ENV-501 for Breast Cancer

Recruiting at 5 trial locations

Overseen By Hummingbird Bioscience 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, ENV-501, to determine its safety and effectiveness for individuals with certain advanced cancers that have returned or do not respond to treatment. The focus is on tumors that express HER3, a protein found in some cancers, such as breast and lung cancer. Participants should have HER3-positive tumors and have exhausted standard treatments without success. The trial will begin by testing different doses to identify the optimal one and then evaluate its effectiveness against the cancer. This offers a chance to try a new therapy when other options have failed. As a Phase 1 trial, the research aims to understand how the treatment works in people, providing participants the opportunity to be among the first to receive this new therapy.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that HMBD-501, the treatment in this study, is a new drug designed to target specific cancer cells. Early animal studies suggest that HMBD-501 might slow tumor growth in lung and breast cancer, indicating potential promise for humans.

However, since this is the first time HMBD-501 is tested in humans, information on its safety for people remains limited. The main goal of the current study is to assess tolerance and determine the best dose. In these early stages, researchers focus on gradually increasing the dose to observe patient reactions. They closely monitor for any side effects to ensure safety.

In summary, while animal studies are promising, human safety data is still being collected. Participants in this trial help researchers learn more about HMBD-501's safety and its potential to treat cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about HMBD-501 for breast cancer because it offers a novel approach compared to current treatments like chemotherapy and hormone therapy. Unlike these standard options, HMBD-501 is administered via intravenous injection every three weeks and features an innovative mechanism that targets cancer cells directly, potentially with fewer side effects. This direct targeting could mean better effectiveness and a more personalized treatment experience for patients, making it a promising option in the fight against breast cancer.

What evidence suggests that ENV-501 might be an effective treatment for breast cancer?

Research has shown that ENV-501, also known as HMBD-501, might help stop tumor growth in cancers with the HER3 protein, such as breast cancer. Laboratory studies have found that HMBD-501 is more effective at stopping tumor growth than other similar treatments. This treatment targets the HER3 protein, which often contributes to cancer growth and spread. Early animal studies showed promising results, particularly in breast and lung cancer models. Although information from human studies remains limited, these findings suggest that ENV-501 could be a promising new treatment option for some cancer patients. ^{1 2 3 4 6}

Who Is on the Research Team?

Lisa Lancaster, M.D.

Principal Investigator

Endeavor Biomedicines

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: HMBD-501 Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Endeavor Biomedicines, Inc.

Lead Sponsor

Trials

4

Recruited

310+

Hummingbird Bioscience

Lead Sponsor

Trials

4

Recruited

560+

Published Research Related to This Trial

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06956690

Study Details | NCT06956690 | A Phase 1/2 Clinical Trial to ... A Phase 1/​2 Clinical Trial to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMBD-501 in Patients With HER3-Expressing Solid ...

2. withpower.com withpower.com/trial/phase-2-skin-neoplasms-4-2025-3b71b

ENV-501 for Breast Cancer 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.

3. aacrjournals.org aacrjournals.org/cancerres/article/83/7_Supplement/2660/721318/Abstract-2660-HMBD-501-a-novel-Fc-engineered

Abstract 2660: HMBD-501 - a novel Fc engineered, exatecan ... In our preclinical studies, HMBD-501 demonstrates superior inhibition of tumor growth compared to other exatecan-based anti-HER3 ADCs, in a ...

4. hummingbirdbioscience.com hummingbirdbioscience.com/wp-content/uploads/2023/04/2023-AACR-HMBD-501-Poster-vF.pdf

HMBD-501 – a novel Fc engineered, exatecan-based next- ... HMBD-501 shows superior tumor growth inhibition in lung and breast cancer. CDX models. (4a) NCI-H358 cells, subcutaneous CDX in male NcR Nude mice. Single 3 ...

5. breastcancertrials.org breastcancertrials.org/bct_nation/mts/mtsResult.seam?zip=94107&yob=0&searchTerm1=enhertu&radiusMiles=-1

MTS Trials - BreastCancerTrials.org Trastuzumab deruxtecan is effective and increases survival in people with HER2 low breast cancers. Trastuzumab deruxtecan (Enhertu®) is an antibody drug ...

6. breastcancertrials.org breastcancertrials.org/bct_nation/mts/mtsResult.seam?zip=94108&gender=na&searchTerm1=enhertu&radiusMiles=-1

MTS Trials - BreastCancerTrials.org Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of valemetostat tosylate, an experimental targeted therapy, with ...