ABSK141-101 )
A Phase 1/2 study testing ABSK141-400mg, ABSK141-Recommended Dose for Expansion (RDE) and ABSK141-800mg in people with Solid Tumors, Adult, run by Abbisko Therapeutics Co, Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Adult
- What is being tested?
- ABSK141-400mg, ABSK141-Recommended Dose for Expansion (RDE) and ABSK141-800mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 401 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2026to 30 Jul 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
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- 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 currently no standard treatment.
- 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 performed within 14 days prior to the first dose of study drug 6. For patients participating exploration of food effect:
- be able to eat a standardized high-fat, high caloric meal within 30 minutes (2) be able to fast for 10 hours
Who cannot join
- 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 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
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- 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, KRAS G12C mutation, NTRK1/2/3 gene fusion, RET fusion, MET exon14 skipping mutation, BRAF V600E mutation, ROS1 rearrangement, etc
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 201321
xianjun Yu, doctor
About this study
Official title: A Phase I/II, Open-Label Study of ABSK141 to Assess Safety, Tolerability, Efficacy and Pharmacokinetics in Patients With KRAS G12D Mutant Advanced Solid Tumors
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.
Read the detailed description
The study will start with a dose escalation of oral ABSK141 in patients with advanced solid tumors harboring KRAS G12D mutation to evaluate safety, tolerability, and PK. The expansion part will investigate oral ABSK141 at the recommended doses for expansion (RDEs) to evaluate safety and efficacy among selected tumor types harboring KRAS G12D mutation and optimize the dosage.
The phase II study will further investigate oral ABSK141 at the recommended phase 2 doses (RP2Ds) to evaluate safety and efficacy among selected tumor types harboring KRAS G12D mutation.
- Conditions
- Solid Tumors, Adult
- Being tested
- ABSK141-400mg, ABSK141-Recommended Dose for Expansion (RDE), ABSK141-800mg, ABSK141-1200mg, ABSK141-Recommended Phase 2 dose (RP2D)
- Keywords
- ABSK141, KRAS G12D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABSK141-400mgDrug
Also called ABSK141, investigational drug
In the escalation part#patients will first orally receive a single dose of ABSK141 on D-3, followed by a three-day run-in period to assess the PK profile of singledose ABSK141 400mg administration. Thereafter, patients will continuously receive ABSK141 400mg once daily (QD).
ABSK141-Recommended Dose for Expansion (RDE)Drug
Also called ABSK141, investigational drug
In the expansion part# patients will orally receive ABSK141 at the recommended dose for expansion (RDE).patients will continuously receive ABSK141 Recommended Dose for Expansion (RDE) once daily (QD).
ABSK141-800mgDrug
Also called ABSK141, investigational drug
In the escalation part#patients will first orally receive a single dose of ABSK141 on D-3, followed by a three-day run-in period to assess the PK profile of singledose ABSK141 800mg administration. Thereafter, patients will continuously receive ABSK141 800mg once daily (QD).
ABSK141-1200mgDrug
Also called ABSK141, investigational drug
In the escalation part#patients will first orally receive a single dose of ABSK141 on D-3, followed by a three-day run-in period to assess the PK profile of singledose ABSK141 1200mg administration. Thereafter, patients will continuously receive ABSK141 1200mg once daily (QD).
ABSK141-Recommended Phase 2 dose (RP2D)Drug
Also called ABSK141, investigational drug
Phase II #patients will orally receive ABSK141 at the Recommended Phase 2 Dose (RP2D).
| Study group | Role | What they receive |
|---|---|---|
| Escalation part-400mg | Experimental | ABSK141 (investigational drug) tablet, 400 mg administered orally once daily (QD), continuously until disease progression. Receives: Drug: ABSK141-400mg |
| expansion part | Experimental | ABSK141 (investigational drug) tablet,Recommended Dose for Expansion (RDE) administered orally once daily (QD), continuously until disease progression. Receives: Drug: ABSK141-Recommended Dose for Expansion (RDE) |
| Escalation part-800mg | Experimental | ABSK141 (investigational drug) tablet, 800 mg administered orally once daily (QD), continuously until disease progression. Receives: Drug: ABSK141-800mg |
| Escalation part-1200mg | Experimental | ABSK141 (investigational drug) tablet, 1200 mg administered orally once daily (QD), continuously until disease progression. Receives: Drug: ABSK141-1200mg |
| Backfill cohorts | Experimental | ABSK141 (investigational drug) tablet, The decision-making on doses for backfill cohorts will be based on the discussion and alignment between the Sponsor and Investigator. Receives: Drug: ABSK141-Recommended Dose for Expansion (RDE) |
| Phase II | Experimental | ABSK141 (investigational drug) tablet, administered at the Recommended Phase 2 Dose (RP2D) continuously until disease progression. Receives: Drug: ABSK141-Recommended Phase 2 dose (RP2D) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DLTs
dose-limiting toxicities
Measured: from Run-in to Day28
Incidence and severity of AEs
Adverse events
Measured: from the time that the patient provides informed consent through and including 30 days after the last administration of ABSK141.
Incidence and severity of SAEs
serious adverse events
Measured: from the time that the patient provides informed consent through and including 30 days after the last administration of ABSK141.
Secondary outcomes (10)
Cmax
maximum observed concentration
Measured: From pre-dose to up to 72 hours post-dose
AUC
area under the concentration-time curve
Measured: From pre-dose to up to 72 hours post-dose
t1/2
elimination half-life
Measured: From pre-dose to up to 72 hours post-dose
CL/F
apparent oral clearance
Measured: From pre-dose to up to 72 hours post-dose
tmax
time to maximum observed concentration
Measured: From pre-dose to up to 72 hours post-dose
ORR
Objective response rate
Measured: From the first dose date to the date of first confirmed response (CR/PR), assessed up to 24 months.
DOR
Duration of response
Measured: From date of first confirmed response (CR/PR) to date of first documented progression (PD) or death from any cause, whichever comes first, assessed up to 24 months.
PFS
Progression-free survival
Measured: From the first dose date to the date of first documented progressive disease (PD) or death from any cause, whichever occurs first, assessed up to 24 months.
DCR
Disease control rate
Measured: From the first dose date to the date of first documented disease status assessment (CR/PR/SD/PD), assessed up to 24 months.
OS
Overall survival
Measured: From the first dose date to the date of death from any cause, assessed up to24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start2 Mar 2026
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumors, AdultStudies of the same condition, open and under way.
- More trials run by Abbisko Therapeutics Co, LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 401 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbisko Therapeutics Co, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xianjun Yu, Doctor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417189
- Sponsor's protocol ID
- ABSK141-101
- Status last verified
- Mar 2026
- First submitted
- 28 Jan 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Open-Label Study of ABSK141 to Assess Safety, Tolerability, Efficacy and Pharmacokinetics in Patients With KRAS G12D Mutant Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07417189
- Acronym / sponsor ID
- ABSK141-101
- Conditions
- Solid Tumors, Adult
- Keywords
- ABSK141, KRAS G12D
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 401 participants (estimated)
- Lead sponsor
- Abbisko Therapeutics Co, LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will start with a dose escalation of oral ABSK141 in patients with advanced solid tumors harboring KRAS G12D mutation to evaluate safety, tolerability, and PK. The expansion part will investigate oral ABSK141 at the recommended doses for expansion (RDEs) to evaluate safety and efficacy among selected tumor types harboring KRAS G12D mutation and optimize the dosage.
The phase II study will further investigate oral ABSK141 at the recommended phase 2 doses (RP2Ds) to evaluate safety and efficacy among selected tumor types harboring KRAS G12D mutation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Escalation part-400mg | Experimental | Drug: ABSK141-400mgABSK141 (investigational drug) tablet, 400 mg administered orally once daily (QD), continuously until disease progression. |
| expansion part | Experimental | Drug: ABSK141-Recommended Dose for Expansion (RDE)ABSK141 (investigational drug) tablet,Recommended Dose for Expansion (RDE) administered orally once daily (QD), continuously until disease progression. |
| Escalation part-800mg | Experimental | Drug: ABSK141-800mgABSK141 (investigational drug) tablet, 800 mg administered orally once daily (QD), continuously until disease progression. |
| Escalation part-1200mg | Experimental | Drug: ABSK141-1200mgABSK141 (investigational drug) tablet, 1200 mg administered orally once daily (QD), continuously until disease progression. |
| Backfill cohorts | Experimental | Drug: ABSK141-Recommended Dose for Expansion (RDE)ABSK141 (investigational drug) tablet, The decision-making on doses for backfill cohorts will be based on the discussion and alignment between the Sponsor and Investigator. |
| Phase II | Experimental | Drug: ABSK141-Recommended Phase 2 dose (RP2D)ABSK141 (investigational drug) tablet, administered at the Recommended Phase 2 Dose (RP2D) continuously until disease progression. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 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:
- Patients must have at least one measurable target lesion according to RECIST 1.1
Key exclusion criteria (22 listed)
- 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 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABSK141-400mgAlso: ABSK141, investigational drugIn the escalation part#patients will first orally receive a single dose of ABSK141 on D-3, followed by a three-day run-in period to assess the PK profile of singledose ABSK141 400mg administration. Thereafter, patients will continuously receive ABSK141 400mg once daily (QD). | Drug | Escalation part-400mg |
| ABSK141-Recommended Dose for Expansion (RDE)Also: ABSK141, investigational drugIn the expansion part# patients will orally receive ABSK141 at the recommended dose for expansion (RDE).patients will continuously receive ABSK141 Recommended Dose for Expansion (RDE) once daily (QD). | Drug | Backfill cohorts, expansion part |
| ABSK141-800mgAlso: ABSK141, investigational drugIn the escalation part#patients will first orally receive a single dose of ABSK141 on D-3, followed by a three-day run-in period to assess the PK profile of singledose ABSK141 800mg administration. Thereafter, patients will continuously receive ABSK141 800mg once daily (QD). | Drug | Escalation part-800mg |
| ABSK141-1200mgAlso: ABSK141, investigational drugIn the escalation part#patients will first orally receive a single dose of ABSK141 on D-3, followed by a three-day run-in period to assess the PK profile of singledose ABSK141 1200mg administration. Thereafter, patients will continuously receive ABSK141 1200mg once daily (QD). | Drug | Escalation part-1200mg |
| ABSK141-Recommended Phase 2 dose (RP2D)Also: ABSK141, investigational drugPhase II #patients will orally receive ABSK141 at the Recommended Phase 2 Dose (RP2D). | Drug | Phase II |
Primary outcome
Incidence of DLTs
Time frame: from Run-in to Day28
dose-limiting toxicities
Incidence and severity of AEs
Time frame: from the time that the patient provides informed consent through and including 30 days after the last administration of ABSK141.
Adverse events
Incidence and severity of SAEs
Time frame: from the time that the patient provides informed consent through and including 30 days after the last administration of ABSK141.
serious adverse events
10 secondary outcomes
Cmax
Time frame: From pre-dose to up to 72 hours post-dose
AUC
Time frame: From pre-dose to up to 72 hours post-dose
t1/2
Time frame: From pre-dose to up to 72 hours post-dose
CL/F
Time frame: From pre-dose to up to 72 hours post-dose
tmax
Time frame: From pre-dose to up to 72 hours post-dose
ORR
Time frame: From the first dose date to the date of first confirmed response (CR/PR), assessed up to 24 months.
DOR
Time frame: From date of first confirmed response (CR/PR) to date of first documented progression (PD) or death from any cause, whichever comes first, assessed up to 24 months.
PFS
Time frame: From the first dose date to the date of first documented progressive disease (PD) or death from any cause, whichever occurs first, assessed up to 24 months.
DCR
Time frame: From the first dose date to the date of first documented disease status assessment (CR/PR/SD/PD), assessed up to 24 months.
OS
Time frame: From the first dose date to the date of death from any cause, assessed up to24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xianjun Yu, Doctor principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ABSK141-400mg, ABSK141-Recommended Dose for Expansion (RDE) and ABSK141-800mg in people with Solid Tumors, Adult, run by Abbisko Therapeutics Co, Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Zhang, Bachelor (+86-021-68912098, yuco.zhang@abbisko.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of DLTs (time frame: from Run-in to Day28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.