Solid Tumors (Phase 1)Phase 1ABSK131-101NCT07288957
A Early Study of ABSK131 in Patients With Advanced/Metastatic Solid Tumors
A Phase 1 study testing ABSK131 in people with Solid Tumors (Phase 1), run by Abbisko Therapeutics Co, Ltd at 1 site in China.
Trial summary
This is a first-in-human (FIH), multicenter, non-randomized, openlabel, phase 1 study of ABSK131 in patients with MTAP-Deficient Advanced/Metastatic Solid Tumors to evaluate the safety, tolerability, PK, and preliminary antitumor efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors (Phase 1)
- What is being tested?
- ABSK131
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteChina
- Study dates
- 22 Jul 2025to 30 Jul 2029
- Phase
- Phase 1
- 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
- 1. Patients should understand, sign, and date the written informed consent form before screening.
- 2. Male or female aged 18 years or older.
- 3. Patients with histologically or cytologically confirmed metastatic or locally advanced solid tumor; have received and progressed, are refractory or are intolerant to standard therapy or lack of standard therapy for the particular tumor type.
- 4. Patients with homozygous deletion of MTAP gene based on central testing or sponsor-accepted local report (depending on the availability of regional genetic testing), or with MTAP expression loss in the tumor based on the central testing.
- 5. Patients should provide archival tumor sample or undergo tumor biopsy at baseline if archival sample is not available or inadequate.
- 6. Backfill cohorts and expansion cohorts: Patients with 1 of the following cancers and have received no more than 3 prior lines of therapy。1)NSCLC；2) Pancreatic cancer；3)Esophageal cancer；4)Gastric cancer；5)Mesotheliomas.
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- Food effect: a. Be able to eat a standardized high-fat meal within 30 minutes. b. Without primary GI tumors or metastasis.
- 7. Patients must have at least one measurable target lesion according to RECIST v1.1.
- 8. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- 9. Life expectancy ≥3 months.
- 10.Adequate organ function and bone marrow function as indicated by the screening assessments performed within 14 days prior to the first dose of study drug.
- 11.Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mmHg at screening and no change in antihypertensive medications within 1 week prior to the first dose.
- 12.Non-surgically sterilized male or female patients of childbearing potential must agree to use highly effective methods of birth control from signing the informed consent to approximately 6 months after the last dose of study drug. A condom is also required to be used by vasectomized men to prevent delivery of the drug via seminal fluid.
Who cannot join
- 1. Known allergy or hypersensitivity to any component of ABSK131.
- 2. Prior treatment with a PRMT5 or MAT2A inhibitor therapy.
- 3. Another active primary malignancy.
- 4. Unable to swallow capsules 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, or current evidence of GI disease that present with diarrhea. If any of these conditions exist, the sites' staff should discuss with the sponsor to determine patient eligibility.
- 5. Any of the situation within the specified time frame prior to the first administration of study drug.
- 6. Prior toxicities from chemotherapy, radiotherapy, and other anti-cancer therapies, including immunotherapy that have not regressed to Grade ≤ 1 severity (CTCAE v5.0) with the exception of which eligibility criteria allows, or alopecia, vitiligo, hypothyroidism stable on hormone replacement, or Grade 2 peripheral neurotoxicity.
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- 7. Potent strong inhibitors or inducers of CYP3A family within 2 weeks before the first dose of study treatment (3 weeks for St John's Wort); consumption of grapefruit juice, grapefruit hybrids, pomegranates, starfruits, pomelos, seville oranges or juice products within 3 days prior to the first dose of study treatment.
- 8. Proton pump inhibitors, such as omeprazole, lansoprazole, dexlansoprazole, or pantoprazole within 7 days before the first dose of study treatment.
- 9. Imaging (CT or MRI) showed tumor invasion of large blood vessels (such as aorta, pulmonary artery, pulmonary vein, vena cava, etc.) or risk of bleeding (such as esophageal and gastric varices).
- 10.Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging) or leptomeningeal disease (symptomatic or asymptomatic) or symptomatic unstable brain metastases. Patients with a history of brain metastases have been treated and are stable ≥ 28 days may be enrolled. Patients with no steroid use for at least 2 weeks prior to the time of enrollment are permitted.
- 11.Impaired cardiac function or clinically significant cardiac disease.
- 12.Known acquired immunodeficiency syndrome (AIDS)-related illness, or positive test for HIV 1/2 antibody.
- 13.Exclusion of hepatitis infection.
- 14.Patients with ascites or pleural effusion, or pericardial effusion which is refractory/uncontrolled, or requiring the intervention within 2 weeks prior to the first dose.
- 15.Confirmed or suspected ILD/pneumonitis or history of (non-infectious) ILD/pneumonitis that required oral or IV steroids or supplemental oxygen.
- 16.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test within 7 days prior to the start of study drug.
- 17.Vaccination with a live, attenuated vaccine within 4 weeks prior to the first dose of study treatment except for administration of inactivate vaccines .
- 18.Has had an allogenic tissue/solid organ transplant.
- 19.Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
- 20.Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, or any other condition, which in the judgment of investigators, could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the patient to safety risks.
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
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 201210
Shun Lu, Professor, 18017321551, shun_lu@hotmail.com
Ying Li, 17721015525, ying.li@abbisko.com
About this study
Official title: A Phase 1, First-in-Human, Multicenter, Open-Label Study of ABSK131 to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy in Patients With MTAP-Deficient Advanced/Metastatic Solid Tumors
This is a first-in-human (FIH), multicenter, non-randomized, openlabel, phase 1 study of ABSK131 in patients with MTAP-Deficient Advanced/Metastatic Solid Tumors to evaluate the safety, tolerability, PK, and preliminary antitumor efficacy.
Read the detailed description
The study will be started with a dose escalation part of ABSK131 administered in repeated 21-day cycles in patients with MTAP-Deficient Advanced/Metastatic Solid Tumors. The expansion part of oral ABSK131 at the recommended dose of expansion (RDE) will be followed to evaluate safety, tolerability, and preliminary antitumor activity among patients with MTAP-Deficient Advanced/Metastatic Solid Tumors.
- Conditions
- Solid Tumors (Phase 1)
- Being tested
- ABSK131
- Keywords
- ABSK131, MTAP, PRMT5
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABSK131Drug
In the escalation part，patients will first orally receive a single dose of ABSK131 on D-2, followed by a two-day run-in period to assess the PK profile of single-dose ABSK131 administration. Thereafter, patients will continuously receive ABSK131 once daily (QD).
In the expansion part， patients will orally receive ABSK131 at the recommended dose for expansion (RDE)
| Study group | Role | What they receive |
|---|---|---|
| Escalation and expansion part | Experimental | No more than 86 patients are anticipated to be enrolled in the escalation part. No more than 180 patients will be enrolled in the expansion part Receives: Drug: ABSK131 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of DLT
Dose-limiting toxicities
Measured: from Run-in to Day21
AEs
Adverse events
Measured: The date of signing the informed consent form until 30 days (including Day 30) after the last dose of study drug, assessed up to 30 months.
AESIs
Adverse events of special interest (AESIs)
Measured: he date of signing the informed consent form until 30 days (including Day 30) after the last dose of study drug, assessed up to 30 months.
SAEs
Serious adverse events (SAEs)
Measured: The date of signing the informed consent form until 30 days (including Day 30) after the last dose of study drug, assessed up to 30 months
Secondary outcomes (10)
Cmax
Maximum observed concentration
Measured: From date of enrollment（Run-） until the date of end of treatment visit, assessed up to 30 months
AUC
area under the concentration-time curve
Measured: From date of enrollment（R） until the date of end of treatment visit, assessed up to 30 months
t1/2
elimination half-life
Measured: From date of enrollment（Run-in） until the date of end of treatment visit, assessed up to 30 months
CL/F
apparent oral clearance
Measured: From date of enrollment（Run-in） until the date of end of treatment visit, assessed up to 30 months
tmax
time to maximum observed concentration
Measured: From date of enrollment（R） until the date of end of treatment visit, assessed up to 30 months
ORR
Objective response rate
Measured: From date of enrollment（R）until the date of disease progression, start of new anticancer treatment, death, withdrawal of consent of study, lost to follow up or end of study, whichever comes first，assessed up to 30 months
DOR
Duration of response
Measured: From date of enrollment（R）until the date of disease progression, start of new anticancer treatment, death, withdrawal of consent of study, lost to follow up or end of study, whichever comes first，assessed up to 30 months
PFS
Progression-free survival
Measured: From date of enrollment（R）until the date of disease progression, start of new anticancer treatment, death, withdrawal of consent of study, lost to follow up or end of study, whichever comes first，assessed up to 30 months
DCR
Disease control rate
Measured: From date of enrollment（R）until the date of disease progression, start of new anticancer treatment, death, withdrawal of consent of study, lost to follow up or end of study, whichever comes first，assessed up to 30 months
OS
Overall survival
Measured: From date of enrollment（Run-in）until the date of death, withdrawal of consent of study, lost to follow up or end of study, whichever comes first，assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start22 Jul 2025
- 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 (Phase 1)Studies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 266 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbisko Therapeutics Co, Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288957
- Sponsor's protocol ID
- ABSK131-101
- Acronym
- ABSK131-101
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human, Multicenter, Open-Label Study of ABSK131 to Assess Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy in Patients With MTAP-Deficient Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT07288957
- Acronym / sponsor ID
- ABSK131-101 / ABSK131-101
- Conditions
- Solid Tumors (Phase 1)
- Keywords
- ABSK131, MTAP, PRMT5
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 266 participants (estimated)
- Lead sponsor
- Abbisko Therapeutics Co, LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 17 Dec 2025 (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), multicenter, non-randomized, openlabel, phase 1 study of ABSK131 in patients with MTAP-Deficient Advanced/Metastatic Solid Tumors to evaluate the safety, tolerability, PK, and preliminary antitumor efficacy.
Detailed description
The study will be started with a dose escalation part of ABSK131 administered in repeated 21-day cycles in patients with MTAP-Deficient Advanced/Metastatic Solid Tumors. The expansion part of oral ABSK131 at the recommended dose of expansion (RDE) will be followed to evaluate safety, tolerability, and preliminary antitumor activity among patients with MTAP-Deficient Advanced/Metastatic Solid Tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Escalation and expansion part | Experimental | Drug: ABSK131No more than 86 patients are anticipated to be enrolled in the escalation part. No more than 180 patients will be enrolled in the expansion part |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 1. Patients should understand, sign, and date the written informed consent form before screening.
- 2. Male or female aged 18 years or older.
- 3. Patients with histologically or cytologically confirmed metastatic or locally advanced solid tumor; have received and progressed, are refractory or are intolerant to standard therapy or lack of standard therapy for the particular tumor type.
- 4. Patients with homozygous deletion of MTAP gene based on central testing or sponsor-accepted local report (depending on the availability of regional genetic testing), or with MTAP expression loss in the tumor based on the central testing.
- 5. Patients should provide archival tumor sample or undergo tumor biopsy at baseline if archival sample is not available or inadequate.
Key exclusion criteria (20 listed)
- 1. Known allergy or hypersensitivity to any component of ABSK131.
- 2. Prior treatment with a PRMT5 or MAT2A inhibitor therapy.
- 3. Another active primary malignancy.
- 4. Unable to swallow capsules 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, or current evidence of GI disease that present with diarrhea. If any of these conditions exist, the sites' staff should discuss with the sponsor to determine patient eligibility.
- 5. Any of the situation within the specified time frame prior to the first administration of study drug.
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 |
|---|---|---|
| ABSK131In the escalation part，patients will first orally receive a single dose of ABSK131 on D-2, followed by a two-day run-in period to assess the PK profile of single-dose ABSK131 administration. Thereafter, patients will continuously receive ABSK131 once daily (QD). In the expansion part， patients will orally receive ABSK131 at the recommended dose for expansion (RDE) | Drug | Escalation and expansion part |
Primary outcome
Incidence of DLT
Time frame: from Run-in to Day21
Dose-limiting toxicities
AEs
Time frame: The date of signing the informed consent form until 30 days (including Day 30) after the last dose of study drug, assessed up to 30 months.
Adverse events
AESIs
Time frame: he date of signing the informed consent form until 30 days (including Day 30) after the last dose of study drug, assessed up to 30 months.
Adverse events of special interest (AESIs)
SAEs
Time frame: The date of signing the informed consent form until 30 days (including Day 30) after the last dose of study drug, assessed up to 30 months
Serious adverse events (SAEs)
10 secondary outcomes
Cmax
Time frame: From date of enrollment（Run-） until the date of end of treatment visit, assessed up to 30 months
AUC
Time frame: From date of enrollment（R） until the date of end of treatment visit, assessed up to 30 months
t1/2
Time frame: From date of enrollment（Run-in） until the date of end of treatment visit, assessed up to 30 months
CL/F
Time frame: From date of enrollment（Run-in） until the date of end of treatment visit, assessed up to 30 months
tmax
Time frame: From date of enrollment（R） until the date of end of treatment visit, assessed up to 30 months
ORR
Time frame: From date of enrollment（R）until the date of disease progression, start of new anticancer treatment, death, withdrawal of consent of study, lost to follow up or end of study, whichever comes first，assessed up to 30 months
DOR
Time frame: From date of enrollment（R）until the date of disease progression, start of new anticancer treatment, death, withdrawal of consent of study, lost to follow up or end of study, whichever comes first，assessed up to 30 months
PFS
Time frame: From date of enrollment（R）until the date of disease progression, start of new anticancer treatment, death, withdrawal of consent of study, lost to follow up or end of study, whichever comes first，assessed up to 30 months
DCR
Time frame: From date of enrollment（R）until the date of disease progression, start of new anticancer treatment, death, withdrawal of consent of study, lost to follow up or end of study, whichever comes first，assessed up to 30 months
OS
Time frame: From date of enrollment（Run-in）until the date of death, withdrawal of consent of study, lost to follow up or end of study, whichever comes first，assessed up to 60 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 17 Dec 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABSK131 in people with Solid Tumors (Phase 1), 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 13 inclusion and 20 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 17 Dec 2025. 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 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.
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 Ying Li (+86-21-68910052, ying.li@abbisko.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of DLT (time frame: from Run-in to Day21). The study lists 4 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 17 Dec 2025.