Metastatic Breast CancerPhase 1/2Dauntless-1NCT04115306
Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer
A Phase 1/2 study testing PMD-026 and fulvestrant in people with Metastatic Breast Cancer, run by Phoenix Molecular Designs at 10 sites in United States.
Trial summary
The purpose of this study is to test the safety and tolerability of PMD-026 in patients with metastatic breast cancer. PMD-026 is a targeted oral agent designed to kill tumor cells in metastatic breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- PMD-026 and fulvestrant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 10 sitesUnited States
- Study dates
- 14 Nov 2019to Dec 2026
- 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
- RSK2 positive from available archival or fresh tumor tissue (FFPE).
- Histologically or cytologically diagnosed HR+, HER2-
- ESR1 wild type
- Diagnosis of adenocarcinoma of the breast with evidence of either locally advanced disease not amendable to resection or radiation with curative intent or metastatic disease not amendable to curative therapy
- Must be appropriate candidates for endocrine therapy
- Previously received at least 1 line of endocrine therapy for MBC or had recurrence while on adjuvant endocrine therapy for locally advanced breast cancer
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- Discontinued endocrine therapy at least 15 days prior to first dose of PMD-026
- At least 1 measurable target lesion as defined by RECIST v1.1
- Progression on or after treatment with a CDK4/6 inhibitor in combination with endocrine therapy inhibitor in the locally advanced or metastatic setting
- Adequate hematologic, hepatic, and renal function as assessed by laboratory parameters
- Toxicity related to prior therapy resolved to at least Grade 1 (alopecia excepted) or to at least Grade 2 with prior approval of the Medical Monitor
Who cannot join
- Prior chemotherapy
- ESR1 mutations
- ≤14 days from biological or investigational therapy
- Presence of visceral crisis or uncontrolled visceral disease for which chemotherapy would be indicated
- Central nervous system metastases, unless appropriately treated and neurologically stable
- History of leptomeningeal metastases
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- Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy
- Known hepatitis B or hepatitis C infection
- Known HIV-positive with CD4+ cell counts <350 cells/μL
- Known HIV-positive with a history of an AIDS-defining opportunistic infection
- History of clinically significant cardiovascular abnormalities, including QTcF interval >460 msec (using Fridericia's formula)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Ohio State University
Columbus, Ohio, 43210
City of Hope
Duarte, California, 91010
Profound Research
Farmington Hills, Michigan, 48334
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
City of Hope Orange County, Lennar
Irvine, California, 92618
University of California, Los Angeles (UCLA)
Los Angeles, California, 90095
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
Moffitt Cancer Center
Tampa, Florida, 33612
City of Hope Chicago
Zion, Illinois, 60099
About this study
Official title: Ph 1/1b/2 Multicenter, Open-Label, FIH Dose Esc & Dose Exp Study to Assess Safety and Tolerability of Orally Administered PMD-026 as a Single Agent and in Combination in Patients With Metastatic or Locally Advanced (Inoperable) RSK2+ Breast Cancer
The purpose of this study is to test the safety and tolerability of PMD-026 in patients with metastatic breast cancer. PMD-026 is a targeted oral agent designed to kill tumor cells in metastatic breast cancer.
Read the detailed description
Combination with fulvestrant (Part 3):
This study will enroll RSK2+, HR+, and human epidermal growth factor receptor 2 negative (HER2-) patients to evaluate PMD-026 in combination with a standard dose and schedule of fulvestrant. Fulvestrant will be dosed per the package insert in combination with PMD-026 at the RP2D determined in the monotherapy phase of the study. Up to 20 patients will be enrolled with locally advanced or metastatic HR+/HER2- breast cancer previously treated with a CDK4/6 inhibitor in combination with endocrine therapy.
- Conditions
- Metastatic Breast Cancer
- Being tested
- PMD-026, fulvestrant
- Keywords
- invasive breast cancer, PR-negative breast cancer, HER2-negative breast cancer, Breast cancer, Breast malignancy, breast malignancies, metastatic breast cancer, advanced breast cancer, solid tumor, late stage breast cancer/late-stage breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMD-026Drug
Investigational Drug
fulvestrantDrug
Also called Faslodex
SERDs
| Study group | Role | What they receive |
|---|---|---|
| Oral PMD-026 in combination with fulvestrant | Experimental | Daily dosing of PMD-026 with fulvestrant dosing according to package insert Receives: Drug: PMD-026; Drug: fulvestrant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of PMD-026 in combination with fulvestrant in patients with HR+/HER2- previously treated breast cancer
Incidence of AEs, DLTs, SAEs. Changes in laboratory, vital signs, and ECG values.
Measured: 6 weeks
Secondary outcomes (2)
Plasma concentration of PMD-026 when administered in combination with fulvestrant
The plasma concentration will be measured as part of pharmacokinetic (PK) testing.
Measured: As determined by PK data
Preliminary anti-tumor activity of PMD-026 when dosed in combination with fulvestrant
ORR, DOR, DCR, PFS
Measured: Until PD or death, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2019
- Study start14 Nov 2019
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phoenix Molecular Designs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04115306
- Sponsor's protocol ID
- PMD-026-1-001
- Acronym
- Dauntless-1
- Status last verified
- Apr 2026
- First submitted
- 2 Oct 2019
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ph 1/1b/2 Multicenter, Open-Label, FIH Dose Esc & Dose Exp Study to Assess Safety and Tolerability of Orally Administered PMD-026 as a Single Agent and in Combination in Patients With Metastatic or Locally Advanced (Inoperable) RSK2+ Breast Cancer
- ClinicalTrials.gov ID
- NCT04115306
- Acronym / sponsor ID
- Dauntless-1 / PMD-026-1-001
- Conditions
- Metastatic Breast Cancer
- Keywords
- invasive breast cancer, PR-negative breast cancer, HER2-negative breast cancer, Breast cancer, Breast malignancy, breast malignancies, metastatic breast cancer, advanced breast cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Phoenix Molecular DesignsIndustry (pharma, biotech, devices)
- Study start
- 14 Nov 2019 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Oct 2019 (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.
The purpose of this study is to test the safety and tolerability of PMD-026 in patients with metastatic breast cancer. PMD-026 is a targeted oral agent designed to kill tumor cells in metastatic breast cancer.
Detailed description
Combination with fulvestrant (Part 3):
This study will enroll RSK2+, HR+, and human epidermal growth factor receptor 2 negative (HER2-) patients to evaluate PMD-026 in combination with a standard dose and schedule of fulvestrant. Fulvestrant will be dosed per the package insert in combination with PMD-026 at the RP2D determined in the monotherapy phase of the study. Up to 20 patients will be enrolled with locally advanced or metastatic HR+/HER2- breast cancer previously treated with a CDK4/6 inhibitor in combination with endocrine therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral PMD-026 in combination with fulvestrant | Experimental | Drug: PMD-026, Drug: fulvestrantDaily dosing of PMD-026 with fulvestrant dosing according to package insert |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- RSK2 positive from available archival or fresh tumor tissue (FFPE).
- Histologically or cytologically diagnosed HR+, HER2-
- ESR1 wild type
- Diagnosis of adenocarcinoma of the breast with evidence of either locally advanced disease not amendable to resection or radiation with curative intent or metastatic disease not amendable to curative therapy
- Must be appropriate candidates for endocrine therapy
Key exclusion criteria (11 listed)
- Prior chemotherapy
- ESR1 mutations
- ≤14 days from biological or investigational therapy
- Presence of visceral crisis or uncontrolled visceral disease for which chemotherapy would be indicated
- Central nervous system metastases, unless appropriately treated and neurologically stable
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 |
|---|---|---|
| PMD-026Investigational Drug | Drug | Oral PMD-026 in combination with fulvestrant |
| fulvestrantAlso: FaslodexSERDs | Drug | Oral PMD-026 in combination with fulvestrant |
Primary outcome
Safety and tolerability of PMD-026 in combination with fulvestrant in patients with HR+/HER2- previously treated breast cancer
Time frame: 6 weeks
Incidence of AEs, DLTs, SAEs. Changes in laboratory, vital signs, and ECG values.
2 secondary outcomes
Plasma concentration of PMD-026 when administered in combination with fulvestrant
Time frame: As determined by PK data
Preliminary anti-tumor activity of PMD-026 when dosed in combination with fulvestrant
Time frame: Until PD or death, up to 2 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 16 Jul 2026.
- Individual participant dataSharing planned: No
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PMD-026 and fulvestrant in people with Metastatic Breast Cancer, run by Phoenix Molecular Designs at 10 sites in United States.
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 11 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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?
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?
Safety and tolerability of PMD-026 in combination with fulvestrant in patients with HR+/HER2- previously treated breast cancer (time frame: 6 weeks). 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 16 Jul 2026.