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A Phase 2 Study of ABSK043 Combined With Osimertinib

14. juli 2026 opdateret af: 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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

72

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: ABSK043 in combination with Osimertinib
This is an open-label phase 2 study with an escalation part and an expansion part.
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
- Incidence of dose-limiting toxicity (DLT)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Maximum observed concentration（Cmax）
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: From treatment start up to 5 years
Escalation Part
From treatment start up to 5 years
Objective response rate (ORR)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Abbisko Therapeutics Co, Ltd

Samarbejdspartnere

AstraZeneca

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

31. august 2026

Primær færdiggørelse (Anslået)

31. december 2029

Studieafslutning (Anslået)

31. december 2030

Datoer for studieregistrering

Først indsendt

14. juli 2026

Først indsendt, der opfyldte QC-kriterier

14. juli 2026

Først opslået (Faktiske)

17. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ABSK043-203

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