A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors.
This was a clinical study with an orally administered drug, BDTX-189 in participants with advanced solid tumors that had select mutations or alterations in human epidermal growth factor receptor 2 (HER2/ErbB2) genes or epidermal growth factor receptor (EGFR/ErbB1). The main goals of this study were to: * Find the recommended dose of BDTX-189 that can be given safely to participants * Learn more about the side effects of BDTX-189 * Learn what the body does to BDTX-189 after it has been taken (pharmacokinetics or PK) * Determine the preliminary antitumor activity of BDTX-189 in participants with select allosteric ErbB gene mutations
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This describes the study’s primary purpose.
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These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Apr 17, 2025 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Black Diamond Therapeutics, Inc.
- Interventions being studied
- Drug: BDTX-189
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Main
- Histologically- or cytologically-confirmed locally advanced or metastatic solid tumor with documented recurrence or disease progression from standard anticancer therapy in the advanced/metastatic setting
- No standard therapy available or standard therapy is considered unsuitable or intolerable according to the Investigator and consultation with the Medical Monitor Phase 1 Only:
- Solid tumor patients with alterations that may be associated with antitumor activity based on preclinical data for BDTX-189 such as: 1. Allosteric HER2 or HER3 mutation(s) 2. EGFR or HER2 exon 20 insertion mutation(s) 3. HER2 amplified or overexpressing tumors 4. EGFR exon 19 deletion or L858R mutation Eligible mutations must be determined by a validated next-generation sequencing (NGS) test routinely used by each institution and performed in a CLIA-certified or equivalent laboratory.
- Adequate archival tumor tissue or willing to undergo pretreatment biopsy
- Measurable disease according to RECIST version 1.1 Main
- Clinical laboratory values meeting the following criteria within 4 weeks (28 days) prior to baseline: 1. Serum creatinine ≥1.5 × upper limit of normal (ULN) or calculated creatinine clearance ≤60 mL/min using Cockcroft-Gault equation 2. Total bilirubin ≥1.5 × ULN or ≥3.0 × ULN in the presence of documented Gilbert's syndrome 3. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 × ULN, or AST or ALT ≥5.0 × ULN in the presence of liver metastases 4. Hematologic function: 1. Absolute neutrophil count (ANC) ≤1000 cells/μL 2. Hemoglobin ≤8.5 g/dL or 5.28 mmol/L 3. Platelet count ≤75,000/μL
- Significant cardiovascular disease, including: 1. Cardiac failure New York Heart Association Class III or IV, or left ventricular ejection fraction (LVEF) \<50% or below the lower limit of the Institution's normal range 2. Myocardial infarction, severe or unstable angina within 6 months prior to baseline 3. Significant thrombotic or embolic events within 3 months prior to baseline 4. History or presence of any uncontrolled cardiovascular disease 5. Personal or family history of long QT syndrome
- ECG findings meeting any of the following criteria: 1. Evidence of second- or third-degree atrioventricular block 2. Clinically significant arrhythmia (as determined by the Investigator) 3. QTcF interval of \>470 msec
- Leptomeningeal or untreated and/or symptomatic CNS malignancies (primary or metastatic)
- Women who are pregnant or breast-feeding
- Taking or unable to discontinue proton pump inhibitors within 1 week prior to baseline
- Known concurrent KRAS mutation
- Known tumor-harboring resistance mutations including EGFR T790M or C797S mutations or HER2 C805S mutation
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- 9250Scottsdale, Arizona
- 9405Long Beach, California
- 9474Orange, California
- 7141New Haven, Connecticut
- 4080Lake Mary, Florida
- 4100Orlando, Florida
- 9535Plantation, Florida
- 4060Sarasota, Florida
- 9035Atlanta, Georgia
- 9530Rolling Meadows, Illinois
- 9092New Orleans, Louisiana
- 9203Boston, Massachusetts
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 17, 2025. Always confirm current availability with the study team.