ENV-501 for Breast Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial requires that you stop taking any anti-tumor drugs, investigational drugs, and certain other medications like strong CYP3A4 inhibitors or inducers, and OATP1B inhibitors before starting the study. You should discuss your current medications with the study team to see if they fall into these categories.
What data supports the effectiveness of the drug ENV-501 for breast cancer?
What is the purpose of this trial?
This study is a Phase 1/2, first-in-human, open-label, clinical trial to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of ENV-501 in patients with advanced-stage, relapsed and/or refractory human epidermal growth factor receptor 3 (HER3)-expressing solid tumors. The study consists of 2 phases: a dose escalation phase (Phase 1) and a dose expansion phase (Phase 2).The primary objectives of Phase 1 are to characterize the overall safety and tolerability profile of increasing doses of ENV-501 in patients with advanced-stage solid tumors and identify the recommended Phase 2 dose (RP2D) of ENV-501. During Phase 1, successive cohorts of patients will receive escalating doses of ENV-501. The results of the dose escalation will determine the RP2D and dosing schedule of ENV-501 to be administered in the Phase 2 part of the study. The primary objective of Phase 2 is to evaluate the preliminary clinical efficacy of ENV-501 in dose expansion cohorts.
Research Team
Lisa Lancaster, M.D.
Principal Investigator
Endeavor Biomedicines
Eligibility Criteria
This trial is for patients with advanced-stage solid tumors that express HER3, such as skin cancer, breast cancer, and non-small cell lung cancer. Participants must have relapsed or refractory conditions after previous treatments.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation (Phase 1)
Successive cohorts of patients receive escalating doses of ENV-501 to determine the recommended Phase 2 dose (RP2D)
Dose Expansion (Phase 2)
Evaluate the preliminary clinical efficacy of ENV-501 in dose expansion cohorts
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ENV-501
Find a Clinic Near You
Who Is Running the Clinical Trial?
Endeavor Biomedicines, Inc.
Lead Sponsor