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Een onderzoek naar BH-30643 bij proefpersonen met lokaal gevorderd of gemetastaseerd NSCLC met EGFR- en/of HER2-mutaties (SOLARA)

2 november 2026 bijgewerkt door: BlossomHill Therapeutics

Een fase 1/2 open-label, multicenter, first-in-human onderzoek naar de veiligheid, verdraagbaarheid, farmacokinetiek en antitumoractiviteit van BH-30643 bij proefpersonen met lokaal gevorderd of gemetastaseerd NSCLC met EGFR- en/of HER2-mutaties (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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

675

Fase

  • Fase 2
  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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
Geneesmiddel: 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.

Geneesmiddel: 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
Experimenteel: 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
Geneesmiddel: 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
Experimenteel: Phase 2

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

Geneesmiddel: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Dose-limiting toxicities (DLTs) (Phase 1, Dose Escalation)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Safety
Tijdsspanne: 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).
Tijdsspanne: 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).
Tijdsspanne: 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).
Tijdsspanne: 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.
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

BlossomHill Therapeutics

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

9 januari 2025

Primaire voltooiing (Geschat)

31 januari 2029

Studie voltooiing (Geschat)

31 juli 2029

Studieregistratiedata

Eerst ingediend

19 november 2024

Eerst ingediend dat voldeed aan de QC-criteria

22 november 2024

Eerst geplaatst (Werkelijk)

26 november 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 november 2025

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • BH-30643-01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Ja

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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