Taking people in ChinaPhase 2
Tests ABSK043 with glecirasib in lung cancer with a KRAS G12C mutation
Tests two drugs together in adults with advanced lung cancer carrying a KRAS G12C mutation.
Key facts
- Who runs it
- Abbisko Therapeutics Co, Ltd
- Where
- Beijing, Changsha, Chengdu, Fuzhou, Guangzhou, Harbin, Hefei, Jinan, Nanjing, Nanning, Shanghai, Shenyang, Wuhan, Xi’an, and Zhengzhou, ChinaSee the 17 sites
- Trial code
- Registry title
- A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Glecirasib
- Status
- Recruiting
- Phase
- Phase 2
- People taking part
- 86 people, planned
- Started
- 22 Sept 2025
- Expected to end
- 30 Jul 2029
- Type of study
- Interventional
- Treatments tested
- ABSK043 in combination with Glecirasib
- Record updated
- 17 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic non-small cell lung cancer that has a KRAS G12C mutation. They will receive ABSK043 together with glecirasib.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Non-small cell lung cancer that is locally advanced and cannot be removed by surgery, or has spread (metastatic). It must be measurable by RECIST v1.1, with ECOG performance status 0 to 1 and expected survival of at least 3 months.
- Earlier treatment
- Dose-escalation cohort (Part A) and dose-confirmation cohort (Part B): disease progressed after at least one but no more than two lines of standard systemic therapy. Expansion cohort: no earlier systemic therapy for advanced or metastatic disease.
- Biomarker or test result
- KRAS G12C mutation confirmed by a tumor tissue or blood test. Part B and the expansion cohort also need a tumor that is PD-L1 positive (≥1%).
Main reasons for not taking part
- Small cell lung cancer or neuroendocrine carcinoma components
- Active brain metastases
- Active interstitial lung disease
- Active autoimmune disease, or past autoimmune disease that may come back
- HIV infection that is not well controlled
The registry criteria, word for word
Show all 17 criteriaShow less
Who can take part
- 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 :; 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 take part
- Toxicities from prior antitumor therapy have not returned to baseline or stabilized
- Any condition requiring systemic treatment with corticosteroids
- Histological or cytological evidence of small cell lung cancer or neuroendocrine carcinoma components
- 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
- 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
- Patients with active brain metastases
Where in China
- Beijing Cancer HospitalBeijing, ChinaContact: Jian FangTaking people
- Cancer Hospital, Chinese Academy of Medical SciencesBeijing, ChinaContact: Jianchun DuanNot yet recruiting
- Hunan Cancer HospitialChangsha, ChinaContact: Yongchang ZhangTaking people
- West China Hospital，Sichuan UniversityChengdu, ChinaContact: Guowei CheTaking people
- Fujian Cancer HospitalFuzhou, ChinaContact: Zhangzhou HuangTaking people
- the First Affiliated Hospital of Sun Yat-sen UniversityGuangzhou, ChinaContact: Kejing TangTaking people
- Harbin Medical University Cancer HospitalHarbin, ChinaContact: Lihua ShangTaking people
- The First Affiliated Hospital of Anhui Medical UniversityHefei, ChinaContact: Yiruo ZhangNot yet recruiting
- Central Hospital Affiliated to Shangdong First Medical UniversityJinan, ChinaContact: Meili SunNot yet recruiting
- Zhongda Hospital Southeast UniversityNanjing, ChinaContact: Shuhua HanTaking people
- Guangxi Medical University Cancer Hospital & Guangxi Cancer InstitudeNanning, ChinaContact: Shaozhang ZhouNot yet recruiting
- Shanghai Chest HospitalShanghai, ChinaContact: Shun LuTaking people
- Shanghai Pulmonary HospitalShanghai, ChinaContact: Chunxia SuTaking people
- The First Hospital of China Medical UniversityShenyang, ChinaContact: Mingfang ZhaoTaking people
- Tongji Hospital Tongji Medical College of HustWuhan, ChinaContact: Qian ChuNot yet recruiting
- The First Affiliated Hospital of Xi'an Jiaotong UniversityXi’an, ChinaContact: Yu YaoNot yet recruiting
- Henan Cancer HospitalZhengzhou, ChinaContact: Qiming WangNot yet recruiting
About the trial
What the trial wants to find out
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.
The group in the trial
- Experimental: ABSK043 in combination with GlecirasibTreatment being tested
This 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.
Treatment: ABSK043 in combination with Glecirasib
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Tests ABSK043 with glecirasib in lung cancer with a KRAS G12C mutationGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 17 June 2026