Brief 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 advancedat a late stage, far along or metastatic squamous Non-Small Cell Lung Cancers, and HMBD-001 in combination with cetuximab in participants with advanced Squamous Cell Cancers.
Intervention / Treatment
- Drug: HMBD-001
- Drug: Docetaxel
- Drug: Cetuximab
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 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 biopsyremoval of a section of tissue to analyse for cancer cells 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.