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

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

Study start date

February, 2024

Scientific title

A Phase 1b Study to Evaluate HMBD-001 in Combination With Docetaxel With or Without Cetuximab in Participants With Advanced Squamous Non-Small Cell Lung Cancers, and HMBD-001 in Combination With Cetuximab in Participants With Advanced Squamous Cell Cancers

Summary

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

* 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 or cervical SCC 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

Other study ID numbers

HMBD-001-103

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