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Terminated Phase 1 Interventional Results available

A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors.

ClinicalTrials.gov ID: NCT04209465

Public ClinicalTrials.gov record NCT04209465. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 6:55 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

MasterKey-01: A Phase 1/2, Open-label, Two-part, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics & Antitumor Activity of BDTX-189, an Inhibitor of Allosteric ErbB Mutations, in Patients w/ Advanced Solid Malignancies

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT04209465
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 1
Enrollment
91 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 19, 2019 (Actual)
Primary completion
Sep 2, 2022 (Actual)
Completion
Sep 16, 2022 (Actual)
Last update posted
Apr 17, 2025

2019 – 2022

United States locations

U.S. sites
24
U.S. states
15
U.S. cities
23
Facility City State ZIP Site status
9250 Scottsdale Arizona 85258 —
9405 Long Beach California 90813 —
9474 Orange California 92868 —
7141 New Haven Connecticut 06520 —
4080 Lake Mary Florida 32746 —
4100 Orlando Florida 32827 —
9535 Plantation Florida 33322 —
4060 Sarasota Florida 34232 —
9035 Atlanta Georgia 30322 —
9530 Rolling Meadows Illinois 60008 —
9092 New Orleans Louisiana 70112 —
9203 Boston Massachusetts 02215 —
9209 Buffalo New York 14263 —
9215 New York New York 10016 —
9236 New York New York 10065 —
9264 Portland Oregon 97213 —
7122 Pittsburgh Pennsylvania 15232 —
4107 Chattanooga Tennessee 37404 —
3000 Nashville Tennessee 37203 —
9003 Dallas Texas 75390 —
9117 Houston Texas 77030 —
9538 Webster Texas 77598 —
9112 Fairfax Virginia 22031 —
9173 Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04209465, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 17, 2025 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04209465 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →