A Phase 1b Study to Evaluate HMBD-001 in Combination With Docetaxel With or Without Cetuximab in Participants With Advanced Squamous Non-Small Cell Lung Cancers, and HMBD-001 in Combination With Cetuximab in Participants With Advanced Squamous Cell Cancers

Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This is a phase 1b multi-center, open-label study of HMBD-001 in combination with docetaxel with or without cetuximab in participants with locally advanced or metastatic squamous Non-Small Cell Lung Cancers, and HMBD-001 in combination with cetuximab in participants with advanced Squamous Cell Cancers

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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 or cervical SCC 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

Locations
Other Locations
Australia
Southern Oncology Clinical Research Unit
RECRUITING
Adelaide
ICON Cancer Centre South Brisbane
WITHDRAWN
Brisbane
Peninsula & South Eastern Haematology and Oncology Group
RECRUITING
Frankston
Greenslopes Private Hospital
RECRUITING
Greenslopes
Cabrini Health
WITHDRAWN
Malvern
Linear Clinical Research
RECRUITING
Perth
GenesisCare North Shore
RECRUITING
Sydney
Westmead Hospital
RECRUITING
Westmead
Republic of Korea
Chungbuk National University Hospital
RECRUITING
Cheongju-si
CHA Bundang Medical Center, CHA University
RECRUITING
Seongnam-si
Korea University Anam Hospital
RECRUITING
Seoul
Severance Hospital
RECRUITING
Seoul
The Catholic University of Korea St. Vincent's Hospital
NOT_YET_RECRUITING
Suwon
Republic of Moldova
The Institute of Oncology, ARENSIA Exploratory Medicine Phase I Unit
RECRUITING
Chisinau
Singapore
National Cancer Centre Singapore
RECRUITING
Singapore
Tan Tock Seng Hospital
RECRUITING
Singapore
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
National Cheng Kung University Hospital
RECRUITING
Tainan City
Taipei Medical University - Shuang Ho Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Contact Information
Primary
Kevin Heller, Dr
k.heller@hummingbirdbio.com
+65 6978 9377
Time Frame
Start Date: 2024-02-05
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 98
Treatments
Experimental: Arm A
Participants receive HMBD-001 with docetaxel. This treatment arm is closed to recruitment.
Experimental: Arm B
Participants receive HMBD-001 with docetaxel plus cetuximab
Experimental: Arm C
Participants receive HMBD-001 with cetuximab
Sponsors
Leads: Hummingbird Bioscience
Collaborators: Merck KGaA, Darmstadt, Germany

This content was sourced from clinicaltrials.gov

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