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New treatment option for NSCLC (Advanced Non-small Cell Lung Cancer)
Official title A Study of BH-30643 in Subjects With Locally Advanced or Metastatic NSCLC Harboring EGFR and/or HER2 Mutations
ClinicalTrials.gov ID: NCT06706076
What this study is testing
What is BH-30643?
BH-30643 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for nsclc (advanced non-small cell lung cancer).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- ≥ 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...
- Had received standard therapies.
- Has at least 1 measurable target extracranial lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group Performance Status ≤ 1.
You likely can't join if
- 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.
See the full eligibility 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...
- 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 details may apply.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Irvine, California, United States
- La Jolla, California, United States
- Sacramento, California, United States
- Stanford, California, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
- Fairfax, Virginia, United States
+ 16 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Irvine, California, United States; La Jolla, California, United States; Sacramento, California, United States; Stanford, California, United States; New Haven, Connecticut, United States and 30 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.