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

NCT ID: NCT07164170

Last Updated: 2025-09-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-25
• Study Completion Date: 2029-07-30

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 21-day combination cycle.

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 combination with Glecirasib, and the combination regimen recommended for the expansion part. The expansion part will further evaluate the safety, PK profile, and anti-tumor efficacy of ABSK043 in combination with Glecirasib at the one or more recommended dose (s).

Up to 86 patients with locally advanced or metastatic Non-small Cell Lung Cancer (NSCLC) are planned to be enrolled in the study.

• Escalation Part: up to 50 previously treated patients with KRASG12C mutation.
• Expansion Part: up to 36 treatment-naïve patients with KRASG12C mutation.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: ABSK043 in combination with Glecirasib

This is an open-label phase 2 study with an escalation part and an expansion part.

• Escalation Part: up to 50 previously treated patients with KRASG12C mutation. Does Escalation Cohort(Part A): up to 30previously treated patients with KRASG12C mutation.

Dose Confirmation Cohort(Part B): up to 20previously treated patients with KRASG12C mutation.

• Expansion Part: up to 36 treatment-naïve patients with KRASG12C mutation.

Group Type: EXPERIMENTAL

ABSK043 in combination with Glecirasib

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbisko Therapeutics Co, Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Guangxi Medical University Cancer Hospital & Guangxi Cancer Institude

Nanning, Guangxi, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Tongji Hospital Tongji Medical College of Hust

Wuhan, Hubei, China

Hunan Cancer Hospitial

Changsha, Hunan, China

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Central Hospital Affiliated to Shangdong First Medical University

Jinan, Shangdong, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

West China Hospital Sichuan University

Chengdu, Sichuan, China

Countries

China

Central Contacts

Yinan Lin

Role: CONTACT

clinical@abbisko.cn

+86-21-68910052

Facility Contacts

Jian Fang

Role: primary

Zhangzhou Huang

Role: primary

Meili Sun

Role: primary

Shun Lu

Role: primary

Chunxia Su

Role: primary

Yu Yao

Role: primary

Other Identifiers

ABSK043-201

Identifier Type: -

Identifier Source: org_study_id