Tests BH-30643 in lung cancer with EGFR or HER2 mutations
Tests the drug BH-30643, alone or with chemotherapy, in adults with advanced lung cancer.
Plain-language title generated from the registry record
Registry title: A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations
Key facts
- Where
- Taichung and Taipei, TaiwanSee the 3 sites
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or spread non-small cell lung cancer that has an EGFR or HER2 gene change. It tests a new drug, BH-30643.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Locally advanced or metastatic non-small cell lung cancer (NSCLC), with at least 1 measurable tumour outside the brain and good daily functioning (ECOG performance status 1 or lower).
- Earlier treatment
- People with unresolved side effects from earlier treatments cannot join.
- Biomarker or test result
- An EGFR or HER2 mutation in the kinase domain, in exon 18, 19, 20 or 21.
Main reasons for not taking part
- Another cancer within the previous 2 years
- Other known cancer-driving gene changes, or the tumour changing to another cell type
- Active or past interstitial lung disease
- Serious uncontrolled medical conditions, such as an infection
- Serious heart or blood vessel event within 6 months
Read by machine on 12 November 2026.
Where in Taiwan
- Taichung Veterans General HospitalTaichung, TaiwanTaking people
- National Taiwan University Cancer CenterTaipei, TaiwanTaking people
- National Taiwan University HospitalTaipei, TaiwanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- BlossomHill Therapeutics
- Trial code
- NCT06706076
- Record updated
- 4 November 2026
- Original description
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.Read full original descriptionShow less
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)
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.
Inclusion: ≥ 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: History of any concurrent malignancy within the previous 2 years; 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; Known other oncogenic driver alterations (eg, moderate or high MET amplification) or histological transformation (eg, to small cell carcinoma, etc.).