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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06706076
Registration number
NCT06706076
Ethics application status
Date submitted
19/11/2024
Date registered
26/11/2024
Date last updated
5/09/2025
Titles & IDs
Public title
A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations
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Scientific title
A Phase 1/2 Open-Label, Multicenter, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of BH-30643 in Adult Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations (SOLARA)
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Secondary ID [1]
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BH-30643-01
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Universal Trial Number (UTN)
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Trial acronym
SOLARA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
NSCLC (Advanced Non-small Cell Lung Cancer)
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Condition category
Condition code
Cancer
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Lung - Non small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BH-30643
Treatment: Drugs - BH-30643
Experimental: Phase 1 Dose Escalation and Expansion - * BH-30643 monotherapy for dose escalation
* BH-30643 monotherapy for dose expansion/optimization at doses determined from dose escalation data
* BH-30643 twice daily oral dosing
Experimental: Phase 2 - BH-30643 administered at the RP2D dose determined in Phase 1
Treatment: Drugs: 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.
Treatment: Drugs: 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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Dose-limiting toxicities (DLTs) (Phase 1, Dose Escalation)
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Assessment method [1]
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Assess dose-limiting toxicities (DLTs) as defined in the study protocol.
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Timepoint [1]
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Within the first 21 days of the first dose of BH-30643.
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Primary outcome [2]
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Recommended Phase 2 dose (RP2D) (Phase 1, Dose Expansion/Optimization)
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Assessment method [2]
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Determine the RP2D for Phase 2.
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Timepoint [2]
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Within 21 days of last participant dosed during Dose Expansion/Optimization.
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Primary outcome [3]
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Objective Response Rate (ORR) (Phase 2)
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Assessment method [3]
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Determine ORR as assessed by Blinded Independent Central Review (BICR).
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Timepoint [3]
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Approximately 3 years after the first participant dosed.
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Secondary outcome [1]
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Safety
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Assessment method [1]
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Assess incidence and severity of treatment-emergent adverse events (TEAEs), as defined by CTCAE, V5.0 (Phase 1 and Phase 2).
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Timepoint [1]
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From enrollment through study completion, approximately 48 months.
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Secondary outcome [2]
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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).
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Assessment method [2]
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Determine area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUClast) of BH-30643.
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Timepoint [2]
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Predose and up to 24 hours postdose.
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Secondary outcome [3]
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Maximum observed plasma concentration (Cmax) of BH-30643 for Single dose (Phase 1).
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Assessment method [3]
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Determine maximum observed plasma concentration (Cmax) of BH-30643.
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Timepoint [3]
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Predose and up to 24 hours postdose.
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Secondary outcome [4]
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Time to reach Cmax (Tmax) of BH-30643 for Single dose (Phase 1).
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Assessment method [4]
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Determine time to reach Cmax (Tmax) of BH-30643.
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Timepoint [4]
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Predose and up to 24 hours postdose.
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Secondary outcome [5]
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Area under the plasma concentration-time curve at steady state (AUCss) of BH-30643 for multiple doses (Phase 1) at steady state.
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Assessment method [5]
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Determine area under the plasma concentration-time curve at steady state (AUCss) of BH-30643.
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Timepoint [5]
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Predose and up to 24 hours postdose.
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Secondary outcome [6]
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Objective Response Rate (ORR)
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Assessment method [6]
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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.
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Timepoint [6]
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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).
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Secondary outcome [7]
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Disease Control Rate (DCR)
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Assessment method [7]
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The DCR is defined as the percentage of subjects whose therapeutic intervention has led to a CR, PR, or stable disease (SD).
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Timepoint [7]
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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).
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Secondary outcome [8]
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Clinical benefit Rate (CBR)
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Assessment method [8]
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The CBR is defined as the percentage of subjects who achieve a CR, PR, or at least 12 weeks of SD as a result of therapy.
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Timepoint [8]
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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).
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Secondary outcome [9]
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Time to Tumor Response (TTR)
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Assessment method [9]
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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.
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Timepoint [9]
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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).
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Secondary outcome [10]
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Duration of Response (DOR)
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Assessment method [10]
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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.
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Timepoint [10]
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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 ends or patient discontinue from the study, whichever occurs first (up to approximately 4 years).
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Secondary outcome [11]
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Progression-free Survival (PFS)
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Assessment method [11]
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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.
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Timepoint [11]
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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).
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Secondary outcome [12]
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Overall Survival
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Assessment method [12]
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Overall survival is defined as the time from the date of first treatment to the date of death due to any cause.
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Timepoint [12]
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From enrollment until the date of death from any cause, assessed up to study ends or patient discontinue from the study, whichever occurs first (up to approximately 4 years).
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Secondary outcome [13]
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ERTC-QLC-C30
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Assessment method [13]
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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 (in Phase 1 Part 2 and Phase 2).
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Timepoint [13]
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From enrollment until the end of treatment, up till patient discontinue from treatment due to any reason (up to approximately 4 years).
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Secondary outcome [14]
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NSCLC-SAQ
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Assessment method [14]
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Change from Baseline in Patient Reported Outcome Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) at Treatment Cycle 2 and beyond (in Phase 1 Part 2 and Phase 2).
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Timepoint [14]
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From enrollment until the end of treatment, up till patient discontinue from treatment due to any reason (up to approximately 4 years).
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Eligibility
Key inclusion criteria
* = 18 years or legal adult.
* Pathologically confirmed diagnosis of locally advanced or metastatic NSCLC with EGFR (classical, atypical, exon20 insertion) or HER2 mutations in the kinase domain of exons 18, 19, 20, or 21. EGFR mutations include activating and acquired EGFR resistance mutations that might form compound mutations.
* Had received standard therapies.
* 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
* History of interstitial lung disease from any cause
* Clinically significant cardiovascular event within 6 months or significant history of major organ.
* Actively receiving investigational therapy(ies) in another clinical study. *The above are a summary; other Exclusion Criteria details may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
9/01/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/07/2029
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Actual
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Sample size
Target
266
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Austin Health - Heidelberg
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Recruitment hospital [2]
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Peter MacCallum Cancer Centre - Melbourne
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Recruitment postcode(s) [1]
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3084 - Heidelberg
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Recruitment postcode(s) [2]
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3000 - Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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California
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Country [3]
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United States of America
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State/province [3]
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Florida
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Country [4]
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United States of America
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State/province [4]
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Illinois
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Country [5]
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United States of America
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State/province [5]
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Massachusetts
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Country [6]
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United States of America
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State/province [6]
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Michigan
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Country [7]
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United States of America
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State/province [7]
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Minnesota
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Country [8]
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United States of America
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State/province [8]
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Pennsylvania
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Country [9]
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United States of America
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State/province [9]
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Tennessee
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Country [10]
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United States of America
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State/province [10]
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Texas
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Country [11]
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United States of America
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State/province [11]
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Virginia
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Country [12]
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Hong Kong
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State/province [12]
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New Territories
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Country [13]
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Japan
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State/province [13]
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Chiba
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Country [14]
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Japan
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State/province [14]
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Osaka
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Country [15]
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Japan
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State/province [15]
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Tokyo
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Country [16]
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Singapore
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State/province [16]
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Kent Ridge
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
BlossomHill Therapeutics
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
BH-30643-01 is a Phase 1/2, first-in-human, open label, dose escalation and expansion study in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) and/or human epidermal growth factor receptor (HER2) mutations. The study drug, BH-30643 capsules, will be self-administered by mouth twice daily in 21-day cycles. Phase 1 will determine the recommended Phase 2 dose (RP2D) and, if applicable, the maximum tolerated dose (MTD) of BH-30643. 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.
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Trial website
https://clinicaltrials.gov/study/NCT06706076
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Sponsor Contact
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Address
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Country
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Phone
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(858) 732-3880
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06706076
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