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

NCT06668103 | Recruiting Phase 2

• 1 other identifier: ABSK043-202
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Non-Small Cell Lung Cancer With EGFR Mutation

Outcome Measures

Primary Outcomes (5)

• Incidence of DLT

  Dose-limiting toxicities

  At the end of Cycle 1 (each cycle is 21 days)

• AEs

  Adverse events

  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 furmonertinib mesylate, whichever occurs first, up to 30 months.

• SAEs

  Serious adverse events (SAEs)

  From the time patients sign 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 furmonertinib mesylate, whichever occurs first, up to 30 months.

• AESIs

  Adverse events of special interest (AESIs)

  From the time patients sign 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 furmonertinib mesylate, whichever occurs first, up to 30 months.

• PFS rate at 12 month

  Progression-free survival at 12 month

  From the time patients receive the first dose of study drug to 12 months，assessed up to 30 months.

Secondary Outcomes (16)

• Cmax

  From the date of enrolment #Cycle1 Day1# to #Cycle7#, and for patients who discontinue treatment before cycle 7 (C7), PK sampling will be performed at the EOT visit and assessed up to 10 months.

• AUC

  From the date of enrolment #Cycle1 Day1# to #Cycle7#, and for patients who discontinue treatment before cycle 7 (C7), PK sampling will be performed at the EOT visit and assessed up to 10 months.

• t1/2

  From the date of enrolment #Cycle1 Day1# to #Cycle7#, and for patients who discontinue treatment before cycle 7 (C7), PK sampling will be performed at the EOT visit and assessed up to 10 months.

• Vz/F

  From the date of enrolment #Cycle1 Day1# to #Cycle7#, and for patients who discontinue treatment before cycle 7 (C7), PK sampling will be performed at the EOT visit and assessed up to 10 months.

• CL/F

  From the date of enrolment #Cycle1 Day1# to #Cycle7#, and for patients who discontinue treatment before cycle 7 (C7), PK sampling will be performed at the EOT visit and assessed up to 10 months.

Study Arms (1)

ABSK043 in combination with Firmonertinib

EXPERIMENTAL

This is an open-label phase 2 study with an escalation part and an expansion part. * Escalation part: Previously treated patients with EGFR Mutated NSCLC will be enrolled. * Dose escalation cohort: up to 12 patients; * Dose confirmation cohort: at least 3 patients, and up to 12 patients. * Expansion part: * Dose expansion cohort: up to 30 treatment-naïve patients with EGFR Mutated NSCLC are expected to be enrolled.

Drug: ABSK043 in combination with Firmonertinib

Interventions

ABSK043 in combination with Firmonertinib DRUG

Two potential dose levels ：400 mg twice daily （BID） and 800 mg BID) of ABSK043 are prespecified and firmonertinib will be administered orally at a fixed dose of 80 mg once daily (QD). Patients in dose escalation cohort will receive the ABSK043, 400 mg BID and firmonertinib 80 mg QD as the starting dose for the combination therapy. Patients in dose confirmation cohort and dose expansion cohort will receive the recommended dose in dose escalation cohort and be evaluated for safety and preliminary anti-tumor activity of the combination therapy. After Cycle 1, 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.

ABSK043 in combination with Firmonertinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)
• 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:

• \. 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.

Sponsors & Collaborators

• Abbisko Therapeutics Co, Ltd: lead

Study Sites (5)

Hanhui Cancer Hospital

Hefei, Anhui, China

NOT YET RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

NOT YET RECRUITING

Union Hospital Tongji Medical College Huzhong University of Science and Techology

Wuhan, Hubei, China

NOT YET RECRUITING

Jilin Cancer Hospital

Changchun, Jilin, China

NOT YET RECRUITING

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Central Study Contacts

Yuan Lu

CONTACT

+86-21-68910052; clinical@abbisko.cn

Yinan Lin

CONTACT

+86-21-68910052; yinan.lin@abbisko.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: October 31, 2024
• Study Start: November 25, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: December 12, 2024

Record last verified: 2024-10

Locations

CN (5)