Combination therapy with ABSK043 and Glecirasib in KRASG12C-mutated NSCLC

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label phase 2 study enrolling adults with KRASG12C-mutated NSCLC that is locally advanced or metastatic. The study uses a dose-escalation part to identify a safe and potentially effective dosing of ABSK043 in combination with Glecirasib, followed by an expansion part to further assess safety and anti-tumor activity at the recommended dose(s). Up to 86 participants will be enrolled, including both previously treated and treatment-naïve patients. The trial will evaluate safety, pharmacokinetics, and preliminary efficacy of the drug combination in two cohorts and in an expanded cohort for treatment-naïve patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Prior to any protocol- specific procedures are performed, the patient should understand and voluntarily sign and date the written informed consent form.
2. Gender was not limited patients aged ≥18 years at the time of signing the informed consent.
3. 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 :
   1. Prior treatment requirements for patients in cohort (Part B) are the same as those for patients in (Part A);
   2. 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 :
   1. Patients who have not received prior systemic therapy for locally advanced or unresectable/metastatic disease;
   2. Central laboratory test report confirmed that the tumor was PD-L1 expression positive (≥1%) .
4. Tumor tissue or blood test report confirmed KRASG12C mutation.
5. Patients must have at least one measurable lesion as defined by RECIST v1.1.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0\~1.
7. Expected survival time of ≥3 months.
8. Patients must have adequate organ and bone marrow function.

Exclusion Criteria:

1. Histological or cytological evidence of small cell lung cancer or neuroendocrine carcinoma components.
2. Toxicities from prior antitumor therapy have not returned to baseline or stabilized.
3. Patients with active brain metastases.
4. The patient currently has active interstitial lung disease.
5. Patients currently have active autoimmune disease or a history of autoimmune disease that may be at risk for recurrence.
6. Any condition requiring systemic treatment with corticosteroids.
7. Uncontrolled or significant cardiovascular disease.
8. Has a known human immunodeficiency virus (HIV) infection that is not well controlled.
9. 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's running

• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting
• Fujian Cancer Hospital
  Fuzhou, Fujian, China Recruiting
• The First Affiliated Hospital of Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting
• Harbin Medical University Cancer Hospital
  Harbin, Heilongjiang, China Recruiting
• Hunan Cancer Hospitial
  Changsha, Hunan, China Recruiting
• Zhongda Hospital Southeast University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Yinan Lin
• Email: clinical@abbisko.cn
• Phone: +86-21-68910052

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.