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OncoMatch/Clinical Trials/NCT05910827

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

Is NCT05910827 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies multiple treatments including HMBD-001 and Docetaxel for advanced or metastatic squamous non-small cell lung cancer.

Phase 1/2RecruitingHummingbird BioscienceNCT05910827Data as of Sep 2026Location: International · 5 countries

Treatment: HMBD-001 · Docetaxel · CetuximabThis 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

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Extracted eligibility criteria

Treatments studied

Targeted therapy

Cetuximab

Chemotherapy

Docetaxel

Other

HMBD-001

Cancer type

Non-Small Cell Lung Carcinoma

Head and Neck Squamous Cell Carcinoma

Esophageal Carcinoma

Biomarker criteria

Excluded: EGFR activating mutation

prior targeted therapy, including but not limited to those targeting EGFR activating mutations

Excluded: ALK fusion

prior targeted therapy, including but not limited to those targeting ... ALK fusions

Excluded: ROS1 rearrangement

prior targeted therapy, including but not limited to those targeting ... ROS rearrangements

Excluded: RET fusion

prior targeted therapy, including but not limited to those targeting ... RET fusions or mutations

Excluded: RET mutation

prior targeted therapy, including but not limited to those targeting ... RET fusions or mutations

Excluded: BRAF v600e

prior targeted therapy, including but not limited to those targeting ... BRAF V600E mutation

Excluded: MET exon 14 skipping mutation

prior targeted therapy, including but not limited to those targeting ... MET exon 14 skipping mutation

Excluded: KRAS g12c

prior targeted therapy, including but not limited to those targeting ... KRAS G12C mutation

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: cetuximab (cetuximab)

Prior treatment with cetuximab

Cannot have received: docetaxel (docetaxel)

Exception: Prior treatment with docetaxel is allowed for Arm C

Prior treatment with docetaxel is allowed for Arm C

Cannot have received: EGFR-targeted therapy

Prior treatment with any other agent that targets Epidermal Growth Factor Receptor (EGFR)

Cannot have received: HER3-targeted therapy

Prior treatment with any other agent that targets HER3

Cannot have received: pan-HER inhibitor

Prior treatment with pan-HER inhibitors

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.

Frequently asked questions

Is NCT05910827 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior HMBD-001, cetuximab, docetaxel disqualifies patients from enrollment.

Are patients with EGFR alterations eligible?

No. EGFR activating mutation is an exclusion criterion.

Are patients with ALK alterations eligible?

No. ALK fusion is an exclusion criterion.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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