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

Launched by ABBISKO THERAPEUTICS CO, LTD · Oct 30, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment approach for patients with non-small cell lung cancer (NSCLC) that has a specific mutation in the Epidermal Growth Factor Receptor (EGFR). The study is looking at the safety and effectiveness of two medications, ABSK043 and Firmonertinib, when used together. It's currently open for enrollment, meaning they are looking for participants who meet certain criteria.

To be eligible, participants must have confirmed locally advanced or metastatic NSCLC and at least one area of cancer that can be measured. They should also have genetic testing showing specific mutations related to EGFR and must have experienced disease progression after previous treatments. Participants can expect to undergo tests and evaluations to monitor their health throughout the study. It’s important to note that people with certain other health issues or specific types of lung cancer may not be able to join the trial. Overall, this study aims to find better treatment options for patients with this type of lung cancer.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Histologically or cytologically documented locally advanced or metastatic NSCLC
• • 2. At least 1 measurable lesion as assessed by Investigator as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
• • 3. 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
• • 4. Adequate bone marrow reserve and organ function based on local laboratory data .
• • 5. Documented genetic testing reports confirmed the presence of EGFR L858R or EGFR exon 19 del mutations in tumor or plasma ctDNA.
• Exclusion Criteria:
• • 1. 1. Histological or cytological examinations suggest that NSCLC squamous cells is the predominant histology, or contains small cell lung cancer, neuroendocrine carcinoma, etc.
• • 2. Has a history of interstitial lung disease (ILD)/pneumonitis or active ILD
• • 3. 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
• • 4. 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.
• • 5. Is receiving chronic systemic corticosteroids dosed at \>10 mg prednisone or equivalent anti-inflammatory activity or any form of immunosuppressive therapy.
• • 6. Uncontrolled or significant cardiovascular disease
• • 7. Has a known human immunodeficiency virus (HIV) infection that is not well controlled.
• • 8. 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.