Actively Recruiting
A Phase Ib/II Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +/- Docetaxel in Advanced Squamous Cell Cancers
Led by Hummingbird Bioscience · Updated on 2026-04-15
398
Participants Needed
20
Research Sites
199 weeks
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
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
CONDITIONS
Official 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 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 with at least one measurable lesion and no remaining standard treatment options
- Arm C only: Advanced or metastatic squamous cell carcinoma (including sqNSCLC, HNSCC, ESCC, CSCC, cervical SCC, NPC, and other SCCs) 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 and non-lactating, willing to use highly effective contraception or be surgically sterile or post-menopausal
- Males must be surgically sterile, abstinent, or if sexually active with a woman of child-bearing potential, both must use acceptable effective contraception from screening until study completion
You will not qualify if you...
- Prior treatment with HMBD-001, docetaxel, cetuximab, or agents targeting EGFR or HER3, except prior docetaxel allowed for Arm C
- Prior targeted therapy for EGFR mutations, ALK fusions, ROS rearrangements, RET fusions/mutations, BRAF V600E mutation, MET exon 14 skipping, or KRAS G12C mutation
- Persistent significant toxicities (Grade ≥2) from previous cancer therapy, except mild ones unlikely to increase risk
- Recent anti-cancer therapy or radiotherapy within specified 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 known hypersensitivity to study drugs
- Any other active malignancy except treated cervical intraepithelial neoplasia or non-melanoma skin cancer
- Uncontrolled illness or significant conditions needing systemic treatment
- Known HIV infection
- Active hepatitis B or C infection
- Pregnant or breastfeeding
- COVID-19 infection within 3 months prior 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
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
CONTACT
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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