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A Phase 2 Study of ABSK043 Combined With Osimertinib

14 juillet 2026 mis à jour par: 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

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

72

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: ABSK043 in combination with Osimertinib
This is an open-label phase 2 study with an escalation part and an expansion part.
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
- Incidence of dose-limiting toxicity (DLT)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Maximum observed concentration（Cmax）
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: From treatment start up to 5 years
Escalation Part
From treatment start up to 5 years
Objective response rate (ORR)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Abbisko Therapeutics Co, Ltd

Collaborateurs

AstraZeneca

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

31 août 2026

Achèvement primaire (Estimé)

31 décembre 2029

Achèvement de l'étude (Estimé)

31 décembre 2030

Dates d'inscription aux études

Première soumission

14 juillet 2026

Première soumission répondant aux critères de contrôle qualité

14 juillet 2026

Première publication (Réel)

17 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

17 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • ABSK043-203

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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