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

Recruiting now · Phase 2

Conditions studied: Non-Small Cell Lung Cancer With EGFR Mutation

In brief

This is an open-label phase 2 study to evaluate the safety, tolerability and preliminary anti-tumour activity of ABSK043 in combination with Firmonertinib in patients with Epidermal Growth Factor Receptor-mutated (EGFRm+) locally advanced or metastatic NSCLC.

Key facts

Study ID

NCT06668103

Run by

Abbisko Therapeutics Co, Ltd

People needed

54

Starts

2024-11-25

Expected to finish

2028-06-30

Last updated by the study team

2024-12-12

Who can join

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

You may qualify if…

• Histologically or cytologically documented locally advanced or metastatic NSCLC
• At least 1 measurable lesion as assessed by Investigator as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
• Inclusion Criteria Specific to Dose Escalation cohort and Dose Confirmation Cohort：Must has disease progression following treatment with EGFR-TKI in the locally advanced or metastatic setting for locally advanced or metastatic disease Documentation of PDL1 expression positive (TPS/TC≥1%)detected from tumor tissue Inclusion Criteria Specific to Dose expansion Cohort： Must not have received any other prior systemic cancer therapies in the locally advanced/metastatic setting PDL1 expression positive (TPS/TC≥1%) as assessed by central laboratory from tumor tissue
• Adequate bone marrow reserve and organ function based on local laboratory data .
• Documented genetic testing reports confirmed the presence of EGFR L858R or EGFR exon 19 del mutations in tumor or plasma ctDNA.

You may not qualify if…

• 1. Histological or cytological examinations suggest that NSCLC squamous cells is the predominant histology, or contains small cell lung cancer, neuroendocrine carcinoma, etc.
• Has a history of interstitial lung disease (ILD)/pneumonitis or active ILD
• Has spinal cord compression or clinically active central nervous system metastases, defined as symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with clinically inactive brain metastases may be included in the study
• Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0, Grade ≤1 or baseline.
• Is receiving chronic systemic corticosteroids dosed at >10 mg prednisone or equivalent anti-inflammatory activity or any form of immunosuppressive therapy.
• 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

• Shanghai Chest Hospital — Shanghai, Shanghai Municipality, China (enrolling)
• Hanhui Cancer Hospital — Hefei, Anhui, China
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China
• Union Hospital Tongji Medical College Huzhong University of Science and Techology — Wuhan, Hubei, China
• Jilin Cancer Hospital — Changchun, Jilin, China

Full record on ClinicalTrials.gov

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