Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer

NCT04115306 | Recruiting Phase 1 FDA Drug

• 1 other identifier: PMD-026-1-001
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 11

Brief 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.

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; solid tumor; late stage breast cancer/late-stage breast cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  6 weeks

Secondary Outcomes (2)

• Plasma concentration of PMD-026 when administered in combination with fulvestrant

  As determined by PK data

• Preliminary anti-tumor activity of PMD-026 when dosed in combination with fulvestrant

  Until PD or death, up to 2 years

Other Outcomes (2)

• Assess OS

  Throughout study

• Evaluate QT interval and PMD-026 concentrations

  Throughout study

Study Arms (1)

Oral PMD-026 in combination with fulvestrant

EXPERIMENTAL

Daily dosing of PMD-026 with fulvestrant dosing according to package insert

Drug: PMD-026; Drug: fulvestrant

Interventions

PMD-026 DRUG

Investigational Drug

Oral PMD-026 in combination with fulvestrant

fulvestrant DRUG

SERDs

Also known as: Faslodex

Oral PMD-026 in combination with fulvestrant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Phoenix Molecular Designs: lead

Study Sites (11)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

RECRUITING

City of Hope

Duarte, California, 91010, United States

RECRUITING

City of Hope Orange County, Lennar

Irvine, California, 92618, United States

RECRUITING

University of California, Los Angeles (UCLA)

Los Angeles, California, 90095, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

City of Hope Chicago

Zion, Illinois, 60099, United States

RECRUITING

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

RECRUITING

Profound Research

Farmington Hills, Michigan, 48334, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Oncology Consultants

Houston, Texas, 77030, United States

WITHDRAWN

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Central Study Contacts

Phoenix Molecular Designs PMD

CONTACT

(858) 945-6456; clinical@phoenixmd.ca

Joseph Leveque, MD

CONTACT

(858) 945-6456; clinical@phoenixmd.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 4, 2019
• Study Start: November 14, 2019
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)