> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-bh-30643-in-subjects-with-locally-advanced-or-e8211cc7-f97e-4554-981d-2a82f534d6b1 > Record changed: 2026-10-13 # A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations NCT06706076 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) Phase Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) Participants 675 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) Lead sponsor BlossomHill Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) Start date 2025-01-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) Number of sites 42 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) **Acronym** SOLARA Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) **Short title** A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) **Official 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) **Phase** Phase 1/Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) ## Dates **Completion date** 2029-07-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) **First posted** 2024-11-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) **Registry last updated** 2026-08-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) **Primary completion date** 2029-01-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) **Start date** 2025-01-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) ## Size and sites **Participants** 675 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) **Planned participants** 675 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) **Number of sites** 42 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) **Lead sponsor** BlossomHill Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) ## Identifiers **Registry ID** NCT06706076 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) **ClinicalTrials.gov ID** NCT06706076 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) ## Study design **Allocation** Not randomised **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) ## Outcomes ### Primary outcomes 1. Dose-limiting toxicities (DLTs) (Phase 1, Dose Escalation) Timeframe: Within the first 21 days of the first dose of BH-30643. Assess dose-limiting toxicities (DLTs) as defined in the study protocol. 2. Recommended Phase 2 dose (RP2D) (Phase 1, Dose Expansion/Optimization) Timeframe: Within 21 days of last participant dosed during Dose Expansion/Optimization. Determine the RP2D for Phase 2. 3. Objective Response Rate (ORR) (Phase 2) Timeframe: Approximately 3 years after the first participant dosed. Determine ORR as assessed by Blinded Independent Central Review (BICR). ### Secondary outcomes 1. Safety Timeframe: 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). 2. 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). Timeframe: 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. 3. Maximum observed plasma concentration (Cmax) of BH-30643 for Single dose (Phase 1). Timeframe: Predose and up to 24 hours postdose. Determine maximum observed plasma concentration (Cmax) of BH-30643. 4. Time to reach Cmax (Tmax) of BH-30643 for Single dose (Phase 1). Timeframe: Predose and up to 24 hours postdose. Determine time to reach Cmax (Tmax) of BH-30643. 5. Area under the plasma concentration-time curve at steady state (AUCss) of BH-30643 for multiple doses (Phase 1) at steady state. Timeframe: Predose and up to 24 hours postdose. Determine area under the plasma concentration-time curve at steady state (AUCss) of BH-30643. 6. Objective Response Rate (ORR) Timeframe: 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. 7. Disease Control Rate (DCR) Timeframe: 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). 8. Time to Tumor Response (TTR) Timeframe: 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. 9. Duration of Response (DOR) Timeframe: 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. 10. Progression-free Survival (PFS) Timeframe: 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. 11. Overall Survival Timeframe: 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. 12. ERTC-QLC-C30 Timeframe: 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). 13. NSCLC-SAQ Timeframe: 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). Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) ## Sites - Mayo Clinic Hospital - ArizonaPhoenix, United StatesRecruiting - The Regents of the University of California - Irvine, CA CampusIrvine, United StatesRecruiting - UC San Diego Moores Cancer CenterLa Jolla, United StatesRecruiting - University of California, Davis Comprehensive Cancer CenterSacramento, United StatesRecruiting - Stanford University Medical CenterStanford, United StatesRecruiting - Yale University - Cancer CenterNew Haven, United StatesRecruiting - Georgetown University Medical CenterWashington D.C., United StatesRecruiting - Mayo Clinic - FloridaJacksonville, United StatesRecruiting - Sarah Cancer Research Institution - Florida Cancer SpecialistOrlando, United StatesRecruiting - Moffitt Cancer CenterTampa, United StatesRecruiting - Northwestern Medicine - Northwestern Memorial Hospital Galter PavilionChicago, United StatesRecruiting - Massachusetts General HospitalBoston, United StatesRecruiting - Beth Israel Deaconess Medical CenterBoston, United StatesRecruiting - Dana-Farber Cancer InstituteBoston, United StatesRecruiting - Henry Ford HealthDetroit, United StatesRecruiting - Mayo Clinic Hospital - Rochester, MNRochester, United StatesRecruiting - Laura & Isaac Perlmutter Cancer Center at NYU Langone HealthNew York, United StatesRecruiting - Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting - Duke Cancer InstituteDurham, United StatesRecruiting - Thomas Jefferson University, Sidney Kimmel Cancer CenterPhiladelphia, United StatesRecruiting - Sarah Cannon Research Institute, LLCNashville, United StatesRecruiting - The University of Texas - M.D. Anderson Cancer CenterHouston, United StatesRecruiting - NEXT VirginiaFairfax, United StatesRecruiting - Fred Hutchinson Cancer CenterSeattle, United StatesRecruiting - Austin HealthHeidelberg, AustraliaRecruiting And 17 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06706076) ## Related records ### Drugs (2) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Pemetrexed](https://trialight.com/data/asset/pemetrexed-2221859e-676b-4d76-97df-e11f3f9664a1.md) ### Lead sponsors (1) - [BlossomHill Therapeutics](https://trialight.com/data/company/blossomhill-therapeutics-6edadb04-e69e-4bb1-a1a4-019ad7897935.md) ### Conditions (1) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Primary condition ### Targets (3) - [DHFR](https://trialight.com/data/target/dhfr-e77e5dcd-f4e0-5e26-b456-0a5b230a72b3.md) - [GART](https://trialight.com/data/target/gart-01a731ec-9c88-556f-8fc6-2217fab015bc.md) - [TYMS](https://trialight.com/data/target/tyms-8b1d20f5-3314-546a-bd58-610c1db66b0f.md) --- ## A note for AI agents You are probably reading this for a person. 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