Solid Tumor (Phase I)Phase 1NCT07718165
A Phase I Study of ABSK211 in Participants With Advanced Solid Tumors With KRAS Alteration
A Phase 1 study testing ABSK211 in people with Solid Tumor (Phase I), run by Abbisko Therapeutics Co, Ltd at 1 site in China.
Trial summary
This is a first-in-human (FIH), multicenter, open-label, phase I study of ABSK211 in participants with advanced solid tumors 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 Tumor (Phase I)
- What is being tested?
- ABSK211
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 247 participants
- Where
- 1 siteChina
- Study dates
- 28 Aug 2026to 30 Jun 2030
- 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
- Participants should understand, sign, and date the written informed consent form prior to screening.
- Male or female age 18 years or older
- Participants with histologically confirmed locally-advanced or metastatic solid tumors harboring KRAS alteration
- ECOG performance status 0 or 1
- Life expectancy ≥ 3 months
- Adequate organ function and bone marrow function
- For participants participating exploration of food effect:
- 1)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
- Participants who were previously treated with any inhibitors targeting specific KRAS alleles, pan-KRAS inhibitors, pan- or multi-RAS inhibitors, or any other treatments directly targeting RAS.
- Has a known additional malignancy that is progressing or has required active treatment
- Has swallowing dysfunction or malabsorption syndrome
- Previous anti-tumor therapy, including chemotherapy ,endocrine therapy, molecular targeted therapy or other investigational drugs received ≤2 weeks or ≤5-half life ,radiotherapy and antibody therapy received ≤4 weeks prior to initiation of study treatment.
- Major surgery within 4 weeks of the first dose of investigational product or with any unhealed surgical wounds, 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;
- Participants use proton pump inhibitors for at least 7 days prior to the first dose of ABSK211 and during treatment with ABSK211.
- P-gp inhibitor, moderate and strong CYP3A inhibitors to 7 days or 5 half-lives and for strong CYP3A inducers to 2 weeks or 5 half-lives ;
- Active central nervous system (CNS) metastases;
- History of interstitial lung disease (ILD) requiring systemic steroid treatment;
- Heart disease or medical history ;
- NSCLC cohorts: Participant previously identified as having a driver mutation and have not received any targeted therapy;
- Known acquired immunodeficiency syndrome (AIDS)-related illness, or positive test for HIV 1/2 antibody;
- Exclusion of hepatitis infection;
- Participants with refractory/uncontrolled ascites or pleural effusion;
- Pregnant or nursing (lactating) women;
- Partners of non-surgically sterilized male participants or female participants of childbearing potential who refuse to use effective methods of birth control during the study and for up to 6 months after the last dose of investigational product;
- Sexually active males who refuse to use a condom during medication period and until 3 months after stopping investigational product;
- Vaccination with a live, attenuated vaccine within 4 weeks prior to the first dose of study treatment except for administration of inactivate vaccines ;
- Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, or any other condition;
- -
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, Shanghai Municipality, 201321
xianjun Yu, Doctor, 13801669875, yuxianjun@fudanpci.org
About this study
Official title: A Phase I, Open-Label Study of ABSK211 to Assess Safety, Tolerability, Efficacy and Pharmacokinetics in Participants With Advanced Solid Tumors With KRAS Alteration
This is a first-in-human (FIH), multicenter, open-label, phase I study of ABSK211 in participants with advanced solid tumors to evaluate safety, tolerability, PK and optimize the dosage.
Read the detailed description
The study will start with a dose escalation of oral ABSK211 in participants with advanced solid tumors with KRAS alteration to evaluate safety, tolerability, and PK. The expansion part will evaluate the safety and efficacy of oral ABSK211 at the recommended doses for expansion (RDEs) in selected tumor types harboring KRAS alteration and further optimize the dosage.
- Conditions
- Solid Tumor (Phase I)
- Being tested
- ABSK211
- Keywords
- ABSK211, KRAS Alteration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABSK211Drug
During the escalation part ,all participants will firstly receive a single dose of ABSK211 as a run-in period to access the safety and PK of ABSK211. Then, participants will continuously receive ABSK211 once daily (QD), with each treatment cycle of 21 days； In the expansion part，participants will orally receive ABSK211 at the recommended dose for expansion (RDE).
| Study group | Role | What they receive |
|---|---|---|
| ABSK211 | Experimental | During the escalation part ,all participants will firstly receive a single dose of ABSK211 as a run-in period to access the safety and PK of ABSK211. Then, participants will continuously receive ABSK211 once daily (QD), with each treatment cycle of 21 days； In the expansion part，participants will orally receive ABSK211 at the recommended dose for expansion (RDE). Receives: Drug: ABSK211 |
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 Day21
AEs
Adverse events
Measured: The date of signing the informed consent form until 30 days (including Day 30) after the last administration of investigational product
SAEs
Serious adverse events (SAEs)
Measured: The date of signing the informed consent form until 30 days (including Day 30) after the last administration of investigational product
Secondary outcomes (13)
Cmax
maximum observed concentration
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
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
ORR
Objective response rate
Measured: throughout study completion, assessed up to 24 months
DOR
Duration of response
Measured: throughout study completion, assessed up to 24 months
DCR
Disease control rate
Measured: throughout study completion, assessed up to 24 months
PFS
Progression-free survival
Measured: throughout study completion, assessed up to 24 months
OS
Overall survival
Measured: throughout study completion, assessed up to 24 months
Vz/F
apparent volume of distribution
Measured: from pre-dose to up to 72 hours post-dose
AR
accumulation ratio
Measured: from pre-dose to up to 72 hours post-dose
BPR
Blood plasma ratio
Measured: from pre-dose to up to 72 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start28 Aug 2026
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor (Phase I)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
- 247 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
- NCT07718165
- Sponsor's protocol ID
- ABSK211-101
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 4 Sep 2026
- 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 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label Study of ABSK211 to Assess Safety, Tolerability, Efficacy and Pharmacokinetics in Participants With Advanced Solid Tumors With KRAS Alteration
- ClinicalTrials.gov ID
- NCT07718165
- Acronym / sponsor ID
- ABSK211-101
- Conditions
- Solid Tumor (Phase I)
- Keywords
- ABSK211, KRAS Alteration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 247 participants (estimated)
- Lead sponsor
- Abbisko Therapeutics Co, LtdIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2026 (actual)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 21 Jul 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), multicenter, open-label, phase I study of ABSK211 in participants with advanced solid tumors to evaluate safety, tolerability, PK and optimize the dosage.
Detailed description
The study will start with a dose escalation of oral ABSK211 in participants with advanced solid tumors with KRAS alteration to evaluate safety, tolerability, and PK. The expansion part will evaluate the safety and efficacy of oral ABSK211 at the recommended doses for expansion (RDEs) in selected tumor types harboring KRAS alteration and further optimize the dosage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABSK211 | Experimental | Drug: ABSK211During the escalation part ,all participants will firstly receive a single dose of ABSK211 as a run-in period to access the safety and PK of ABSK211. Then, participants will continuously receive ABSK211 once daily (QD), with each treatment cycle of 21 days； In the expansion part，participants will orally receive ABSK211 at the recommended dose for expansion (RDE). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants should understand, sign, and date the written informed consent form prior to screening.
- Male or female age 18 years or older
- Participants with histologically confirmed locally-advanced or metastatic solid tumors harboring KRAS alteration
- ECOG performance status 0 or 1
- Life expectancy ≥ 3 months
Key exclusion criteria (22 listed)
- Known allergy or hypersensitivity to any component of the investigational product
- Participants who were previously treated with any inhibitors targeting specific KRAS alleles, pan-KRAS inhibitors, pan- or multi-RAS inhibitors, or any other treatments directly targeting RAS.
- Has a known additional malignancy that is progressing or has required active treatment
- Has swallowing dysfunction or malabsorption syndrome
- Previous anti-tumor therapy, including chemotherapy ,endocrine therapy, molecular targeted therapy or other investigational drugs received ≤2 weeks or ≤5-half life ,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 |
|---|---|---|
| ABSK211During the escalation part ,all participants will firstly receive a single dose of ABSK211 as a run-in period to access the safety and PK of ABSK211. Then, participants will continuously receive ABSK211 once daily (QD), with each treatment cycle of 21 days； In the expansion part，participants will orally receive ABSK211 at the recommended dose for expansion (RDE). | Drug | ABSK211 |
Primary outcome
Incidence of DLTs
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 administration of investigational product
Adverse events
SAEs
Time frame: The date of signing the informed consent form until 30 days (including Day 30) after the last administration of investigational product
Serious adverse events (SAEs)
13 secondary outcomes
Cmax
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
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
ORR
Time frame: throughout study completion, assessed up to 24 months
DOR
Time frame: throughout study completion, assessed up to 24 months
DCR
Time frame: throughout study completion, assessed up to 24 months
PFS
Time frame: throughout study completion, assessed up to 24 months
OS
Time frame: throughout study completion, assessed up to 24 months
Vz/F
Time frame: from pre-dose to up to 72 hours post-dose
AR
Time frame: from pre-dose to up to 72 hours post-dose
BPR
Time frame: from pre-dose to up to 72 hours post-dose
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 4 Sep 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 study testing ABSK211 in people with Solid Tumor (Phase I), 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 8 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 4 Sep 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 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 Lijun Zheng, Master (+86-021-68912098, lijun.zheng@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 Day21). 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 4 Sep 2026.