OncoMatch/Clinical Trials/NCT05910827
Study of an Anti-HER3 Antibody, HMBD-001, With Docetaxel +/- Cetuximab in Advanced Squamous Non-small Cell Lung Cancers, and HMBD-001 + Cetuximab in Advanced Squamous Cell Cancers
Is NCT05910827 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including HMBD-001 and Docetaxel for advanced or metastatic squamous non-small cell lung cancer.
Treatment: HMBD-001 · Docetaxel · Cetuximab — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Head and Neck Squamous Cell Carcinoma
Esophageal Carcinoma
Biomarker criteria
Excluded: EGFR activating mutation
Receipt of prior targeted therapy, including but not limited to those targeting EGFR activating mutations
Excluded: ALK fusion
Receipt of prior targeted therapy, including but not limited to those targeting...ALK fusions
Excluded: ROS1 rearrangement
Receipt of prior targeted therapy, including but not limited to those targeting...ROS rearrangements
Excluded: RET fusion
Receipt of prior targeted therapy, including but not limited to those targeting...RET fusions or mutations
Excluded: RET mutation
Receipt of prior targeted therapy, including but not limited to those targeting...RET fusions or mutations
Excluded: BRAF V600E
Receipt of prior targeted therapy, including but not limited to those targeting...BRAF V600E mutation
Excluded: MET exon 14 skipping mutation
Receipt of prior targeted therapy, including but not limited to those targeting...MET exon 14 skipping mutation
Excluded: KRAS G12C
Receipt of prior targeted therapy, including but not limited to those targeting...KRAS G12C mutation
Excluded: EGFR targeted therapy
Prior treatment with...any other agent that targets Epidermal Growth Factor Receptor (EGFR) or HER3, including pan-HER inhibitors
Excluded: ERBB3 targeted therapy
Prior treatment with...any other agent that targets Epidermal Growth Factor Receptor (EGFR) or HER3, including pan-HER inhibitors
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: HMBD-001 (HMBD-001)
Prior treatment with HMBD-001
Cannot have received: docetaxel (docetaxel)
Exception: Prior treatment with docetaxel is allowed for Arm C
Prior treatment with docetaxel
Cannot have received: cetuximab (cetuximab)
Prior treatment with cetuximab
Cannot have received: EGFR-targeted therapy
any other agent that targets Epidermal Growth Factor Receptor (EGFR) or HER3, including pan-HER inhibitors
Cannot have received: HER3-targeted therapy
any other agent that targets Epidermal Growth Factor Receptor (EGFR) or HER3, including pan-HER inhibitors
Cannot have received: targeted therapy
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
Lab requirements
Blood counts
Kidney function
Liver function
Cardiac function
Evidence of abnormal cardiac function [excluded]
Have adequate organ function; Evidence of abnormal cardiac function [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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