Phase 1 Study of TTX-080, an HLA-G Blocker, Alone and With Pembrolizumab, Cetuximab, or FOLFIRI Plus Cetuximab in Adults With Advanced Resistant Cancers

What this Trial Is About

Researchers are evaluating the safety, tolerability, and recommended Phase 2 dose of TTX-080, an HLA-G inhibitor, alone and in combination with pembrolizumab, cetuximab, or FOLFIRI plus cetuximab. This Phase 1, open-label trial includes patients with advanced refractory or resistant solid cancers, such as metastatic colorectal cancer and other types like head and neck squamous cell carcinoma, non-small cell lung cancer, triple-negative breast cancer, renal cell carcinoma, and acral melanoma. The study consists of dose escalation and dose expansion phases. Participants may receive TTX-080 as monotherapy or combined with pembrolizumab a PD-1 inhibitor, cetuximab an EGFR inhibitor, or FOLFIRI plus cetuximab chemotherapy regimens. Different arms focus on specific cancer types and treatment histories, including randomized arms comparing TTX-080 with FOLFIRI plus cetuximab versus FOLFIRI plus cetuximab alone for metastatic colorectal cancer patients. Participants will undergo assessments over up to 48 months, including tumor response evaluations using RECIST 1.1 criteria, pharmacokinetic and immunogenicity testing, and monitoring for adverse events and tolerability. Researchers will track various outcomes such as duration of response, progression-free survival, overall survival, and drug concentration levels to understand TTX-080s activity and safety profile.

TTX-080 HLA-G Antagonist in Subjects With Advanced Cancers