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Une étude du BH-30643 chez des sujets atteints d'un CPNPC localement avancé ou métastatique hébergeant des mutations EGFR et/ou HER2 (SOLARA)

2 novembre 2026 mis à jour par: BlossomHill Therapeutics

Une étude de phase 1/2 ouverte, multicentrique, première chez l'homme sur l'innocuité, la tolérance, la pharmacocinétique et l'activité antitumorale du BH-30643 chez des sujets atteints d'un CPNPC localement avancé ou métastatique hébergeant des mutations EGFR et/ou HER2 (SOLARA)

This Phase1/2, open label, multicenter study will assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics and preliminary anti-tumor activity of BH-30643 in patients with NSCLC having EGFR and/or HER2 mutations.

Phase 1 will determine the recommended Phase 2 dose (RP2D) and, if applicable, the maximum tolerated dose (MTD) of BH-30643, both as a monotherapy and in combination with chemotherapy.

Phase 2 will further evaluate the antitumor efficacy and safety in specified cohorts determined by EGFR/HER2 mutation subtypes and/or treatment history at the RP2D, as well as the population PK.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Description détaillée

BH-30643 is a novel, orally available, non-covalent, macrocyclic, mutant selective OMNI-EGFR inhibitor that targets a broad diversity of mutations in the EGFR kinase domain. These include EGFR classical mutations (e.g., ex19del and L858R) as well as less common (atypical) mutations (including G719X, S768I, L861Q, E709X, and beyond). BH-30643 also overcomes a variety of mutations which can cause resistance to previously approved EGFR TKIs (including both C797S and T790M). BH-30643 was designed to be selective over wildtype EGFR and HER2.

Type d'étude

Interventionnel

Inscription (Estimé)

675

Phase

  • Phase 2
  • La phase 1

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

  • Australie
    • Victoria
      • Heidelberg, Victoria, Australie, 3084
        • Recrutement
        • Austin Health
      • Melbourne, Victoria, Australie, 3000
        • Recrutement
        • Peter MacCallum Cancer Centre
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G1Z2
        • Recrutement
        • Cross Cancer Institute
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Recrutement
        • Princess Margaret Cancer Centre
  • Corée du Sud
      • Seoul, Corée du Sud, 05505
        • Recrutement
        • Asan Medical Center
      • Seoul, Corée du Sud, 03080
        • Recrutement
        • Seoul National University Hospital
      • Seoul, Corée du Sud, 06351
        • Recrutement
        • Samsung Medical Center
  • Hong Kong
      • Hong Kong, Hong Kong
        • Recrutement
        • Queen Mary Hospital
    • New Territories
      • Shatin, New Territories, Hong Kong
        • Recrutement
        • Prince of Wales Hospital
  • Japon
    • Chiba
      • Kashiwa, Chiba, Japon, 227-8577
        • Recrutement
        • National Cancer Center Hospital East
    • Osaka
      • Osakasayama-shi, Osaka, Japon
        • Recrutement
        • Kindai University Hospital
    • Tokyo
      • Tsukiji, Tokyo, Japon
        • Recrutement
        • National Cancer Center Hospital
  • Malaisie
    • Sarawak
      • Kuching, Sarawak, Malaisie, 93586
        • Recrutement
        • Sarawak General Hospital
  • Singapour
      • Kent Ridge, Singapour, 119074
        • Recrutement
        • National University Hospital
      • Singapore, Singapour, 168583
        • Recrutement
        • National Cancer Centre - Singapore
  • Taïwan
      • Taichung, Taïwan, 407219
        • Recrutement
        • Taichung Veterans General Hospital
      • Taipei, Taïwan
        • Recrutement
        • National Taiwan University Hospital
      • Taipei, Taïwan
        • Recrutement
        • National Taiwan University Cancer Center
  • États-Unis
    • Arizona
      • Phoenix, Arizona, États-Unis, 85054
        • Recrutement
        • Mayo Clinic Hospital - Arizona
    • California
      • Irvine, California, États-Unis, 92697
        • Recrutement
        • The Regents of the University of California - Irvine, CA Campus
      • La Jolla, California, États-Unis, 92093
        • Recrutement
        • UC San Diego Moores Cancer Center
      • Los Angeles, California, États-Unis, 90048
        • Recrutement
        • Cedars-Sinai Cancer at Cedars Sinai Medical Center
      • Sacramento, California, États-Unis, 95817
        • Recrutement
        • University of California, Davis Comprehensive Cancer Center
      • Stanford, California, États-Unis, 94305
        • Recrutement
        • Stanford University Medical Center
    • Connecticut
      • New Haven, Connecticut, États-Unis, 06520
        • Recrutement
        • Yale University - Cancer Center
    • District of Columbia
      • Washington D.C., District of Columbia, États-Unis, 20007
        • Recrutement
        • Georgetown University Medical Center
    • Florida
      • Jacksonville, Florida, États-Unis, 32224
        • Recrutement
        • Mayo Clinic - Florida
      • Orlando, Florida, États-Unis, 32827
        • Recrutement
        • Sarah Cancer Research Institution - Florida Cancer Specialist
      • Tampa, Florida, États-Unis, 33612
        • Recrutement
        • Moffitt Cancer Center
    • Illinois
      • Chicago, Illinois, États-Unis, 60611
        • Recrutement
        • Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion
    • Massachusetts
      • Boston, Massachusetts, États-Unis, 02215
        • Recrutement
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, États-Unis, 02215
        • Recrutement
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, États-Unis, 02214
        • Recrutement
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, États-Unis, 48202
        • Recrutement
        • Henry Ford Health
    • Minnesota
      • Rochester, Minnesota, États-Unis, 55905
        • Recrutement
        • Mayo Clinic Hospital - Rochester, MN
    • New York
      • New York, New York, États-Unis, 10065
        • Recrutement
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, États-Unis, 10016
        • Recrutement
        • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
    • North Carolina
      • Durham, North Carolina, États-Unis, 27710
        • Recrutement
        • Duke Cancer Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, États-Unis, 19107
        • Recrutement
        • Thomas Jefferson University, Sidney Kimmel Cancer Center
    • Tennessee
      • Nashville, Tennessee, États-Unis, 37203
        • Recrutement
        • Sarah Cannon Research Institute, LLC
    • Texas
      • Houston, Texas, États-Unis, 77030
        • Recrutement
        • The University of Texas - M.D. Anderson Cancer Center
    • Virginia
      • Fairfax, Virginia, États-Unis, 22031
        • Recrutement
        • NEXT Virginia
    • Washington
      • Seattle, Washington, États-Unis, 98109
        • Recrutement
        • Fred Hutchinson Cancer Center

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

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • ≥ 18 years or legal adult.

  • Pathologically confirmed diagnosis of locally advanced or metastatic NSCLC with EGFR or HER2 mutations in the kinase domain of exons 18, 19, 20, or 21.

  • Has at least 1 measurable target extracranial lesion according to RECIST v1.1.

  • Eastern Cooperative Oncology Group Performance Status ≤ 1.

  • Has a life expectancy of ≥ 3 months.

  • Has adequate hematologic, hepatic, and renal function.

    • The above are a summary; other Inclusion Criteria details may apply.

Exclusion Criteria:

  • History of any concurrent malignancy within the previous 2 years.

  • Known other oncogenic driver alterations (eg, moderate or high MET amplification) or histological transformation (eg, to small cell carcinoma, etc.).

  • Unresolved toxicities from prior therapies.

  • Any significant and uncontrolled medical condition, such as infection.

  • Active or history of interstitial lung disease from any cause

  • Clinically significant cardiovascular event within 6 months or significant history of major organ.

    • The above are a summary; other Exclusion Criteria details may apply.

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: Non randomisé
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Phase 1 Monotherapy Dose Escalation and Expansion
  • BH-30643 monotherapy for dose escalation
  • BH-30643 monotherapy for dose expansion/optimization at doses determined from dose escalation data
Médicament: BH-30643

BH-30643 will be provided as either 10 mg or 40 mg capsules or tablets. Subjects will take BH-30643 orally depending on their dose level assignment.

Médicament: BH-30643

BH-30643 will be provided as either 10 mg or 40 mg capsules. Subjects will take BH-30643 orally depending on their dose level assignment
Expérimental: Phase 1 Combination Dose Escalation and Expansion
  • BH-30643 combo therapy with Carboplatin/Pemetrexed for dose escalation
  • BH-30643 combo therapy with Carboplatin/Pemetrexed for dose expansion /optimization at doses determined from dose escalation data
Médicament: BH-30643 combo therapy with Carboplatin/Pemetrexed

BH-30643 will be provided as either 10 mg or 40 mg capsules or tablets in combo therapy with Carboplatin/Pemetrexed. Subjects will take BH-30643 orally depending on their dose level assignment. Carboplatin/Pemetrexed will be administered according to standard of care
Expérimental: Phase 2

BH-30643 administered at the RP2D dose determined in Phase 1
Médicament: BH-30643

BH-30643 will be provided as either 10 mg or 40 mg capsules or tablets. Subjects will take BH-30643 orally depending on their dose level assignment.

Médicament: BH-30643

BH-30643 will be provided as either 10 mg or 40 mg capsules. Subjects will take BH-30643 orally depending on their dose level assignment

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Dose-limiting toxicities (DLTs) (Phase 1, Dose Escalation)
Délai: Within the first 21 days of the first dose of BH-30643.

Assess dose-limiting toxicities (DLTs) as defined in the study protocol.
Within the first 21 days of the first dose of BH-30643.
Recommended Phase 2 dose (RP2D) (Phase 1, Dose Expansion/Optimization)
Délai: Within 21 days of last participant dosed during Dose Expansion/Optimization.

Determine the RP2D for Phase 2.
Within 21 days of last participant dosed during Dose Expansion/Optimization.
Objective Response Rate (ORR) (Phase 2)
Délai: Approximately 3 years after the first participant dosed.

Determine ORR as assessed by Blinded Independent Central Review (BICR).
Approximately 3 years after the first participant dosed.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Safety
Délai: From enrollment through study completion, approximately 48 months.

Assess incidence and severity of treatment-emergent adverse events (TEAEs), as defined by CTCAE, V5.0 (Phase 1 and Phase 2).
From enrollment through study completion, approximately 48 months.
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUClast) of BH-30643 for Single dose (Phase 1).
Délai: Predose and up to 24 hours postdose.

Determine area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUClast) of BH-30643.
Predose and up to 24 hours postdose.
Maximum observed plasma concentration (Cmax) of BH-30643 for Single dose (Phase 1).
Délai: Predose and up to 24 hours postdose.

Determine maximum observed plasma concentration (Cmax) of BH-30643.
Predose and up to 24 hours postdose.
Time to reach Cmax (Tmax) of BH-30643 for Single dose (Phase 1).
Délai: Predose and up to 24 hours postdose.

Determine time to reach Cmax (Tmax) of BH-30643.
Predose and up to 24 hours postdose.
Area under the plasma concentration-time curve at steady state (AUCss) of BH-30643 for multiple doses (Phase 1) at steady state.
Délai: Predose and up to 24 hours postdose.

Determine area under the plasma concentration-time curve at steady state (AUCss) of BH-30643.
Predose and up to 24 hours postdose.
Objective Response Rate (ORR)
Délai: From enrollment until the date of the first documented progression or death from any cause, whichever occurs first, assessed up to study ends or patient discontinue from the study, whichever occurs first (up to approximately 4 years).

The ORR is defined as a complete response (CR) or partial response (PR) per RECIST v1.1 recorded from first treatment until disease progression or start of new anti-cancer therapy. Both CR and PR must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met.
From enrollment until the date of the first documented progression or death from any cause, whichever occurs first, assessed up to study ends or patient discontinue from the study, whichever occurs first (up to approximately 4 years).
Disease Control Rate (DCR)
Délai: From enrollment until the date of the first documented progression or death from any cause, whichever occurs first, assessed up to study ends or patient discontinue from the study, whichever occurs first (up to approximately 4 years).

The DCR is defined as the percentage of subjects whose therapeutic intervention has led to a CR, PR, or stable disease (SD).
From enrollment until the date of the first documented progression or death from any cause, whichever occurs first, assessed up to study ends or patient discontinue from the study, whichever occurs first (up to approximately 4 years).
Time to Tumor Response (TTR)
Délai: From first dose to the first occurrence of response, assessed up to the date of first documented progression or death from any cause, whichever occurs first (up to approximately 4 years).

Time to tumor response (TTR) is defined for subjects with a confirmed objective response, as the time from the date of first treatment to the first documentation of objective response (CR or PR) which is subsequently confirmed.
From first dose to the first occurrence of response, assessed up to the date of first documented progression or death from any cause, whichever occurs first (up to approximately 4 years).
Duration of Response (DOR)
Délai: From first occurrence of response until the date of the first documented progression or death from any cause, whichever occurs first, assessed up to study end or patient discontinuation from the study, whichever occurs first (up to approximately 4 years)

The DOR is defined, for subjects with an objective response per RECIST v1.1, as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective tumor progression or death due to any cause, whichever occurs first.
From first occurrence of response until the date of the first documented progression or death from any cause, whichever occurs first, assessed up to study end or patient discontinuation from the study, whichever occurs first (up to approximately 4 years)
Progression-free Survival (PFS)
Délai: From enrollment until the date of the first documented progression or death from any cause, whichever occurs first, assessed up to study end or patient discontinuation from the study, whichever occurs first (up to approximately 4 years).

The endpoint PFS is defined as the time from the date of the first treatment to the date of the first documentation of objective progression of disease or death due to any cause, whichever occurs first.
From enrollment until the date of the first documented progression or death from any cause, whichever occurs first, assessed up to study end or patient discontinuation from the study, whichever occurs first (up to approximately 4 years).
Overall Survival
Délai: From enrollment until the date of death from any cause, assessed up to study end or patient discontinuation from the study, whichever occurs first (up to approximately 4 years).

Overall survival is defined as the time from the date of first treatment to the date of death due to any cause.
From enrollment until the date of death from any cause, assessed up to study end or patient discontinuation from the study, whichever occurs first (up to approximately 4 years).
ERTC-QLC-C30
Délai: From enrollment until the end of treatment, up till patient discontinue from treatment due to any reason (up to approximately 4 years).

Change from Baseline in Patient Reported Outcome European Organization for Research and Treatment Quality of Life Questionnaire (ERTC-QLC-C30) at Treatment Cycle 2 and beyond (Phase 2).
From enrollment until the end of treatment, up till patient discontinue from treatment due to any reason (up to approximately 4 years).
NSCLC-SAQ
Délai: From enrollment until the end of treatment, up till patient discontinues treatment for any reason (up to approximately 4 years).

Change from Baseline in Patient Reported Outcome Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) at Treatment Cycle 2 and beyond (Phase 2).
From enrollment until the end of treatment, up till patient discontinues treatment for any reason (up to approximately 4 years).

Collaborateurs et enquêteurs

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

Parrainer

BlossomHill Therapeutics

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 (Réel)

9 janvier 2025

Achèvement primaire (Estimé)

31 janvier 2029

Achèvement de l'étude (Estimé)

31 juillet 2029

Dates d'inscription aux études

Première soumission

19 novembre 2024

Première soumission répondant aux critères de contrôle qualité

22 novembre 2024

Première publication (Réel)

26 novembre 2024

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 novembre 2026

Dernière vérification

1 novembre 2025

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • BH-30643-01

Plan pour les données individuelles des participants (IPD)

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INDÉCIS

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

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

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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