A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Glecirasib
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
Abbisko Therapeutics Co, Ltd
86 participants
Sep 22, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria16
- 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.
Exclusion Criteria9
- 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.
- 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
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Interventions
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.
Locations(17)
View Full Details on ClinicalTrials.gov
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NCT07164170