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

Recruiting now · Phase 2

Conditions studied: Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT07164170

Run by

Abbisko Therapeutics Co, Ltd

People needed

86

Starts

2025-09-22

Expected to finish

2029-07-30

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Zhongda Hospital Southeast University — Nanjing, Jiangsu, China (enrolling)
• The First Hospital of China Medical University — Shenyang, Liaoning, China (enrolling)
• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (enrolling)
• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (enrolling)
• Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (enrolling)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (enrolling)
• West China Hospital Sichuan University — Chengdu, Sichuan, China (enrolling)
• Fujian Cancer Hospital — Fuzhou, Fujian, China (enrolling)
• The First Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (enrolling)
• Hunan Cancer Hospitial — Changsha, Hunan, China (enrolling)
• Tongji Hospital Tongji Medical College of Hust — Wuhan, Hubei, China
• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China
• Guangxi Medical University Cancer Hospital & Guangxi Cancer Institude — Nanning, Guangxi, China
• Henan Cancer Hospital — Zhengzhou, Henan, China
• The First Affiliated Hospital of Anhui Medical University — Hefei, Anhui, China
• Central Hospital Affiliated to Shangdong First Medical University — Jinan, Shangdong, China
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi’an, Shanxi, China

Full record on ClinicalTrials.gov

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