ENV-501 for Breast Cancer

Recruiting at 3 trial locations

Overseen By Endeavor Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Endeavor Biomedicines, Inc.

Must not be taking: CYP3A4 inhibitors, CYP3A4 inducers, OATP1B inhibitors

Disqualifiers: Infections, Pneumonitis, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

180 Participants Needed

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?

The combination of bevacizumab with taxane drugs has shown to improve progression-free survival and objective remission in certain types of breast cancer, although it did not extend overall survival. This suggests that similar treatments might help control the disease for a period of time. ^{1 2 3 4 5}

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

Contraceptive requirements for women of childbearing potential (WOCBP) and sexually active males

Willing and able to provide signed written informed consent before any study-related screening procedures are performed

Agreement by females to not donate eggs (ova, oocytes) for the purposes of assisted reproduction and not to breastfeed or plan to become pregnant, and agreement by males to not donate sperm or plan to father a child

Exclusion Criteria

Primary immune deficiency

Known/suspected hypersensitivity against ENV-501, human or humanized immunoglobulin Gs (IgGs), or their ingredients

Known seropositivity for HIV, HBV, or HCV

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Phase 1)

Successive cohorts of patients receive escalating doses of ENV-501 to determine the recommended Phase 2 dose (RP2D)

6 months

Every 3 weeks

Dose Expansion (Phase 2)

Evaluate the preliminary clinical efficacy of ENV-501 in dose expansion cohorts

6 months

Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• ENV-501

Trial Overview ENV-501 is being tested in this two-phase clinical trial. Phase 1 will find the safest dose by gradually increasing it among groups of patients. Phase 2 will use this established dose to assess how effective ENV-501 is against these cancers.

Participant Groups

Group I: ENV-501 Experimental Treatment 1 Intervention

ENV-501 intravenous injection once every 3 weeks; successive cohorts will receive escalating doses of ENV-501 until the RP2D is reached

Who Is Running the Clinical Trial?

Endeavor Biomedicines, Inc.

Lead Sponsor

Trials

4

Recruited

310+

Findings from Research

Nurse practitioners are crucial in managing breast cancer, particularly in prevention, early detection, and treatment, emphasizing the importance of health assessments as part of their core competencies.

The review of five case studies shows that eribulin mesylate can be an effective treatment option for women with metastatic breast cancer who have previously undergone at least two chemotherapy regimens, highlighting its role in managing adverse events and improving therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncology nursing support for safe and effective use of eribulin in metastatic breast cancer. Donovan, D., Urquhart, L., Hopkins, U., et al.[2021]

In a study of 1206 women with HER2-negative operable breast cancer, adding bevacizumab (bev) to neoadjuvant chemotherapy resulted in a higher rate of early surgical complications (25.4% vs. 18.9%), although most complications were mild (grade 1-2).

While bev increased the incidence of long-term noninfectious wound complications (11.8% vs. 5.1%), the occurrence of serious complications requiring surgical intervention was low, suggesting that bev can be used safely in the perioperative setting with appropriate precautions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect on Surgical Complications of Bevacizumab Added to Neoadjuvant Chemotherapy for Breast Cancer: NRG Oncology/NSABP Protocol B-40. Bear, HD., Tang, G., Rastogi, P., et al.[2018]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy and safety of adding an agent to bevacizumab/taxane regimens for the first-line treatment of Her2-negative patients with locally recurrent or metastatic breast cancer: results from seven randomized controlled trials. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Advances in Targeted Therapy for Breast Cancer. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Oncology nursing support for safe and effective use of eribulin in metastatic breast cancer. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

The Effect on Surgical Complications of Bevacizumab Added to Neoadjuvant Chemotherapy for Breast Cancer: NRG Oncology/NSABP Protocol B-40. [2018]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Endocrine Therapy-Based Strategies for Metastatic Breast Cancer with Different Endocrine Sensitivity Statuses: A Systematic Review and Network Meta-Analysis. [2022]