Actively Recruiting
A Phase Ib/II Study to Evaluate HMBD-001 in Combination With Cetuximab, With or Without Docetaxel in Participants With Advanced Squamous Cell Carcinomas
Led by Hummingbird Bioscience · Updated on 2026-05-27
398
Participants Needed
20
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Hummingbird Bioscience
Lead Sponsor
M
Merck KGaA, Darmstadt, Germany
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating HMBD-001, an anti-HER3 antibody, in combination with cetuximab with or without docetaxel for people with advanced squamous cell cancers. This Phase Ib/II, open-label, multi-center study focuses on various types of advanced or metastatic squamous cell carcinomas, including lung, head and neck, esophageal, cervical, cutaneous, and nasopharyngeal cancers. The study aims to assess the safety and effectiveness of these treatments in participants who have limited standard care options. Participants receive HMBD-001 intravenously once a week alongside cetuximab weekly, with or without docetaxel administered every three weeks. There are three treatment arms: one with HMBD-001 plus docetaxel, one with HMBD-001 plus docetaxel and cetuximab (both closed to recruitment), and one with HMBD-001 plus cetuximab. The trial evaluates different combinations to understand their effects on advanced squamous cell cancers. During the study, participants are monitored for adverse events and dose-limiting toxicities. Researchers track progression-free survival up to six months and measure tumor response using established criteria. Blood samples are collected to study the drug's behavior in the body and immune response. The study includes repeated treatment cycles and safety follow-up, with assessments continuing up to 48 months. Participants undergo tumor biopsies and organ function tests to ensure safety and gather comprehensive data.
CONDITIONS
Brief Title
A Phase Ib/II Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +/- Docetaxel in Advanced Squamous Cell Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand and sign an informed consent form
- Male or female aged 18 years or older (or age of majority locally)
- ECOG performance status of 0 to 1
- For Arm B: Locally advanced or metastatic squamous non-small cell lung cancer with measurable lesions and no remaining standard treatment options
- For Arm C: Advanced or metastatic squamous cell carcinomas with at least one prior systemic therapy
- Estimated life expectancy of at least 3 months
- Willingness to provide a fresh tumor biopsy sample
- Adequate organ function
- Females must be non-pregnant, non-lactating, and use effective contraception or be surgically sterile or post-menopausal
- Males must be surgically sterile, abstinent, or use effective contraception if sexually active with women of child-bearing potential
You will not qualify if you...
- Prior treatment with HMBD-001, docetaxel, cetuximab, or any drug targeting EGFR or HER3 (except prior docetaxel allowed for Arm C)
- Previous targeted therapies for specific genetic mutations (EGFR, ALK, ROS, RET, BRAF, MET, KRAS)
- Persistent significant toxicities (Grade 2 or higher) from previous cancer treatments, except alopecia
- Recent anti-cancer therapy within defined timeframes before study treatment
- Symptomatic primary CNS cancer or metastases unless stable for at least 28 days
- Abnormal cardiac function
- History of uncontrolled allergic reactions or hypersensitivity to study drugs
- Active malignancies other than treated cervical intraepithelial neoplasia or non-melanoma skin cancer
- Uncontrolled illnesses requiring systemic treatment
- Known HIV infection
- Active hepatitis B or C infection
- Pregnancy or breastfeeding
- COVID-19 infection within 3 months or vaccination within 14 days prior to first study dose
- Treatment with strong CYP3A4 inhibitors or inducers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation.
Participants receive HMBD-001 in combination with cetuximab, with or without docetaxel, administered intravenously according to their assigned treatment arm.
Weekly visits for HMBD-001 and cetuximab infusions; docetaxel given once every 3 weeks if assigned
Duration - 30 days after last treatment dose
Participants are monitored for safety and adverse events for 30 days after the last dose of study treatment.
1 to 2 visits depending on participant status
Trial Site Locations
Total: 20 locations
1
GenesisCare North Shore
Sydney, New South Wales, Australia, 2065
Withdrawn
2
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
3
ICON Cancer Centre South Brisbane
Brisbane, Queensland, Australia, 4101
Withdrawn
4
Greenslopes Private Hospital
Greenslopes, Queensland, Australia, 4120
Actively Recruiting
5
Southern Oncology Clinical Research Unit
Adelaide, South Australia, Australia, 5042
Actively Recruiting
6
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia
Actively Recruiting
7
Cabrini Health
Malvern, Victoria, Australia, 3144
Withdrawn
8
Linear Clinical Research
Perth, Western Australia, Australia, 6009
Actively Recruiting
9
The Institute of Oncology, ARENSIA Exploratory Medicine Phase I Unit
Chisinau, Moldova
Actively Recruiting
10
National Cancer Centre Singapore
Singapore, Singapore
Actively Recruiting
11
Tan Tock Seng Hospital
Singapore, Singapore
Actively Recruiting
12
Chungbuk National University Hospital
Cheongju-si, South Korea
Actively Recruiting
13
CHA Bundang Medical Center, CHA University
Seongnam-si, South Korea
Actively Recruiting
14
Korea University Anam Hospital
Seoul, South Korea
Actively Recruiting
15
Severance Hospital
Seoul, South Korea
Actively Recruiting
16
The Catholic University of Korea St. Vincent's Hospital
Suwon, South Korea
Actively Recruiting
17
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Actively Recruiting
18
National Cheng Kung University Hospital
Tainan, Taiwan
Actively Recruiting
19
Taipei Medical University - Shuang Ho Hospital
Taipei, Taiwan
Actively Recruiting
20
Taipei Veterans General Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
K
Kevin Heller, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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