Reviewing the Safety of BCA101 for Patients With Advanced Solid Tumors

Recruiting · Phase 1 · Head and Neck Squamous Cell Carcinoma and related conditions · 11 states

Check if I qualify View on ClinicalTrials.gov

About this trial

This trial looks at how safe and well-tolerated a new medicine, BCA101, is for patients with advanced solid tumors caused by EGFR. BCA101 is special because it targets two things at once. The study has different parts. One part tests BCA101 alone, while another part tests it together with another medicine called pembrolizumab. Participants have tumors that haven't responded to standard treatments or where those treatments aren't available.

This is a Phase 1 study, which means researchers are looking at how well the treatment works and how safe it is. The trial plans to include around 292 participants and is FDA-regulated.

Who can join

Adults aged 18 and older can join this study. It is open to both men and women. Participants must have measurable cancer that can be biopsied. They should have a good performance status and have specific types of tumors like squamous cell carcinoma. The trial team will confirm who is eligible.

Conditions

Head and Neck Squamous Cell Carcinoma, Squamous Cell Carcinoma of Anal Canal, Colorectal Cancer, Squamous Cell Carcinoma of the Lung, EGFR Amplification, Epithelial Ovarian Cancer, Pancreas Cancer, Cutaneous Squamous Cell Carcinoma, Head and Neck Neoplasms, Carcinoma, Squamous Cell, Squamous Cell Carcinoma of Head and Neck

Age group

Adult, Older adult

Sex

All sexes

The study team makes the final call on eligibility.

What happens in the study

Participants will be divided into two groups. One group will receive BCA101 by IV infusion once a week. The other group will receive BCA101 along with pembrolizumab every three weeks. Everyone will be monitored for safety and how well the treatments are tolerated.