RecruitingPhase 1Phase 2NCT05910827

A Phase Ib/II Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +/- Docetaxel in Advanced Squamous Cell Cancers

A Phase Ib/II Study to Evaluate HMBD-001 in Combination With Cetuximab, With or Without Docetaxel in Participants With Advanced Squamous Cell Carcinomas


Sponsor

Hummingbird Bioscience

Enrollment

398 participants

Start Date

Feb 5, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase Ib/II multi-center, open-label study of HMBD-001 in combination with cetuximab with or without docetaxel in participants with advanced Squamous Cell Cancers


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new antibody drug called HMBD-001 (which targets a cancer-promoting protein called HER3) in combination with chemotherapy (docetaxel) and/or another targeted drug (cetuximab) in people with advanced squamous cell cancers including lung cancer, head and neck cancer, esophageal cancer, skin cancer, or cervical cancer. **You may be eligible if...** - You are 18 or older with advanced squamous cell cancer (lung, head and neck, esophageal, skin, or cervical) - You are in good general health (ECOG 0–1) - All standard treatments have been exhausted or refused - You have at least one measurable tumor - Your life expectancy is at least 3 months - You are willing to provide a fresh tumor biopsy sample **You may NOT be eligible if...** - You have previously received HMBD-001, docetaxel (for the lung cancer arm), cetuximab, or any HER2/HER3/EGFR-targeting drug (with some exceptions) - You have had a recent COVID-19 infection (within 3 months) or vaccination (within 14 days) - You are pregnant or breastfeeding - You have active HIV, hepatitis B or C - You have symptomatic brain metastases - You take strong inhibitors or inducers of a liver enzyme called CYP3A4 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHMBD-001

HMBD-001 is a humanized Immunoglobulin G1 (IgG1) anti-Human Epidermal Growth Factor Receptor 3(HER3) monoclonal antibody (mAb). It is administered intravenously (IV) weekly

DRUGDocetaxel

Docetaxel 75 mg/m\^2 or 60 mg/m IV once every 3 weeks

DRUGCetuximab

Cetuximab 250 mg/m\^2 weekly, with or without 400 mg/m\^2 IV loading dose at C1D1


Locations(20)

GenesisCare North Shore

Sydney, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

ICON Cancer Centre South Brisbane

Brisbane, Queensland, Australia

Greenslopes Private Hospital

Greenslopes, Queensland, Australia

Southern Oncology Clinical Research Unit

Adelaide, South Australia, Australia

Peninsula & South Eastern Haematology and Oncology Group

Frankston, Victoria, Australia

Cabrini Health

Malvern, Victoria, Australia

Linear Clinical Research

Perth, Western Australia, Australia

The Institute of Oncology, ARENSIA Exploratory Medicine Phase I Unit

Chisinau, Moldova

National Cancer Centre Singapore

Singapore, Singapore

Tan Tock Seng Hospital

Singapore, Singapore

Chungbuk National University Hospital

Cheongju-si, South Korea

CHA Bundang Medical Center, CHA University

Seongnam-si, South Korea

Korea University Anam Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

The Catholic University of Korea St. Vincent's Hospital

Suwon, South Korea

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

Taipei Medical University - Shuang Ho Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05910827


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