Conditions

Advanced Squamous Cell Cancer
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

Purpose of the study

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. NCT05910827 

Official Title

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. 

Who is eligible to participate?

• 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 

Register your interest

To register your interest or find out more information about this clinical trial, please email: enquiries@gallipoliresearch.org.au. 

Study location

Gallipoli Medical Research, Greenslopes Private Hospital, Brisbane