Status:
NOT_YET_RECRUITING
A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Glecirasib
Lead Sponsor:
Abbisko Therapeutics Co, Ltd
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
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 combin...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2029
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT07164170
Start Date
October 25 2025
End Date
July 30 2029
Last Update
September 10 2025
Active Locations (17)
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1
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
2
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
3
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
4
Fujian Cancer Hospital
Fuzhou, Fujian, China