Clinical Trials Logo
  1. Home
  2. Metastatic Breast Cancer
  3. NCT04115306

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

Metastatic Breast Cancer Clinical Trial

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

Clinical 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.

Clinical Trial Description

Combination with fulvestrant (Part 3): This study will prospectively enroll RSK2+ (≥75% nuclear staining with ≥2+ in staining intensity) 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 (500 mg IM, Day 1 and 15 of the first 28-day cycle, then Day 1 of every cycle thereafter) in combination with PMD-026 at the RP2D (200 mg, PO, Q12h) 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. The combination regimen will have a safety lead-in cohort of 6 patients. The SRC will review the safety data after the sixth patient has been treated for at least 28 days. If determined to be safe, up to 14 additional patients will receive the combination for a total of 20 patients. A Bayesian safety monitoring rule will be used to evaluate the rate of DLTs during expansion. Specifically, the rule will be applied after data is available for the 6th DLT-evaluable patient. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04115306
Study type Interventional
Source Phoenix Molecular Designs
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date November 14, 2019
Completion date March 2026
View Details
See also
  Status Clinical Trial Phase
Withdrawn NCT04872608 - A Study of Letrozole, Palbociclib, and Onapristone ER in People With Metastatic Breast Cancer Phase 1
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Completed NCT02506556 - Phosphatidylinositol 3-kinase (PI3K) Alpha iNhibition In Advanced Breast Cancer Phase 2
Recruiting NCT05534438 - A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer Phase 2
Recruiting NCT03368729 - Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer Phase 1/Phase 2
Completed NCT04103853 - Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer Phase 1
Terminated NCT01847599 - Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib N/A
Active, not recruiting NCT03147287 - Palbociclib After CDK and Endocrine Therapy (PACE) Phase 2
Not yet recruiting NCT06062498 - Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer Phase 2
Recruiting NCT05383196 - Onvansertib + Paclitaxel In TNBC Phase 1/Phase 2
Recruiting NCT04095390 - A Phase Ⅱ Trial of Pyrotinib Combination With CDK4/6 Inhibitor SHR6390 in Patients Prior Trastuzumab-treated Advanced HER2-Positive Breast Cancer Phase 2
Active, not recruiting NCT04432454 - Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation Phase 2
Recruiting NCT03323346 - Phase II Trial of Disulfiram With Copper in Metastatic Breast Cancer Phase 2
Recruiting NCT05744375 - Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab Phase 2
Completed NCT02924883 - A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy Phase 2
Completed NCT01881230 - Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer) Phase 2/Phase 3
Completed NCT01942135 - Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3) Phase 3
Active, not recruiting NCT04448886 - Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC Phase 2
Completed NCT01401959 - Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy Phase 2
Terminated NCT04720664 - Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer Phase 2