NSCLC (Advanced Non-small Cell Lung Cancer)Phase 1/2SOLARANCT06706076
A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations
A Phase 1/2 study testing BH-30643 and BH-30643 combo therapy with Carboplatin/Pemetrexed in people with NSCLC (Advanced Non-small Cell Lung Cancer), run by BlossomHill Therapeutics at 43 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC (Advanced Non-small Cell Lung Cancer)
- What is being tested?
- BH-30643 and BH-30643 combo therapy with Carboplatin/Pemetrexed
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 675 participants
- Where
- 43 sitesin 9 countries
- Study dates
- 9 Jan 2025to 31 Jul 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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.
Trial locations and contacts
43 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
43 sites in 9 countries
United States25 sites, 25 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02214
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
Northwestern Medicine - Northwestern Memorial Hospital Galter Pavilion
Chicago, Illinois, 60611
- Recruiting
Henry Ford Health
Detroit, Michigan, 48202
- Recruiting
Duke Cancer Institute
Durham, North Carolina, 27710
- Recruiting
NEXT Virginia
Fairfax, Virginia, 22031
- Recruiting
The University of Texas - M.D. Anderson Cancer Center
Houston, Texas, 77030
- Recruiting
The Regents of the University of California - Irvine, CA Campus
Irvine, California, 92697
- Recruiting
Mayo Clinic - Florida
Jacksonville, Florida, 32224
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92093
- Recruiting
Cedars-Sinai Cancer at Cedars Sinai Medical Center
Los Angeles, California, 90048
- Recruiting
Sarah Cannon Research Institute, LLC
Nashville, Tennessee, 37203
- Recruiting
Yale University - Cancer Center
New Haven, Connecticut, 06520
- Recruiting
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Recruiting
Sarah Cancer Research Institution - Florida Cancer Specialist
Orlando, Florida, 32827
- Recruiting
Thomas Jefferson University, Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, 19107
- Recruiting
Mayo Clinic Hospital - Arizona
Phoenix, Arizona, 85054
- Recruiting
Mayo Clinic Hospital - Rochester, MN
Rochester, Minnesota, 55905
- Recruiting
University of California, Davis Comprehensive Cancer Center
Sacramento, California, 95817
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
- Recruiting
Stanford University Medical Center
Stanford, California, 94305
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
- Recruiting
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Japan3 sites, 3 recruiting
- Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba, 227-8577
- Recruiting
Kindai University Hospital
Osakasayama-shi, Osaka
- Recruiting
National Cancer Center Hospital
Tsukiji, Tokyo
South Korea3 sites, 3 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
- Recruiting
Asan Medical Center
Seoul, 05505
- Recruiting
Samsung Medical Center
Seoul, 06351
Taiwan3 sites, 3 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, 407219
- Recruiting
National Taiwan University Cancer Center
Taipei
- Recruiting
National Taiwan University Hospital
Taipei
Australia2 sites, 2 recruiting
- Recruiting
Austin Health
Heidelberg, Victoria, 3084
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Canada2 sites, 2 recruiting
- Recruiting
Cross Cancer Institute
Edmonton, Alberta, T6G1Z2
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2C4
Hong Kong2 sites, 2 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
- Recruiting
Prince of Wales Hospital
Shatin, New Territories
Singapore2 sites, 2 recruiting
- Recruiting
National University Hospital
Kent Ridge, 119074
- Recruiting
National Cancer Centre - Singapore
Singapore, 168583
Malaysia1 site, 1 recruiting
- Recruiting
Sarawak General Hospital
Kuching, Sarawak, 93586
About this study
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)
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.
Read the detailed description
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.
- Being tested
- BH-30643, BH-30643 combo therapy with Carboplatin/Pemetrexed
- Keywords
- NSCLC, Locally Advanced NSCLC, Metastatic NSCLC, Non-small Cell Lung Cancer, HER2 mutation, EGFR mutation, EGFR classical mutation, EGFR atypical mutation, EGFR exon20 insertion, EGFR uncommon mutation, EGFR resistant mutation, BH-30643, Tyrosine kinase inhibitor, TKI, EGFR, OMNI-EGFR, EGFR kinase domain mutations, EGFR common mutation, EGFR activating mutation, Ex19del
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BH-30643Drug
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.
BH-30643 combo therapy with Carboplatin/PemetrexedDrug
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
BH-30643Drug
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
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 Monotherapy Dose Escalation and Expansion | Experimental | * BH-30643 monotherapy for dose escalation
* BH-30643 monotherapy for dose expansion/optimization at doses determined from dose escalation data Receives: Drug: BH-30643 |
| Phase 1 Combination Dose Escalation and Expansion | Experimental | * 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 Receives: Drug: BH-30643 combo therapy with Carboplatin/Pemetrexed |
| Phase 2 | Experimental | BH-30643 administered at the RP2D dose determined in Phase 1 Receives: Drug: BH-30643 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicities (DLTs) (Phase 1, Dose Escalation)
Assess dose-limiting toxicities (DLTs) as defined in the study protocol.
Measured: Within the first 21 days of the first dose of BH-30643.
Recommended Phase 2 dose (RP2D) (Phase 1, Dose Expansion/Optimization)
Determine the RP2D for Phase 2.
Measured: Within 21 days of last participant dosed during Dose Expansion/Optimization.
Objective Response Rate (ORR) (Phase 2)
Determine ORR as assessed by Blinded Independent Central Review (BICR).
Measured: Approximately 3 years after the first participant dosed.
Secondary outcomes (13)
Safety
Assess incidence and severity of treatment-emergent adverse events (TEAEs), as defined by CTCAE, V5.0 (Phase 1 and Phase 2).
Measured: 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).
Determine area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUClast) of BH-30643.
Measured: Predose and up to 24 hours postdose.
Maximum observed plasma concentration (Cmax) of BH-30643 for Single dose (Phase 1).
Determine maximum observed plasma concentration (Cmax) of BH-30643.
Measured: Predose and up to 24 hours postdose.
Time to reach Cmax (Tmax) of BH-30643 for Single dose (Phase 1).
Determine time to reach Cmax (Tmax) of BH-30643.
Measured: 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.
Determine area under the plasma concentration-time curve at steady state (AUCss) of BH-30643.
Measured: Predose and up to 24 hours postdose.
Objective Response Rate (ORR)
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.
Measured: 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)
The DCR is defined as the percentage of subjects whose therapeutic intervention has led to a CR, PR, or stable disease (SD).
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
Overall survival is defined as the time from the date of first treatment to the date of death due to any cause.
Measured: 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
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).
Measured: From enrollment until the end of treatment, up till patient discontinue from treatment due to any reason (up to approximately 4 years).
NSCLC-SAQ
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).
Measured: From enrollment until the end of treatment, up till patient discontinues treatment for any reason (up to approximately 4 years).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start9 Jan 2025
- Primary completion31 Jan 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLC (Advanced Non-small Cell Lung Cancer)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 675 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BlossomHill Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706076
- Sponsor's protocol ID
- BH-30643-01
- Acronym
- SOLARA
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06706076
- Acronym / sponsor ID
- SOLARA / BH-30643-01
- Keywords
- NSCLC, Locally Advanced NSCLC, Metastatic NSCLC, Non-small Cell Lung Cancer, HER2 mutation, EGFR mutation, EGFR classical mutation, EGFR atypical mutation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 675 participants (estimated)
- Lead sponsor
- BlossomHill TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 31 Jan 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1 Monotherapy Dose Escalation and Expansion | Experimental | Drug: BH-30643* BH-30643 monotherapy for dose escalation * BH-30643 monotherapy for dose expansion/optimization at doses determined from dose escalation data |
| Phase 1 Combination Dose Escalation and Expansion | Experimental | Drug: BH-30643 combo therapy with Carboplatin/Pemetrexed* 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 |
| Phase 2 | Experimental | Drug: BH-30643BH-30643 administered at the RP2D dose determined in Phase 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥ 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BH-30643BH-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. | Drug | Phase 1 Monotherapy Dose Escalation and Expansion |
| BH-30643 combo therapy with Carboplatin/PemetrexedBH-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 | Drug | Phase 1 Combination Dose Escalation and Expansion |
| BH-30643BH-30643 will be provided as either 10 mg or 40 mg capsules. Subjects will take BH-30643 orally depending on their dose level assignment | Drug | Phase 1 Monotherapy Dose Escalation and Expansion, Phase 2 |
Primary outcome
Dose-limiting toxicities (DLTs) (Phase 1, Dose Escalation)
Time frame: Within the first 21 days of the first dose of BH-30643.
Assess dose-limiting toxicities (DLTs) as defined in the study protocol.
Recommended Phase 2 dose (RP2D) (Phase 1, Dose Expansion/Optimization)
Time frame: Within 21 days of last participant dosed during Dose Expansion/Optimization.
Determine the RP2D for Phase 2.
Objective Response Rate (ORR) (Phase 2)
Time frame: Approximately 3 years after the first participant dosed.
Determine ORR as assessed by Blinded Independent Central Review (BICR).
13 secondary outcomes
Safety
Time frame: 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).
Time frame: Predose and up to 24 hours postdose.
Maximum observed plasma concentration (Cmax) of BH-30643 for Single dose (Phase 1).
Time frame: Predose and up to 24 hours postdose.
Time to reach Cmax (Tmax) of BH-30643 for Single dose (Phase 1).
Time frame: 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.
Time frame: Predose and up to 24 hours postdose.
Objective Response Rate (ORR)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: From enrollment until the end of treatment, up till patient discontinue from treatment due to any reason (up to approximately 4 years).
NSCLC-SAQ
Time frame: From enrollment until the end of treatment, up till patient discontinues treatment for any reason (up to approximately 4 years).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
43 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BH-30643 and BH-30643 combo therapy with Carboplatin/Pemetrexed in people with NSCLC (Advanced Non-small Cell Lung Cancer), run by BlossomHill Therapeutics at 43 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Japan, South Korea, Taiwan, Australia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sponsor Contact ((858) 732-3880, clinicaltrials@bhtherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicities (DLTs) (Phase 1, Dose Escalation) (time frame: Within the first 21 days of the first dose of BH-30643.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.