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

Trial number:
NCT05910827
Trial phase:
1, 2
Study type:
Chemotherapy, Targeted therapy
Overall status:
Recruiting

Study start date

February, 2024

Scientific title

A Phase Ib/II Study to Evaluate HMBD-001 in Combination With Cetuximab, With or Without Docetaxel in Participants With Advanced Squamous Cell Carcinomas

Summary

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

* 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 * Arm C only: Advanced or metastatic sqNSCLC, HNSCC, ESCC, CSCC, cervical SCC, NPC and other SCCs 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 biopsy sample * Have adequate organ function * Females must be non-pregnant and non-lactating, willing to use a highly effective method of contraception from 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

Study design

Primary purpose: TREATMENT, Allocation: NON_RANDOMIZED, Intervention model: PARALLEL, Masking: NONE,

Conditions

Advanced 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

Other study ID numbers

HMBD-001-103

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