Solid TumorPhase 1MasterKey-01NCT04209465

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

A Phase 1 study testing BDTX-189 in people with Solid Tumor, run by Black Diamond Therapeutics, Inc. at 38 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumor
What is being tested?: BDTX-189
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 91 participants
Where: 38 sitesin 4 countries
Study dates: 19 Dec 2019to 16 Sep 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Main Inclusion Criteria:

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:

Allosteric HER2 or HER3 mutation(s)
EGFR or HER2 exon 20 insertion mutation(s)
HER2 amplified or overexpressing tumors
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 Exclusion Criteria:

Clinical laboratory values meeting the following criteria within 4 weeks (28 days) prior to baseline:

Serum creatinine ≥1.5 × upper limit of normal (ULN) or calculated creatinine clearance ≤60 mL/min using Cockcroft-Gault equation
Total bilirubin ≥1.5 × ULN or ≥3.0 × ULN in the presence of documented Gilbert's syndrome
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 × ULN, or AST or ALT ≥5.0 × ULN in the presence of liver metastases
Hematologic function:
Absolute neutrophil count (ANC) ≤1000 cells/μL
Hemoglobin ≤8.5 g/dL or 5.28 mmol/L
Platelet count ≤75,000/μL

Significant cardiovascular disease, including:

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
Myocardial infarction, severe or unstable angina within 6 months prior to baseline
Significant thrombotic or embolic events within 3 months prior to baseline
History or presence of any uncontrolled cardiovascular disease
Personal or family history of long QT syndrome

ECG findings meeting any of the following criteria:

Evidence of second- or third-degree atrioventricular block
Clinically significant arrhythmia (as determined by the Investigator)
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

Trial locations and contacts

38 sites in 4 countries.

Country

City, postcode or hospital

38 sites in 4 countries

United States24 sites

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

Other trials in United States

Spain8 sites

9496
Barcelona, 08028
9363
Barcelona, 08035
9508
Barcelona, 08036
9429
Madrid, 28007
9495
Madrid, 28040
9383
Madrid, 28041
9382
Madrid, 28050
9510
Valencia, 46010

Other trials in Spain

France5 sites

9501
Bordeau, 33000
9525
Lille, 59000
9373
Lyon, 69008
9512
Poitiers, 86021
9476
Rennes, 44229

Other trials in France

Denmark1 site

9500
Copenhagen

Other trials in Denmark

About this study

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

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

Read the detailed description

BDTX-189 is an irreversible, small molecular inhibitor that is highly selective versus wild-type EGFR and potent for cancer driver mutations of the ErbB family, including extracellular, transmembrane, and kinase domain allosteric mutations of HER2, as well as EGFR and HER2 exon 20 insertion mutations. These allosteric ErbB mutations are found in 1 - 2 % of most solid tumors and enriched in some cancers with a prevalence of about 2 - 7% such as in non-small cell lung cancer, breast cancer, colorectal cancer, bladder cancer, and endometrial cancer. Currently approved HER2 and EGFR directed therapies are not active against the spectrum of allosteric mutations at relevant and tolerated exposure levels.

This Phase 1/2 multi-center, open-label trial was a first-in-human study that evaluated BDTX-189 orally administered daily as a single agent in patients with solid tumors harboring select mutations or alterations. The Phase 1 portion was a dose escalation primarily designed to assess the safety and tolerability of BDTX-189 and to determine a recommended Phase 2 dose (RP2D). Phase 1 focused on patients with a solid tumor and with alterations such as:

Allosteric HER2 or HER3 mutation(s)
EGFR or HER2 exon 20 insertion mutation(s)
HER2 amplified or overexpressing tumors
EGFR exon 19 deletion or L858R mutation

Eligible mutations must have been determined by a validated next-generation sequencing (NGS) test routinely used by each institution and performed in a CLIA-certified or equivalent laboratory.

The Phase 2 portion was not initiated.

Conditions: Solid Tumor
Being tested: BDTX-189
Keywords: solid tumor, HER2 mutation, exon 20 insertion mutation, HER2 positive, Genes, HER2, Genes, erbb2, HER2 amplification, HER2 overexpression, genes, exon 20 insertion, lung cancer, non-small cell lung cancer, breast cancer, colon cancer, colorectal cancer, bladder cancer, endometrial cancer, gastric cancer, biliary tract cancer
Medical subject headings: Lung Neoplasms, Carcinoma, Non-Small-Cell Lung, Breast Neoplasms, Colonic Neoplasms, Colorectal Neoplasms, Urinary Bladder Neoplasms, Endometrial Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BDTX-189Drug
Participants received a daily, oral dose of BDTX-189 as part of a 3 week cycle.

Study groups in NCT04209465
Study group	Role	What they receive
Phase 1 - Dose escalation	Experimental	In Part A, cohorts of patients with select HER2, HER3, or EGFR alterations received increasing doses of BDTX-189. Receives: Drug: BDTX-189

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Dose Limiting Toxicities as a Determinant of the Recommended Phase 2 Dose (RP2D)
Certain toxicities will be considered dose-limiting unless clearly attributable to an extraneous cause, such as underlying disease.
Measured: After the first dose of treatment for up to 21 days.

Secondary outcomes (4)

Phase 1: Incidence of Treatment-emergent Adverse Events as a Measure of Safety and Tolerability of BDTX-189
Adverse events will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.
Measured: From Cycle 1 Day 1 (each cycle is 21 days) until 30 days post last dose
Phase 1: Plasma Concentration of BDTX-189 as a Measure of Pharmacokinetics
Blood samples will be taken to measure the plasma concentrations of BDTX-189 in both a fed and fasted state.
Measured: Multiple time points during Cycles 1-4 (each cycle is 21 days)
Phase 1: Objective Response Rate as a Preliminary Measure of Antitumor Activity
Objective response is defined as the proportion of participants who achieved a complete response (CR; disappearance of all target and non-target lesions) or partial response (PR; at least a 30% decrease from baseline in the sum of diameters of target lesions) per RECIST version 1.1.
Measured: Assessed until disease progression or death for up to 12 months
Phase 1: Progression-free Survival as a Measure of Antitumor Activity
Progression-free survival is the time from first study dose until disease progression (PD; target lesion increase of 20% and at least 5mm from smallest on-study lesion sum, the appearance of new lesions, or unequivocal progression of non-target lesions) per RECIST v1.1.
Measured: Assessed until disease progression or death for up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Dec 201916 Sep 2022

First posted24 Dec 2019
Study start19 Dec 2019
Primary completion2 Sep 2022
Study completion16 Sep 2022

Why it stopped: The development of BDTX-189 was discontinued by the sponsor.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Solid TumorStudies 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
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04209465
Sponsor's protocol ID: BDTX-189-01
Acronym: MasterKey-01
Status last verified: Apr 2024
First submitted: 19 Dec 2019
Last updated: 17 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Erika Paige Hamilton, Manish R. Patel, Jordi Rodon, David S. Hong, Alison M. Schram, Pasi A. Janne, Patricia LoRusso, Jasgit C. Sachdev, Sai Hong Ou, Elizabeth A Buck, Matthew O'Connor, Nigel Waters, Karsten Witt, Carl Cook. Masterkey-01: Phase I/II, open-label multicenter study to assess safety, tolerability, pharmacokinetics, and antitumor activity of BDTX-189, an inhibitor of allosteric ErbB mutations, in patients with advanced solid malignancies. J Clin Oncol 38: 2020 (suppl; abstr TPS3665)

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04209465
Acronym / sponsor ID: MasterKey-01 / BDTX-189-01
Conditions: Solid Tumor
Keywords: solid tumor, HER2 mutation, exon 20 insertion mutation, HER2 positive, Genes, HER2, Genes, erbb2, HER2 amplification, HER2 overexpression
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: The development of BDTX-189 was discontinued by the sponsor.
Enrolment: 91 participants (actual)
Lead sponsor: Black Diamond Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 19 Dec 2019 (actual)
Primary completion: 2 Sep 2022 (actual)
Study completion: 16 Sep 2022 (actual)
First posted: 24 Dec 2019 (actual)
Results: Posted 17 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Allosteric HER2 or HER3 mutation(s)
EGFR or HER2 exon 20 insertion mutation(s)
HER2 amplified or overexpressing tumors
EGFR exon 19 deletion or L858R mutation

Eligible mutations must have been determined by a validated next-generation sequencing (NGS) test routinely used by each institution and performed in a CLIA-certified or equivalent laboratory.

The Phase 2 portion was not initiated.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Phase 1 - Dose escalation	Experimental	Drug: BDTX-189In Part A, cohorts of patients with select HER2, HER3, or EGFR alterations received increasing doses of BDTX-189.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
BDTX-189Participants received a daily, oral dose of BDTX-189 as part of a 3 week cycle.	Drug	Phase 1 - Dose escalation

Primary outcome

Number of Dose Limiting Toxicities as a Determinant of the Recommended Phase 2 Dose (RP2D)
Time frame: After the first dose of treatment for up to 21 days.
Certain toxicities will be considered dose-limiting unless clearly attributable to an extraneous cause, such as underlying disease.

4 secondary outcomes

Phase 1: Incidence of Treatment-emergent Adverse Events as a Measure of Safety and Tolerability of BDTX-189
Time frame: From Cycle 1 Day 1 (each cycle is 21 days) until 30 days post last dose
Phase 1: Plasma Concentration of BDTX-189 as a Measure of Pharmacokinetics
Time frame: Multiple time points during Cycles 1-4 (each cycle is 21 days)
Phase 1: Objective Response Rate as a Preliminary Measure of Antitumor Activity
Time frame: Assessed until disease progression or death for up to 12 months
Phase 1: Progression-free Survival as a Measure of Antitumor Activity
Time frame: Assessed until disease progression or death for up to 12 months

Results and safety

Results posted to the registry on 17 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dose Escalation 25 mg QD	1	0
Dose Escalation 50 mg QD	1	0
Dose Escalation 100 mg QD	1	0
Dose Escalation 200 mg QD	2	0
Dose Escalation 400 mg QD	10	0
Dose Escalation 800 mg QD	18	2
Dose Escalation 800 mg QD Not Fasted	13	3
Dose Escalation 1000 mg QD	7	1
Dose Escalation 1200 mg QD	6	0
Dose Escalation 400 mg BID	4	0
Dose Escalation 600 mg BID	6	1
Dose Escalation 800 mg BID	5	0
Phase 1 Safety Expansion	17	1

Primary outcome: Number of Dose Limiting Toxicities as a Determinant of the Recommended Phase 2 Dose (RP2D)

Time frame: After the first dose of treatment for up to 21 days.. Number. Unit: participants

Measure	25 mg QD n = 1	50 mg QD n = 1	100 mg QD n = 1	200 mg QD n = 2	400 mg QD n = 10	800 mg QD Fasted n = 18	800 mg QD Not Fasted n = 13	1000 mg QD n = 7	1200 mg QD n = 6	400 mg BID n = 4	600 mg BID n = 6	800 mg BID n = 5	Safety Expansion Set 800 mg QD n = 17
Value	0	0	0	0	0	0	1	2	2	0	3	3	1

Population analysed: DLT-Evaluable

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Patients remained on-study (on-treatment) until progression, adverse event, or withdrawal of consent. Mean duration of treatment across all dose levels was 11.7 months (median was 6.6 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dose Escalation 25 mg QD	0 of 1 (0%)	1 of 1 (100%)	1 of 1
Dose Escalation 50 mg QD	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Dose Escalation 100 mg QD	0 of 1 (0%)	1 of 1 (100%)	0 of 1
Dose Escalation 200 mg QD	2 of 2 (100%)	2 of 2 (100%)	0 of 2
Dose Escalation 400 mg QD	2 of 10 (20%)	10 of 10 (100%)	2 of 10
Dose Escalation 800 mg QD	8 of 18 (44.4%)	18 of 18 (100%)	7 of 18
Dose Escalation 800 mg QD NF	1 of 13 (7.7%)	13 of 13 (100%)	2 of 13
Dose Escalation 1000 mg QD	1 of 7 (14.3%)	7 of 7 (100%)	2 of 7
Dose Escalation 1200 mg QD	1 of 6 (16.7%)	6 of 6 (100%)	1 of 6
Dose Escalation 400 mg BID	1 of 4 (25%)	4 of 4 (100%)	1 of 4
Dose Escalation 600 mg BID	2 of 6 (33.3%)	6 of 6 (100%)	1 of 6
Dose Escalation 800 mg BID	3 of 5 (60%)	5 of 5 (100%)	0 of 5
Safety Expansion 800 mg QD	4 of 17 (23.5%)	17 of 17 (100%)	10 of 17

Limitations and caveats (from the sponsor): Study terminated early. Phase 2 was not conducted. Limited data collection was performed for this study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundErika Paige Hamilton, Manish R. Patel, Jordi Rodon, David S. Hong, Alison M. Schram, Pasi A. Janne, Patricia LoRusso, Jasgit C. Sachdev, Sai Hong Ou, Elizabeth A Buck, Matthew O'Connor, Nigel Waters, Karsten Witt, Carl Cook. Masterkey-01: Phase I/II, open-label multicenter study to assess safety, tolerability, pharmacokinetics, and antitumor activity of BDTX-189, an inhibitor of allosteric ErbB mutations, in patients with advanced solid malignancies. J Clin Oncol 38: 2020 (suppl; abstr TPS3665)
Individual participant dataSharing planned: No

Related trials for Solid Tumor

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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

38 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BDTX-189 in people with Solid Tumor, run by Black Diamond Therapeutics, Inc. at 38 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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: stopped early, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Spain, France, Denmark. 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Dose Limiting Toxicities as a Determinant of the Recommended Phase 2 Dose (RP2D) (time frame: After the first dose of treatment for up to 21 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04209465, which also lists 1 linked publication.

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 17 Apr 2025.