A Phase 2 Clinical Study of Combination Therapy With ABSK043 and Firmonertinib
NCT ID: NCT06668103
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
54 participants
INTERVENTIONAL
2024-11-25
2028-06-30
Brief Summary
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Detailed Description
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Dose escalation:
• Post-line: Patients with locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation with tumor progression after treatment with systemic treatment
Dose Expansion:
• First-Line: Patients with locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation, and without prior systemic therapy for advanced or metastatic disease.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ABSK043 in combination with Firmonertinib
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.
ABSK043 in combination with Firmonertinib
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.
Interventions
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ABSK043 in combination with Firmonertinib
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.
Eligibility Criteria
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Inclusion Criteria
2. At least 1 measurable lesion as assessed by Investigator as per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
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
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.
18 Years
ALL
No
Sponsors
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Abbisko Therapeutics Co, Ltd
INDUSTRY
Responsible Party
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Locations
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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
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Yueyin Pan
Role: primary
Yan Yu
Role: primary
Xiaorong Dong
Role: primary
Ying Cheng
Role: primary
Shun Lu
Role: primary
Other Identifiers
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ABSK043-202
Identifier Type: -
Identifier Source: org_study_id