A Phase Ib/II Study of an Anti-HER3 Antibody, HMBD-001, With Cetuximab +/- Docetaxel in Advanced Squamous Cell Cancers

Exclusion Criteria

• •Prior treatment with HMBD-001, docetaxel, cetuximab or any other agent that targets Epidermal Growth Factor Receptor (EGFR) or HER3, including pan-HER inhibitors. Prior treatment with docetaxel is allowed for Arm C
• •* Receipt of prior targeted therapy, including but not limited to those targeting EGFR activating mutations, ALK fusions, ROS rearrangements, RET fusions or mutations, BRAF V600E mutation, MET exon 14 skipping mutation, and/or KRAS G12C mutation
• •* Persistent clinically significant toxicities (Grade ≥2) from previous anti-cancer therapy except for Grade \>2 toxicities that are considered unlikely to put the participant at an increased risk of treatment-related toxicity and/or impact the study results e.g., alopecia
• •* Most recent anti-cancer therapy including radiotherapy at least 4 weeks, or nitrosourea or mitomycin 3 at least 6 weeks, or 5 half-lives whichever is shorter prior to starting the assigned study treatment
• •* Symptomatic primary Central Nervous System (CNS) cancer or metastases unless the symptoms are stable for at least 28 days prior to the first dose of the study drug and any symptoms have returned to baseline
• •* Evidence of abnormal cardiac function
• •* History of uncontrolled allergic reactions and/or known expected hypersensitivity to the study drugs used in the treatment arm to which the participant is to be enrolled into
• •* Any other known active malignancy except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer
• •* Any uncontrolled illness or significant uncontrolled condition(s) requiring systemic treatment
• •* Known Human Immunodeficiency Virus (HIV) infection
• •* Active hepatitis B or hepatitis C infection
• •* Pregnant or breast feeding
• •* COVID 19 infection within 3 months prior to the first dose of the study drug
• •* COVID 19 vaccination within 14 days prior to the first dose of the study drug
• •* Treatment with strong inhibitors or inducers of CYP3A4