Testing a new antibody treatment for 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

This study is testing a new antibody treatment combined with chemotherapy for people with advanced squamous cell cancers that haven't responded to standard therapies.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 398 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hummingbird Bioscience (industry)
• Drugs / interventions: cetuximab
• Locations: 20 sites (Sydney, New South Wales and 19 other locations)
• Trial ID: NCT05910827 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and efficacy of HMBD-001, an anti-HER3 antibody, in combination with docetaxel and cetuximab for patients with advanced squamous non-small cell lung cancers and other advanced squamous cell carcinomas. The study is designed as a phase 1b multi-center, open-label trial, focusing on participants whose cancer has progressed despite standard treatments. Patients will receive either HMBD-001 with docetaxel alone or in combination with cetuximab, or HMBD-001 with cetuximab, depending on their specific cancer type and treatment history.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with advanced squamous non-small cell lung cancer or other specified advanced squamous cell carcinomas who have exhausted standard treatment options.

Not a fit: Patients with early-stage cancers or those who have not yet received any systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced squamous cell cancers that have limited treatment alternatives.

How similar studies have performed: Other studies have shown promise with similar antibody treatments, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Ability to understand and be willing to sign an informed consent form

  * Males and females aged over 18 years (or having reached the age of majority according to local laws if the age of majority is \> 18 years of age)
  * Eastern Cooperative Oncology Group (ECOG) status of 0 to 1
  * Arm B only: Locally advanced or metastatic squamous non-small cell lung cancer for which all available standard of care treatment options have been exhausted or refused and for which at least one lesion is measurable
  * Arm C only: Advanced or metastatic sqNSCLC, HNSCC, ESCC, CSCC, cervical SCC, NPC and other SCCs with at least one prior line of systemic therapy,
  * Have an estimated life expectancy of at least 3 months
  * Participants must be willing to provide a fresh tumor biopsy sample
  * Have adequate organ function
  * Females must be non-pregnant and non-lactating, willing to use a highly effective method of contraception from screening until study completion or be either surgically sterile or post-menopausal
  * Males must be surgically sterile, abstinent, or if engaged in sexual relations with a woman of child-bearing potential, the participant and his partner must be surgically sterile or using an acceptable, highly effective contraceptive method from screening until study completion

Exclusion Criteria:

* Prior treatment with HMBD-001, docetaxel, cetuximab or any other agent that targets Epidermal Growth Factor Receptor (EGFR) or HER3, including pan-HER inhibitors. Prior treatment with docetaxel is allowed for Arm C

  * Receipt of prior targeted therapy, including but not limited to those targeting EGFR activating mutations, ALK fusions, ROS rearrangements, RET fusions or mutations, BRAF V600E mutation, MET exon 14 skipping mutation, and/or KRAS G12C mutation
  * Persistent clinically significant toxicities (Grade ≥2) from previous anti-cancer therapy except for Grade \>2 toxicities that are considered unlikely to put the participant at an increased risk of treatment-related toxicity and/or impact the study results e.g., alopecia
  * Most recent anti-cancer therapy including radiotherapy at least 4 weeks, or nitrosourea or mitomycin 3 at least 6 weeks, or 5 half-lives whichever is shorter prior to starting the assigned study treatment
  * Symptomatic primary Central Nervous System (CNS) cancer or metastases unless the symptoms are stable for at least 28 days prior to the first dose of the study drug and any symptoms have returned to baseline
  * Evidence of abnormal cardiac function
  * History of uncontrolled allergic reactions and/or known expected hypersensitivity to the study drugs used in the treatment arm to which the participant is to be enrolled into
  * Any other known active malignancy except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer
  * Any uncontrolled illness or significant uncontrolled condition(s) requiring systemic treatment
  * Known Human Immunodeficiency Virus (HIV) infection
  * Active hepatitis B or hepatitis C infection
  * Pregnant or breast feeding
  * COVID 19 infection within 3 months prior to the first dose of the study drug
  * COVID 19 vaccination within 14 days prior to the first dose of the study drug
  * Treatment with strong inhibitors or inducers of CYP3A4

Where this trial is running

Sydney, New South Wales and 19 other locations

• GenesisCare North Shore — Sydney, New South Wales, Australia (WITHDRAWN)
• Westmead Hospital — Westmead, New South Wales, Australia (RECRUITING)
• ICON Cancer Centre South Brisbane — Brisbane, Queensland, Australia (WITHDRAWN)
• Greenslopes Private Hospital — Greenslopes, Queensland, Australia (RECRUITING)
• Southern Oncology Clinical Research Unit — Adelaide, South Australia, Australia (RECRUITING)
• Peninsula & South Eastern Haematology and Oncology Group — Frankston, Victoria, Australia (RECRUITING)
• Cabrini Health — Malvern, Victoria, Australia (WITHDRAWN)
• Linear Clinical Research — Perth, Western Australia, Australia (RECRUITING)
• The Institute of Oncology, ARENSIA Exploratory Medicine Phase I Unit — Chisinau, Moldova (RECRUITING)
• National Cancer Centre Singapore — Singapore, Singapore (RECRUITING)
• Tan Tock Seng Hospital — Singapore, Singapore (RECRUITING)
• Chungbuk National University Hospital — Cheongju-si, South Korea (RECRUITING)
• CHA Bundang Medical Center, CHA University — Seongnam-si, South Korea (RECRUITING)
• Korea University Anam Hospital — Seoul, South Korea (RECRUITING)
• Severance Hospital — Seoul, South Korea (RECRUITING)
• The Catholic University of Korea St. Vincent's Hospital — Suwon, South Korea (RECRUITING)
• Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan (RECRUITING)
• National Cheng Kung University Hospital — Tainan, Taiwan (RECRUITING)
• Taipei Medical University - Shuang Ho Hospital — Taipei, Taiwan (RECRUITING)
• Taipei Veterans General Hospital — Taipei, Taiwan (RECRUITING)

Study contacts

• Study coordinator: Kevin Heller, Dr

Conditions: Advanced or Metastatic Squamous Non-Small Cell Lung Cancer, Advanced Head and Neck Squamous Cell Carcinoma, Advanced Esophageal Squamous Cell Carcinoma, Cervical Squamous Cell Carcinoma, Advanced Cutaneous Squamous Cell Carcinoma, Nasopharyngeal Cancinoma, Squamous Cell Carcinoma, NSCLC