Testing a new antibody treatment for advanced squamous cell cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Westmead Hospital
  Westmead, New South Wales, Australia Recruiting
• 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
• Linear Clinical Research
  Perth, Western Australia, Australia Recruiting
• The Institute of Oncology, ARENSIA Exploratory Medicine Phase I Unit
  Chisinau, Moldova Recruiting

Study contacts

• Study coordinator: Kevin Heller, Dr
• Email: k.heller@hummingbirdbio.com
• Phone: +65 6978 9377

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing chemotherapy combinations for advanced head and neck cancer

  This study is testing two different chemotherapy combinations to see which one works better for people with advanced head and neck cancer while they also receive radiation therapy.

  Recruiting Phase 2 University of Pittsburgh · Pittsburgh, Pennsylvania · NCT02128906

• Safe use of metformin and naproxen to help prevent cancer in people with Fanconi anemia

  This study tests whether metformin and naproxen can lower the chance of cancer developing in adults with Fanconi anemia.

  Recruiting at 2 sites Phase 1 Rockefeller University · Minneapolis, Minnesota and 1 other locations · NCT07901959

• Toripalimab Plus Cetuximab and Irinotecan for second-line right-sided colon cancer

  This phase II study tests whether a combo of toripalimab, cetuximab, and irinotecan helps adults with second-line, right‑sided, RAS/BRAF wild-type advanced colon cancer.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT07896681

• Iparomlimab and Tuvonralimab With Cetuximab Before Surgery in Resectable Oral Cancer

  In this phase 2 study, patients with locally advanced, resectable oral squamous cell carcinoma will receive a combination of iparomlimab, tuvonralimab, and cetuximab before surgery to see if the treatment is safe and can shrink tumors.

  Recruiting Phase 2 Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Shanghai, Shanghai Municipality · NCT07882888

• Cetuximab bioequivalence test in healthy men

  This study tests whether a cetuximab injection is bioequivalent to Erbitux in healthy men to see if they behave the same in the body.

  Recruiting Phase 1 HC Biopharma Inc. · Haikou, Hainan · NCT07813468

• Nanocrystalline Megestrol Acetate to Help Appetite During Chemoradiotherapy in Nasopharyngeal Carcinoma

  This phase 3 trial tests whether taking nanocrystalline megestrol acetate can help people with nasopharyngeal carcinoma who are receiving chemoradiotherapy to keep their appetite and weight better than placebo.

  Recruiting at 3 sites Phase 3 Sun Yat-sen University · Guangzhou, Guangdong and 2 other locations · NCT07796789

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.