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 consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. 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 Oncologythe study, diagnosis and treatment of cancer Group (ECOG) status of 0 to 1
- Arm B only: Locally advanced or metastatic squamous non-small cell lung cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs 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 screeningtesting for cancer or conditions that can lead to cancer before symptoms appear, also known as cancer 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.