Study of an Anti-HER3 Antibody, HMBD-001, With Docetaxel +/- Cetuximab in Advanced Squamous Non-small Cell Lung 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

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

Ability to understand and be willing to sign an informed consent form

Males and females aged over 18 yearsEastern Cooperative Oncology Group (ECOG) status of 0 to 1 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 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: Randomized, Intervention model: Parallel Assignment, Masking: None (Open Label),

Conditions

Advanced or Metastatic Squamous Non-Small Cell Lung Cancer

Other study ID numbers

HMBD-001-103

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