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Targeted Therapy

PMD-026 for Breast Cancer (Dauntless-1 Trial)

Phase 1 & 2
Recruiting
Research Sponsored by Phoenix Molecular Designs
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Females of childbearing potential must have a negative serum pregnancy test
Age ≥ 18 years
Must not have
History of clinically significant cardiovascular abnormalities including: Congestive heart failure (NYHA classification ≥ 3 in within 6 months of first dose of PMD-026, Unstable angina pectoris, Myocardial infarction within 12 months of study entry, Arrhythmias requiring continued treatment (controlled atrial fibrillation allowed), QTcF interval > 460 msec (using Fridericia's formula)
Central nervous system metastases, unless appropriately treated and neurologically stable for ≥ 28 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until pd or death, up to 2 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new cancer drug to see if it is safe and works well against breast cancer cells.

Who is the study for?
Adults with metastatic breast cancer, specifically triple-negative type that's worsened after standard treatments. Participants must have acceptable organ function and blood counts, not be pregnant or breastfeeding, agree to use contraception, and can't have certain infections or uncontrolled high blood pressure.
What is being tested?
The trial is testing PMD-026, an oral medication aimed at destroying tumor cells in patients with advanced breast cancer. It examines the drug's safety and how well patients tolerate it. The study involves two parts: dose escalation to find a safe dosage and dose expansion to test its effects further.
What are the potential side effects?
While specific side effects of PMD-026 are not listed here, common ones for cancer drugs include nausea, fatigue, diarrhea, risk of infection due to low blood cell counts, liver issues (elevated enzymes), kidney problems (changes in creatinine levels), and potential heart complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman who can have children and have a negative pregnancy test.
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I am 18 years old or older.
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My breast cancer is triple-negative, has spread, and no standard treatments are effective.
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I agree not to donate sperm during and for 30 days after the study.
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I can take care of myself but might not be able to do heavy physical work.
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My breast cancer has spread and worsened after treatment, with no other beneficial standard treatments available.
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I am a male who is either surgically sterile or will use contraception during and 30 days after the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have serious heart issues, including recent heart failure, unstable angina, heart attack, arrhythmias needing treatment, or a long QTcF interval.
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My brain metastases are treated and I've been stable for over 28 days.
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I have been diagnosed with Hepatitis B or C.
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I have a history of cancer spreading to the lining of my brain and spinal cord.
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I do not have any ongoing serious infections requiring treatment.
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I had targeted radiation for symptom relief within the last week.
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It has been less than 28 days since my major surgery.
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I am not taking any medications that affect my heart's rhythm.
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I do not have a serious infection or health condition that would prevent me from receiving treatment.
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I am not taking medication that strongly affects liver enzyme activity.
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I am taking medication that interacts with a specific protein in my body.
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I am not taking any medications that interact with MATE2K.
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I do not have severe stomach or bowel problems that could affect medication absorption.
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I do not have any other cancers that need treatment within a year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until pd or death, up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and until pd or death, up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and tolerability of PMD-026 in combination with fulvestrant in patients with HR+/HER2- previously treated breast cancer
Secondary study objectives
Plasma concentration of PMD-026 when administered in combination with fulvestrant
Preliminary anti-tumor activity of PMD-026 when dosed in combination with fulvestrant
Other study objectives
Assess OS
Assess gene expression
Evaluate QT interval and PMD-026 concentrations

Side effects data

From 2021 Phase 3 trial • 693 Patients • NCT02028507
63%
Neutrophil count decreased
51%
Fatigue
37%
Hypertension
25%
Nausea
23%
Weight loss
19%
Back pain
17%
Headache
17%
Diarrhea
17%
Mucositis
16%
Weight gain
15%
Vomiting
13%
Hypothermia
13%
Arthralgia
12%
Anorexia
12%
Alopecia
11%
Anemia
11%
Cough
11%
Upper respiratory infection
10%
Obesity
10%
Flu like symptoms
9%
Pain in extremity
9%
Constipation
8%
Fever
7%
Bone pain
7%
Dizziness
7%
Dyspepsia
7%
Hot flashes
7%
Pruritus
5%
Pain
5%
Dysgeusia
3%
Abdominal pain
3%
Respiratory infection
3%
Nail disorder
1%
Spinal cord compression
1%
Heart failure
1%
Pleural effusion
1%
Ascites
1%
Breast infection
1%
Dyspnea
1%
Gallbladder infection
1%
Dislocation of hip
1%
Renal failure
1%
Bronchial infection
1%
Urinary tract infection
1%
Thromboembolic event
1%
Osteonecrosis of jaw
1%
Palmar-plantar erythrodysesthesia syndrome
1%
Cholecystitis acute
1%
Gastrointestinal infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 2: Palbociclib Plus Fulvestrant
Cohort 1 and 2: Capecitabine
Cohort 1: Palbociclib Plus Exemestane

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Oral PMD-026 in combination with fulvestrantExperimental Treatment2 Interventions
Daily dosing of PMD-026 with fulvestrant dosing according to package insert
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
fulvestrant
2012
Completed Phase 3
~2000

Find a Location

Who is running the clinical trial?

Phoenix Molecular DesignsLead Sponsor

Media Library

PMD-026 (Targeted Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04115306 — Phase 1 & 2
Breast Cancer Research Study Groups: Oral PMD-026 in combination with fulvestrant
Breast Cancer Clinical Trial 2023: PMD-026 Highlights & Side Effects. Trial Name: NCT04115306 — Phase 1 & 2
PMD-026 (Targeted Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04115306 — Phase 1 & 2
~10 spots leftby Dec 2025
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