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Non-Small Cell Lung CancerPhase 2NCT07164170

A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Glecirasib

A Phase 2 study testing ABSK043 in combination with Glecirasib in people with Non-Small Cell Lung Cancer, run by Abbisko Therapeutics Co, Ltd at 17 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a multicenter, open-label phase 2 study that will enroll KRASG12C mutated patients with locally advanced or metastatic NSCLC, receiving treatment (ABSK043 in combination with Glecirasib) in a 21-day combination cycle. 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?
ABSK043 in combination with Glecirasib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
17 sitesChina
Study dates
22 Sep 2025to 30 Jul 2029
Phase
Phase 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

  • Prior to any protocol- specific procedures are performed, the patient should understand and voluntarily sign and date the written informed consent form.
  • Gender was not limited patients aged ≥18 years at the time of signing the informed consent.
  • Histologically or cytologically confirmed locally advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC).
  • For patients in the dose-escalation cohort (Part A) of the escalation part:
  • Patients must have experienced disease progression following at least one line of prior standard systemic therapy, but no more than two lines of systemic therapy.
  • For patients in the dose confirmation cohort (Part B) of the escalation part :
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  • Prior treatment requirements for patients in cohort (Part B) are the same as those for patients in (Part A);
  • Documented or central laboratory test report confirmed that the tumor was PD-L1 expression positive (≥1%) .
  • For patients in the expansion cohort of the expansion part :
  • Patients who have not received prior systemic therapy for locally advanced or unresectable/metastatic disease;
  • Central laboratory test report confirmed that the tumor was PD-L1 expression positive (≥1%) .
  • Tumor tissue or blood test report confirmed KRASG12C mutation.
  • Patients must have at least one measurable lesion as defined by RECIST v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0~1.
  • Expected survival time of ≥3 months.
  • Patients must have adequate organ and bone marrow function.

Who cannot join

  • Histological or cytological evidence of small cell lung cancer or neuroendocrine carcinoma components.
  • Toxicities from prior antitumor therapy have not returned to baseline or stabilized.
  • Patients with active brain metastases.
  • The patient currently has active interstitial lung disease.
  • Patients currently have active autoimmune disease or a history of autoimmune disease that may be at risk for recurrence.
  • Any condition requiring systemic treatment with corticosteroids.
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  • Uncontrolled or significant cardiovascular disease.
  • Has a known human immunodeficiency virus (HIV) infection that is not well controlled.
  • Any evidence of severe or uncontrolled diseases or other factors which in the Investigator's opinion makes it undesirable for the patients to participate in the study

Trial locations and contacts

17 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yinan Lin contact

+86-21-68910052

clinical@abbisko.cn

17 sites in 1 country

China17 sites, 17 recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality

    Jian Fang

    Jian Fang

    Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality

    Jianchun Duan

    Jianchun Duan

    Not yet recruiting

  • Hunan Cancer Hospitial

    Changsha, Hunan

    Yongchang Zhang

    Yongchang Zhang

    Recruiting

  • West China Hospital Sichuan University

    Chengdu, Sichuan

    Guowei Che

    Guowei Che

    Recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian

    Zhangzhou Huang

    Zhangzhou Huang

    Recruiting

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong

    Kejing Tang

    Tang Tang

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

    Lihua Shang

    Lihua Shang

    Recruiting

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

    Yiruo Zhang

    Yiruo Zhang

    Not yet recruiting

  • Central Hospital Affiliated to Shangdong First Medical University

    Jinan, Shangdong

    Meili Sun

    Meili Sun

    Not yet recruiting

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu

    Shuhua Han

    Shuhua Han

    Recruiting

  • Guangxi Medical University Cancer Hospital & Guangxi Cancer Institude

    Nanning, Guangxi

    Shaozhang Zhou

    Shaozhang Zhou

    Not yet recruiting

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality

    Shun Lu

    Shun Lu

    Recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality

    Chunxia Su

    Chunxia Su

    Recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning

    Mingfang Zhao

    Mingfang Zhao

    Recruiting

  • Tongji Hospital Tongji Medical College of Hust

    Wuhan, Hubei

    Qian Chu

    Qian Chu

    Not yet recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi

    Yu Yao

    Yu Yao

    Not yet recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan

    Qiming Wang

    Qiming Wang

    Not yet recruiting

Other trials in China

About this study

Official title: An Open-label Phase II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of ABSK043 in Combination With Glecirasib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring a KRAS G12C Mutation

This is a multicenter, open-label phase 2 study that will enroll KRASG12C mutated patients with locally advanced or metastatic NSCLC, receiving treatment (ABSK043 in combination with Glecirasib) in a 21-day combination cycle.

Read the detailed description

The study consists of an escalation part and an expansion part. The escalation part will evaluate the safety, tolerability, preliminary efficacy, and PK profile of different doses of ABSK043 in combination with Glecirasib, and the combination regimen recommended for the expansion part. The expansion part will further evaluate the safety, PK profile, and anti-tumor efficacy of ABSK043 in combination with Glecirasib at the one or more recommended dose (s).

Up to 86 patients with locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) are planned to be enrolled in the study.

  • Escalation Part: up to 50 previously treated patients with KRASG12C mutation.
  • Expansion Part: up to 36 treatment-naïve patients with KRASG12C mutation.
Being tested
ABSK043 in combination with Glecirasib
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.

  • ABSK043 in combination with GlecirasibDrug

    Dose escalation cohort( Part A) ABSK043 150 mg BID in combination with Glecirasib 200 mg QD will be selected as the starting dose.

    Based on the accumulated safety data and PK profile, the Safety Review Committee (SRC), composed of the investigator and the sponsor, may discuss and agree to allow exploration of other possible doses.

    Dose confirmation cohort (Part B) and Expansion cohort Patients in dose confirmation cohort and expansion cohort will receive the recommended dose in dose escalation cohort and be evaluated for safety and preliminary anti-tumor activity.

    All patients will continue to receive combination therapy every 21 days until disease progression, death, loss to follow-up, withdrawal of consent, intolerable toxicity, investigator decision to discontinue treatment, or end of the study.

Study groups in NCT07164170
Study groupRoleWhat they receive
Experimental: ABSK043 in combination with GlecirasibExperimentalThis is an open-label phase 2 study with an escalation part and an expansion part. • Escalation Part: up to 50 previously treated patients with KRASG12C mutation. Does Escalation Cohort(Part A): up to 30previously treated patients with KRASG12C mutation. Dose Confirmation Cohort(Part B): up to 20previously treated patients with KRASG12C mutation. • Expansion Part: up to 36 treatment-naïve patients with KRASG12C mutation.
Receives: Drug: ABSK043 in combination with Glecirasib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of DLT

    Dose-limiting toxicities

    Measured: At the end of Cycle 1 (each cycle is 21 days)

  2. AEs

    Adverse events

    Measured: From the time the patient signs the informed consent form throughout the study and up to 90 days after the last dose of ABSK043 or 30 days after the last dose of Glecirasib, whichever occurs first, up to 30 months.

  3. SAEs

    Serious adverse events (SAEs)

    Measured: From the time the patient signs the informed consent form throughout the study and up to 90 days after the last dose of ABSK043 or 30 days after the last dose of Glecirasib, whichever occurs first, up to 30 months.

  4. AESIs AESIs

    Adverse events of special interest (AESIs)

    Measured: From the time the patient signs the informed consent form throughout the study and up to 90 days after the last dose of ABSK043 or 30 days after the last dose of Glecirasib, whichever occurs first, up to 30 months.

  5. ORR

    objective response rate

    Measured: From date of enrolment#Cycle1 Day1# until disease progression, death, loss to follow-up, withdrawal of consent, intolerable toxicity, investigator's decision to discontinue treatment, or end of study, whichever comes first, assessed up to 50 months.

Secondary outcomes (15)

  1. Cmax

    Maximum observed concentration

    Measured: From the date of enrolment #Cycle1 Day1# to #Cycle7#, and for patients who discontinue treatment before cycle 7 (C7), PK sampling will be performed at the EOT visit and assessed up to 10 months

  2. AUC

    area under the concentration-time curve

    Measured: From the date of enrolment #Cycle1 Day1# to #Cycle7#, and for patients who discontinue treatment before cycle 7 (C7), PK sampling will be performed at the EOT visit and assessed up to 10 months.

  3. t1/2 t1/2

    elimination half-life

    Measured: From the date of enrolment #Cycle1 Day1# to #Cycle7#, and for patients who discontinue treatment before cycle 7 (C7), PK sampling will be performed at the EOT visit and assessed up to 10 months.

  4. Vz/F

    apparent volume of distribution

    Measured: From the date of enrolment #Cycle1 Day1# to #Cycle7#, and for patients who discontinue treatment before cycle 7 (C7), PK sampling will be performed at the EOT visit and assessed up to 10 months.

  5. CL/F

    apparent oral clearance

    Measured: From the date of enrolment #Cycle1 Day1# to #Cycle7#, and for patients who discontinue treatment before cycle 7 (C7), PK sampling will be performed at the EOT visit and assessed up to 10 months.

  6. Cmax,ss

    maximum observed concentration after multiple doses maximum observed concentration after multiple doses maximum observed concentration after multiple doses

    Measured: From the date of enrolment #Cycle1 Day1# to #Cycle7#, and for patients who discontinue treatment before cycle 7 (C7), PK sampling will be performed at the EOT visit and assessed up to 10 months.

  7. Cmin,ss

    minimum observed concentration after multiple doses

    Measured: From the date of enrolment #Cycle1 Day1# to #Cycle7#, and for patients who discontinue treatment before cycle 7 (C7), PK sampling will be performed at the EOT visit and assessed up to 10 months.

  8. AUCtau,ss

    area under the concentration-time curve after multiple doses

    Measured: From the date of enrolment #Cycle1 Day1# to #Cycle7#, and for patients who discontinue treatment before cycle 7 (C7), PK sampling will be performed at the EOT visit and assessed up to 10 months.

  9. AR

    accumulation ratio

    Measured: From the date of enrolment #Cycle1 Day1# to #Cycle7#, and for patients who discontinue treatment before cycle 7 (C7), PK sampling will be performed at the EOT visit and assessed up to 10 months.

  10. tmax

    time to maximum observed concentration

    Measured: From the date of enrolment #Cycle1 Day1# to #Cycle7#, and for patients who discontinue treatment before cycle 7 (C7), PK sampling will be performed at the EOT visit and assessed up to 10 months.

  11. DOR DOR

    Duration of response

    Measured: From date of enrolment#Cycle1 Day1# until disease progression, death, loss to follow-up, withdrawal of consent, intolerable toxicity, investigator's decision to discontinue treatment, or end of study, whichever comes first, assessed up to 50 months.

  12. PFS

    Progression-free survival

    Measured: From date of enrolment#Cycle1 Day1# until disease progression, death, loss to follow-up, withdrawal of consent, intolerable toxicity, investigator's decision to discontinue treatment, or end of study, whichever comes first, assessed up to 50 months.

  13. DCR

    Disease control rate

    Measured: From date of enrolment#Cycle1 Day1# until disease progression, death, loss to follow-up, withdrawal of consent, intolerable toxicity, investigator's decision to discontinue treatment, or end of study, whichever comes first, assessed up to 50 months.

  14. TTP

    Time to progression

    Measured: From date of enrolment #Cycle1 Day1# until disease progression, assessed up to 50 months.

  15. OS

    Overall survival Overall survival Overall survival

    Measured: From date of enrolment#Cycle1 Day1# until disease progression, death, loss to follow-up, withdrawal of consent, intolerable toxicity, investigator's decision to discontinue treatment, or end of study, whichever comes first, assessed up to 50 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2025
  2. Study start22 Sep 2025
  3. Primary completion30 Dec 2028 (estimated)
  4. Study completion30 Jul 2029 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single Group Assignment
Masking
None (open label)
Enrolment
86 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07164170
Sponsor's protocol ID
ABSK043-201
Status last verified
Sep 2025
First submitted
2 Sep 2025
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ABSK043 in combination with Glecirasib in people with Non-Small Cell Lung Cancer, run by Abbisko Therapeutics Co, Ltd at 17 sites 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 16 inclusion and 9 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 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites 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 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 Yinan Lin (+86-21-68910052, clinical@abbisko.cn), 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: At the end of Cycle 1 (each cycle is 21 days)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07164170.

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 Jun 2026.

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