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A Phase 2 Study of ABSK043 Combined With Osimertinib

2026년 7월 14일 업데이트: Abbisko Therapeutics Co, Ltd

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 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

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

72

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 중국
      • Hangzhou, 중국
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • 수석 연구원:
          • Jianying Zhou, Doctor
        • 연락하다:
          • Jianying Zhou, Doctor
          • 전화번호: +86571-87236876
          • 이메일: drzjy@163.com
    • Guangdong
      • Guangzhou, Guangdong, 중국
        • The First Affiliated Hospital, Sun Yat-sen University
        • 연락하다:
        • 수석 연구원:
          • Kejing Tang, Doctor
    • Heilongjiang
      • Harbin, Heilongjiang, 중국
        • Harbin Medical University Cancer Hospital
        • 연락하다:
          • Yanbin Zhao, Doctor
          • 전화번호: +8613904811741 +86451-86298000
          • 이메일: zhaoyb_gcp@126.com
        • 수석 연구원:
          • Yanbin Zhao, Doctor
    • Hubei
      • Wuhan, Hubei, 중국, 430022
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • 수석 연구원:
          • Xiaorong Dong, Doctor
        • 연락하다:
          • Xiaorong Dong, Doctor
          • 전화번호: +8613986252286 +8627-85728022
          • 이메일: xhzzdxr@126.com
    • Liaoning
      • Shenyang, Liaoning, 중국, 110001
        • The First Hospital of China Medical University
        • 연락하다:
          • Mingfang Zhao, Doctor
          • 전화번호: +8613644055129 +8624-83282888
          • 이메일: zhaomf618@126.com
        • 수석 연구원:
          • Mingfang Zhao, Doctor
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, 중국
        • Shanghai Chest Hospital
        • 수석 연구원:
          • Shun Lu, Doctor
        • 연락하다:
    • Shanxi
      • Taiyuan, Shanxi, 중국, 030013
        • Shanxi Provincial Cancer Hospital
        • 연락하다:
        • 수석 연구원:
          • Wei Guo, Doctor

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: ABSK043 in combination with Osimertinib
This is an open-label phase 2 study with an escalation part and an expansion part.
의약품: ABSK043 in combination with Osimertinib

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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
- Incidence of dose-limiting toxicity (DLT)
기간: At the end of Cycle 1 (each cycle is 21 days)
Escalation Part
At the end of Cycle 1 (each cycle is 21 days)
Adverse events(AEs)
기간: 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.
Escalation Part
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)
기간: 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.
Escalation Part
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)
기간: 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.
Escalation Part
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
기간: From the time patients receive the first dose of study drug to 12 months，assessed up to 5 years.
Expansion Part
From the time patients receive the first dose of study drug to 12 months，assessed up to 5 years.

2차 결과 측정

결과 측정
측정값 설명
기간
Maximum observed concentration（Cmax）
기간: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Escalation Part
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)
기간: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Escalation Part
From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Elimination half-life(t1/2)
기간: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Escalation Part
From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Apparent volume of distribution(Vz/F)
기간: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Escalation Part
From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Apparent oral clearance(CL/F)
기간: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Escalation Part
From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Maximum observed concentration after multiple doses(Cmax,ss)
기간: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Escalation Part
From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Minimum observed concentration after multiple doses(Cmin,ss)
기간: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Escalation Part
From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Area under the concentration-time curve after multiple doses(AUCtau,ss)
기간: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Escalation Part
From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Accumulation ratio(AR)
기간: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Escalation Part
From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Time to maximum observed concentration(tmax)
기간: From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Escalation Part
From the date of enrolment #Cycle1 Day1 to EOT visit and assessed up to 10 months.
Progression-Free Survival (PFS)
기간: From treatment start up to 5 years
Escalation Part
From treatment start up to 5 years
Objective response rate (ORR)
기간: From treatment start up to 5 years
Defined as the proportion of participants achieving confirmed complete response (CR) or partial response (PR), as assessed by the investigator according to RECIST v1.1.
From treatment start up to 5 years
Duration of response (DOR)
기간: From treatment start up to 5 years
Defined as the time (months) from the first documented objective response to the investigator-assessed radiographic disease progression (PD) according to RECIST v1.1 or death from any cause, whichever occurs first.
From treatment start up to 5 years
Disease control rate (DCR)
기간: From treatment start up to 5 years
Defined as the proportion of participants achieving confirmed complete remission (CR) or partial remission (PR), or stable disease (SD), as assessed by the investigator according to RECIST v1.1.
From treatment start up to 5 years
Time to progression (TTP)
기간: From treatment start up to 5 years
Defined as the time (months) from the first dose of study drug until the onset of radiographic disease progression (PD) as assessed by the investigator according to RECIST v1.1.
From treatment start up to 5 years
Overall survival (OS)
기간: From treatment start up to 7 years
Defined as the time (months) from the first administration of study drug to death due to any cause.
From treatment start up to 7 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Abbisko Therapeutics Co, Ltd

협력자

AstraZeneca

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 8월 31일

기본 완료 (추정된)

2029년 12월 31일

연구 완료 (추정된)

2030년 12월 31일

연구 등록 날짜

최초 제출

2026년 7월 14일

QC 기준을 충족하는 최초 제출

2026년 7월 14일

처음 게시됨 (실제)

2026년 7월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 14일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • ABSK043-203

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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