Non-Small Cell Lung CancerPhase 1NCT06225804
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK112 in Patients With Non-Small Cell Lung Cancer
A Phase 1 study testing ABSK112 in people with Non-Small Cell Lung Cancer, run by Abbisko Therapeutics Co, Ltd at 14 sites in 2 countries.
Trial summary
This is a first-in-human (FIH), multicenter, non-randomized, openlabel, phase 1 study of ABSK112 in patients with NSCLC 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
- Non-Small Cell Lung Cancer
- What is being tested?
- ABSK112
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 14 sitesin 2 countries
- Study dates
- 22 Feb 2024to Mar 2028
- 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
- Patients should understand, sign, and date the written informed consent form prior to screening.
- Male or female aged 18 years or older.
- Patients with histologically or cytologically confirmed locally advanced (and not a candidate for definitive therapy) or metastatic NSCLC.
- Cohort-specific inclusion criteria:
- For the escalation part (except for the RDE confirmation part), patients have progressed on, rejected, or are intolerant of standard therapy, or for whom no standard therapy exists
- For RDE confirmation in the escalation part: same as Cohort 1 in the expansion part
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- For the expansion part, patients have documented EGFR in-frame exon 20 insertion mutations confirmed by certificated local laboratories; and must also meet all criteria for the cohort in which their entry is proposed.
- Patients must have at least one measurable target lesion according to RECIST v1.1
- ECOG performance status 0 or 1
- 7. Life expectancy ≥3 months
- Adequate organ function and bone marrow function.
- Electrolyte: magnesium within 0.85 to 1.25 × institutional normal limits, sodium ≥130 mmol/L, potassium within institutional normal limits
- 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 Cycle1 Day1.
- For patients participating in food effect exploration part:
- Be able to eat a standardized high-fat meal within 30 minutes
- Be able to fast for 10 hours.
- Non-surgically sterilized male or female patients of childbearing potential must agree to use highly effective methods of birth control during the study treatment and for 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
- Known allergy or hypersensitivity to any component of the investigational product.
- NSCLC patients with EGFR Cys797Ser (C797S) mutation.
- Cohort-specific exclusion criteria.
- Have been diagnosed with another primary malignancy other than NSCLC except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.
- 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.
- Previous anti-cancer therapy, including chemotherapy, radiotherapy, molecular targeted therapy, antibody therapy or other investigational drugs received ≤4 weeks prior to initiation of study treatment.
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- Major surgery within 4 weeks prior to the first dose of study drug. Or any surgical wound is infected, dehisced, or not completely healed before the screening.
- 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.
- Note: Refer to inclusion criteria regarding hypertension.
- Potent moderate and 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.
- Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging) or leptomeningeal disease (symptomatic or asymptomatic).
- Impaired cardiac function or clinically significant cardiac disease.
- Known acquired immunodeficiency syndrome (AIDS)-related illness, or positive test for HIV 1/2 antibody.
- Exclusion of hepatitis infection based on the following results and/or criteria:
- Active hepatitis B infection: positive tests for hepatitis B surface antigen (HbsAg), or antibody to hepatitis B core antigen (anti-HBc). A patient with positive tests for HbsAg or anti-HBc but with HBV-DNA measurements lower than detectable can be enrolled.
- Active hepatitis C infection: positive Hepatitis C virus antibody. If positive antibody to hepatitis C Virus (anti-HCV) is detected, Hepatitis C virus RNA by polymerase chain reaction (PCR) is necessary. A patient with positive anti-HCV but with a negative test for HCV RNA can be enrolled.
- 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.
- Current evidence of radiation pneumonitis that required steroid treatment or unresolved drug-related pneumonitis, or current evidence or history of interstitial lung disease (ILD).
- 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.
- Vaccination with a live, attenuated vaccine within 4 weeks prior to the first dose of study treatment except for administration of inactivate vaccines (e.g., COVID-19 vaccines, inactivated influenza vaccines).
- Current evidence or previous history of corneal pathology such as keratopathy, corneal abrasion or ulceration, or any other abnormal changes that may increase the risk of corneal toxicity during the study treatment
- 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.
- Planned major surgery during study treatment.
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
China13 sites
Jilin Cancer Hospital
Changchun, Jilin
Hunan Cancer Hospital
Changsha, Hunan
Sichuan Cancer Hospital
Chengdu, Sichuan
Fujian Cancer Hospital
Fuzhou, Fujian
Zhejiang Caner Hospital
Hangzhou, Zhejiang
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
Anhui Chest Hospital
Hefei, Anhui
Central Hospital Affiliated to Shangdong of First Medical University
Jinan, Shandong
The first Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
Union Hospital Tongji Medical College Huzhong University of Science and Techology
Wuhan, Hubei
The first Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Harbin
Henan Cancer Hospital
Zhengzhou, Henan
United States1 site
Precision NextGen Oncology
Beverly Hills, California, 90212
About this study
Official title: A Phase 1, Open-Label Study of ABSK112 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Non-Small Cell Lung Cancer
This is a first-in-human (FIH), multicenter, non-randomized, openlabel, phase 1 study of ABSK112 in patients with NSCLC 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 ABSK112 administered in repeated 28-day cycles in patients with NSCLC. The expansion part of oral ABSK112 at the recommended dose of expansion (RDE) will be followed to evaluate safety, tolerability, and preliminary antitumor activity among patients with locally advanced or metastatic NSCLC harboring EGFR Exon20ins.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- ABSK112
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABSK112Drug
Also called EGFR Exon20 inhibitor
In the escalation part, patients will receive a single dose of oral ABSK112 on Cycle1 Day1 only, and then patients will continuously receive ABSK112 once daily (QD) or twice daily (BID) in subsequent cycles. In the expansion part, patients will each be treated at the selected RDE dose level.
| Study group | Role | What they receive |
|---|---|---|
| ABSK112 | Experimental | During the escalation part, the administration of oral ABSK112 will be guided by Bayesian optimal interval (BOIN) design based on safety data collected until a maximum tolerated dose (MTD) has been identified. The first dose level will be administered as QD, and different dosing frequencies (e.g., BID) may be explored in subsequent doses depending on emerging safety and pharmacokinetic data.
A separate food effect cohort may be conducted.
In expansion part, patients will be treated at the selected RDE dose level. Receives: Drug: ABSK112 |
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 Day1 to Day28
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 50 months.
AESIs
Adverse events of special interest (AESIs)
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 50 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 50 months.
Secondary outcomes (15)
Cmax
Maximum observed concentration
Measured: From date of enrollment（Day1） until the date of end of treatment visit, assessed up to 50 months
AUC
area under the concentration-time curve
Measured: From date of enrollment（Day1） until the date of end of treatment visit, assessed up to 50 months
t1/2
elimination half-life
Measured: From date of enrollment（Day1） until the date of end of treatment visit, assessed up to 50 months
Vz/F
apparent volume of distribution
Measured: From date of enrollment（Day1） until the date of end of treatment visit, assessed up to 50 months
CL/F
apparent oral clearance
Measured: From date of enrollment（Day1） until the date of end of treatment visit, assessed up to 50 months
Cmax,ss
maximum observed concentration after multiple doses
Measured: From date of enrollment（Day1） until the date of end of treatment visit, assessed up to 50 months
Cmin,ss
minimum observed concentration after multiple doses
Measured: From date of enrollment（Day1）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 50 months.
AUCtau,ss
area under the concentration-time curve after multiple doses
Measured: From date of enrollment（Day1）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 50 months.
AR
accumulation ratio
Measured: From date of enrollment（Day1）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 50 months.
tmax
time to maximum observed concentration
Measured: From date of enrollment（Day1）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 50 months.
ORR
Objective response rate
Measured: From date of enrollment（Day1）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 50 months.
DOR
Duration of response
Measured: From date of enrollment（Day1）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 50 months.
PFS
Progression-free survival
Measured: From date of enrollment（Day1）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 50 months.
DCR
Disease control rate
Measured: From date of enrollment（Day1）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 50 months.
OS
Overall survival
Measured: From date of enrollment（Day1）until the date of death, withdrawal of consent of study, lost to follow up or end of study, whichever comes first，assessed up to 100 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start22 Feb 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies 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
- 164 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
- NCT06225804
- Sponsor's protocol ID
- ABSK112-101
- Status last verified
- Oct 2026
- First submitted
- 4 Jan 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study of ABSK112 to Assess Safety, Tolerability, and Pharmacokinetics in Patients With Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06225804
- Acronym / sponsor ID
- ABSK112-101
- Conditions
- Non-Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Abbisko Therapeutics Co, LtdIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 26 Jan 2024 (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 ABSK112 in patients with NSCLC to evaluate the safety, tolerability, PK, and preliminary antitumor efficacy.
Detailed description
The study will be started with a dose escalation part of ABSK112 administered in repeated 28-day cycles in patients with NSCLC. The expansion part of oral ABSK112 at the recommended dose of expansion (RDE) will be followed to evaluate safety, tolerability, and preliminary antitumor activity among patients with locally advanced or metastatic NSCLC harboring EGFR Exon20ins.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABSK112 | Experimental | Drug: ABSK112During the escalation part, the administration of oral ABSK112 will be guided by Bayesian optimal interval (BOIN) design based on safety data collected until a maximum tolerated dose (MTD) has been identified. The first dose level will be administered as QD, and different dosing frequencies (e.g., BID) may be explored in subsequent doses depending on emerging safety and pharmacokinetic data. A separate food effect cohort may be conducted. In expansion part, patients will be treated at the selected RDE dose level. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Patients should understand, sign, and date the written informed consent form prior to screening.
- Male or female aged 18 years or older.
- Patients with histologically or cytologically confirmed locally advanced (and not a candidate for definitive therapy) or metastatic NSCLC.
- Cohort-specific inclusion criteria:
- Patients must have at least one measurable target lesion according to RECIST v1.1
Key exclusion criteria (23 listed)
- Known allergy or hypersensitivity to any component of the investigational product.
- NSCLC patients with EGFR Cys797Ser (C797S) mutation.
- Cohort-specific exclusion criteria.
- Have been diagnosed with another primary malignancy other than NSCLC except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.
- 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.
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 |
|---|---|---|
| ABSK112Also: EGFR Exon20 inhibitorIn the escalation part, patients will receive a single dose of oral ABSK112 on Cycle1 Day1 only, and then patients will continuously receive ABSK112 once daily (QD) or twice daily (BID) in subsequent cycles. In the expansion part, patients will each be treated at the selected RDE dose level. | Drug | ABSK112 |
Primary outcome
Incidence of DLT
Time frame: from Day1 to Day28
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 50 months.
Adverse events
AESIs
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 50 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 50 months.
Serious adverse events (SAEs)
15 secondary outcomes
Cmax
Time frame: From date of enrollment（Day1） until the date of end of treatment visit, assessed up to 50 months
AUC
Time frame: From date of enrollment（Day1） until the date of end of treatment visit, assessed up to 50 months
t1/2
Time frame: From date of enrollment（Day1） until the date of end of treatment visit, assessed up to 50 months
Vz/F
Time frame: From date of enrollment（Day1） until the date of end of treatment visit, assessed up to 50 months
CL/F
Time frame: From date of enrollment（Day1） until the date of end of treatment visit, assessed up to 50 months
Cmax,ss
Time frame: From date of enrollment（Day1） until the date of end of treatment visit, assessed up to 50 months
Cmin,ss
Time frame: From date of enrollment（Day1）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 50 months.
AUCtau,ss
Time frame: From date of enrollment（Day1）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 50 months.
AR
Time frame: From date of enrollment（Day1）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 50 months.
tmax
Time frame: From date of enrollment（Day1）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 50 months.
ORR
Time frame: From date of enrollment（Day1）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 50 months.
DOR
Time frame: From date of enrollment（Day1）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 50 months.
PFS
Time frame: From date of enrollment（Day1）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 50 months.
DCR
Time frame: From date of enrollment（Day1）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 50 months.
OS
Time frame: From date of enrollment（Day1）until the date of death, withdrawal of consent of study, lost to follow up or end of study, whichever comes first，assessed up to 100 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 26 Oct 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABSK112 in people with Non-Small Cell Lung Cancer, run by Abbisko Therapeutics Co, Ltd at 14 sites in 2 countries.
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 17 inclusion and 23 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: under way, not looking for participants, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China, United States. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of DLT (time frame: from Day1 to Day28). 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 26 Oct 2026.