A Phase 2 Study of ABSK043 Combined With Osimertinib

Phase 2Not Yet RecruitingNCT07710612

Abbisko Therapeutics Co, Ltd72 enrolled

Overview

This is a phase 2, open-Label study to evaluate the efficacy and safety of ABSK043 Combined with Osimertinib in participants with EGFR-Mutated locally advanced or metastatic Non-Small Cell Lung Cancer

This is an open-label study with an escalation part and an expansion part. The dose escalation part will evaluate the safety, tolerability of ABSK043 in combination with Osimertinib in previously treated participants with EGFR-mutated and PD-L1 positive locally advanced or metastatic NSCLC. The expansion part will evaluate the efficacy of ABSK043 in combination with Osimertinib as first-line treatment for participants with EGFR-mutated and PD-L1 positive locally advanced or metastatic NSCLC at the one or more recommended dose(s). The safety, tolerability, and PK profile of ABSK043 in combination with Osimertinib will also be further evaluated. Escalation Part: The escalation part includes dose escalation cohorts and backfill cohort(s), enrolling a sufficient number with previously treated participants with EGFR-mutated and PD-L1 positive locally advanced or metastatic NSCLC. Expansion Part: The expansion part will enroll a sufficient number with treatment-naïve participants with locally advanced or metastatic NSCLC harboring the EGFR mutation and PD-L1 positive expression.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Small Cell Lung Cancer With EGFR-mutated and PD-L1 Positive

Interventions

ABSK043 in combination with OsimertinibDRUG

Three potential dose levels of ABSK043 are prespecified, and Osimertinib will be administered orally at a fixed dose of 80 mg QD in escalation cohort. 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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria： 1. Aged 18 or above, male or female. 2. Participants must understand and voluntarily participate in this study and must have been provided informed consent for study participation. 3. NSNLC confirmed by tissue or cytological pathology. NSCLC with a mixed histology is eligible, if adenocarcinoma is the predominant histology. 4. Diagnosed locally advanced or metastatic NSCLC 5. Different requirements for specific cohort: Dose escalation and backfill cohorts: 1. Participants with disease in the adjuvant setting, post chemoradiotherapy setting, locally advanced stage or metastatic stage, who have received at least one prior line of third-generation EGFR-TKI-based monotherapy or combination therapy and experienced disease progression. 2. Participants must have received ≥2 prior lines of frontline systemic therapy. 3. Documented or central laboratory test report confirms that the tumor is PD-L1 expression positive (TPS/TC≥1%). 4. Documented genetic testing report confirms the presence of EGFR alteration(s) in tumor or plasma. Expansion cohort(s): 1. Participants must not have received any other prior systemic cancer therapies in the locally advanced/metastatic setting for locally advanced or metastatic disease. 2. Central laboratory test report confirms that the tumor is PD-L1 expression positive (TPS/TC≥1%). 3. Documented genetic testing reports confirm the presence of EGFR 6. Presence of at least one measurable tumor lesion 7. ECOG score 0-1 at screening. 8. The expected life expectancy after the first dose is \>12 weeks. Exclusion Criteria: * 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. Spinal cord compression and unstable brain metastases. 4.Any unresolved toxicities from prior systemic therapy greater than CTCAE v6.0 Grade 1 at the time of starting study treatment. 5\. Participants with obvious and unstable pleural effusion, peritoneal effusion or pericardial effusion . 6\. Has a history of other malignant tumors, or currently have other malignant tumors. 7\. Participants with known HIV infection.

Locations (7)

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Outcomes

Primary Outcomes

- Incidence of dose-limiting toxicity (DLT)

Escalation Part

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

Adverse events(AEs)

Escalation Part

Time frame: From the time the patient signs the informed consent form throughout the study and up to 30 days (± 7 days) after the last dose of ABSK043 or Osimertinib, up to 30 months.

Serious adverse events (SAEs)

Escalation Part

Time frame: From the time the patient signs the informed consent form throughout the study and up to 30 days (± 7 days) after the last dose of ABSK043 or Osimertinib, up to 30 months.

Adverse events of special interest (AESIs)

Escalation Part

Time frame: From the time the patient signs the informed consent form throughout the study and up to 30 days (± 7 days) after the last dose of ABSK043 or Osimertinib, up to 30 months.

Progression-free survival at 12 month

Expansion Part

Time frame: From the time patients receive the first dose of study drug to 12 months，assessed up to 5 years.

Secondary Outcomes

Maximum observed concentration（Cmax）

Escalation Part

Time frame: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.

Area under the concentration-time curve area under the concentration-time curve area under the concentration-time curve (AUC)

Escalation Part

Time frame: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.

Central Contacts

Zan Chen

CONTACT

+8613816094024 zan.chen@abbisko.com

Data from ClinicalTrials.gov

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