ABSK043 in combination with Glecirasib: 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.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Incidence of DLT — At the end of Cycle 1 (each cycle is 21 days) Dose-limiting toxicities
AEs — From the time the patient signs the informed consent form throughout the study and up to 90 days after the last dose of ABSK043 or 30 days after the last dose of Glecirasib, whichever occurs first, up to 30 months. Adverse events
SAEs — From the time the patient signs the informed consent form throughout the study and up to 90 days after the last dose of ABSK043 or 30 days after the last dose of Glecirasib, whichever occurs first, up to 30 months. Serious adverse events (SAEs)
AESIs AESIs — From the time the patient signs the informed consent form throughout the study and up to 90 days after the last dose of ABSK043 or 30 days after the last dose of Glecirasib, whichever occurs first, up to 30 months. Adverse events of special interest (AESIs)
ORR — From date of enrolment#Cycle1 Day1# until disease progression, death, loss to follow-up, withdrawal of consent, intolerable toxicity, investigator's decision to discontinue treatment, or end of study, whichever comes first, assessed up to 50 months. objective response rate
Trial sites (17)
Facility
City
Region
Status
The First Affiliated Hospital of Anhui Medical University
Hefei
Anhui
Not Yet Recruiting
Beijing Cancer Hospital
Beijing
Beijing Municipality
Recruiting
Cancer Hospital Chinese Academy of Medical Sciences
Beijing
Beijing Municipality
Not Yet Recruiting
Fujian Cancer Hospital
Fuzhou
Fujian
Recruiting
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou
Guangdong
Recruiting
Guangxi Medical University Cancer Hospital & Guangxi Cancer Institude
Nanning
Guangxi
Not Yet Recruiting
Harbin Medical University Cancer Hospital
Harbin
Heilongjiang
Recruiting
Henan Cancer Hospital
Zhengzhou
Henan
Not Yet Recruiting
Tongji Hospital Tongji Medical College of Hust
Wuhan
Hubei
Not Yet Recruiting
Hunan Cancer Hospitial
Changsha
Hunan
Recruiting
Zhongda Hospital Southeast University
Nanjing
Jiangsu
Recruiting
The First Hospital of China Medical University
Shenyang
Liaoning
Recruiting
Central Hospital Affiliated to Shangdong First Medical University
Jinan
Shangdong
Not Yet Recruiting
Shanghai Chest Hospital
Shanghai
Shanghai Municipality
Recruiting
Shanghai Pulmonary Hospital
Shanghai
Shanghai Municipality
Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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