61 Participants Needed

PMD-026 for Breast Cancer

(Dauntless-1 Trial)

Recruiting at 11 trial locations
PM
BB
PM
Overseen ByPhoenix Molecular Designs PMD
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Phoenix Molecular Designs
Must be taking: Endocrine therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop endocrine therapy at least 15 days before starting PMD-026. Other medications may need to be stopped if they fall under the exclusion criteria, such as recent chemotherapy or investigational therapy.

What safety data exists for PMD-026 in humans?

The research does not provide specific safety data for PMD-026 in humans.12345

Eligibility Criteria

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.

Inclusion Criteria

I am a woman who can have children and have a negative pregnancy test.
I am 18 years old or older.
My breast cancer is triple-negative, has spread, and no standard treatments are effective.
See 11 more

Exclusion Criteria

Your blood pressure is not well controlled, with numbers higher than 180 over 100.
My brain metastases are treated and I've been stable for over 28 days.
I had a minor surgery less than a week ago, but my central catheter was placed without waiting.
See 19 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily dosing of PMD-026 in combination with fulvestrant according to the package insert

6 weeks
Weekly visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants are monitored for overall survival and progression-free survival

Up to 2 years

Treatment Details

Interventions

  • PMD-026
Trial OverviewThe 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.
Participant Groups
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

Phoenix Molecular Designs

Lead Sponsor

Trials
1
Recruited
60+

Findings from Research

Preactivated merocyanine 540 (pMC540) and its active isolate merodantoin significantly inhibited tumor growth in established human breast cancer xenografts, achieving 74% and 84% inhibition respectively in nude mice.
Both compounds demonstrated effectiveness against estrogen-independent breast tumors, indicating their potential as targeted therapies with minimal cytotoxicity to normal cells.
Growth inhibitory effects of pMC540 and merodantoin on established MCF-7 human breast tumor xenografts.Sharma, R., Gulliya, KS.[2013]
The study found that breast cancer patients treated with selective estrogen receptor modulators (SERMs) had a significantly higher incidence of uterine malignant mixed Müllerian tumors (S-uMMMTs), with a 6.35-fold increase compared to those not treated with SERMs.
Despite the increased incidence of S-uMMMTs in SERM-treated patients, the clinicopathologic features and overall survival rates were similar across S-uMMMTs, non-SERM associated uMMMTs, and de novo uMMMTs, suggesting that while SERMs may contribute to tumor development, they do not significantly alter the disease characteristics or prognosis.
Uterine Malignant Mixed Müllerian Tumors Following Treatment with Selective Estrogen Receptor Modulators in Patients with Breast Cancer: A Report of 13 Cases and Their Clinicopathologic Characteristics.Jeong, BK., Sung, CO., Kim, KR.[2020]
In a study of 278 breast cancer patients treated with tamoxifen, those with less functional CYP2D6 enzyme variants (heterozygous extensive/intermediate and poor metabolizers) were significantly less likely to experience a greater than 10% reduction in percent mammographic density (PMD), which is linked to breast cancer risk and prognosis.
The results suggest that genetic variations in the CYP2D6 gene may influence how effectively tamoxifen reduces PMD, indicating that genetic testing could help predict treatment responses in breast cancer patients.
Association of CYP2D6 metabolizer status with mammographic density change in response to tamoxifen treatment.Li, J., Czene, K., Brauch, H., et al.[2021]

References

Growth inhibitory effects of pMC540 and merodantoin on established MCF-7 human breast tumor xenografts. [2013]
Uterine Malignant Mixed Müllerian Tumors Following Treatment with Selective Estrogen Receptor Modulators in Patients with Breast Cancer: A Report of 13 Cases and Their Clinicopathologic Characteristics. [2020]
Association of CYP2D6 metabolizer status with mammographic density change in response to tamoxifen treatment. [2021]
CYP2D6 and adjuvant tamoxifen: possible differences of outcome in pre- and post-menopausal patients. [2022]
Influence of CYP2D6-genotype on tamoxifen efficacy in advanced breast cancer. [2013]