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

ConditionsAdvanced 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 Nasopharyngeal Cancinoma (NPC)Squamous Cell Carcinoma

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorHummingbird Bioscience

About this trial

This is a Phase Ib/II multi-center, open-label study of HMBD-001 in combination with cetuximab with or without docetaxel in participants with advanced Squamous Cell Cancers

Eligibility criteria

Qualifiers

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

Disqualifiers

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