Summary
TTX-080-001 is a Phase 1, open label, dose escalation and dose expansion clinical study to determine the safety, tolerability, and recommended Phase 2 dose of TTX-080 monotherapy (HLA-G inhibitor) and in combination with either pembrolizumab (PD-1 inhibitor), cetuximab (EGFR inhibitor) or FOLFIRI plus cetuximab (EGFR inhibitor) in patients with advanced refractory / resistant solid malignancies including metastatic colorectal cancer (mCRC) patients.
Official Title
A Phase 1a/1b Dose Escalation/Expansion Study of TTX-080, an HLA-G Antagonist, As Monotherapy and in Combination with Pembrolizumab, Cetuximab or FOLFIRI Plus Cetuximab in Patients with Advanced Solid Refractory/Resistant Malignancies
Details
TTX-080 is a fully human mAb designed to block the interaction of HLA-G with its known ligands, ILT2 and ILT4 molecules. The Phase 1a was an open label, multicenter, dose escalation clinical trial to determine the safety, tolerability, MTD or OBD, and the RP2D of TTX-080 when administered as a single agent. The Phase 1b is a dose expansion of TTX-080 monotherapy and in combination with either pembrolizumab or cetuximab in adult subjects with advanced refractory/resistant solid malignancies, including Head and Neck squamous cell carcinoma (HNSCC), Non-Small Cell Lung Cancer (NSCLC), Colorectal cancer (CRC), triple negative breast cancer (TNBC), renal cell carcinoma (RCC), and acral melanoma. Additionally, the Phase 1b includes randomized arms with TTX-080 in combination with FOLFIRI plus cetuximab compared to FOLFIRI plus cetuximab in metastatic Colorectal cancer. The study will seek to evaluate the pharmacokinetics and immunogenicity of TTX-080, and characterize the anti-tumor activity of TTX-080 as a monotherapy and in combination with pembrolizumab, cetuximab or FOLFIRI plus cetuximab.
Keywords
Cancer, HLA-G, TTX-080, Advanced Solid Tumor, Ovarian Cancer, Endometrial Cancer, Cervical Cancer, Kidney Cancer, Head and Neck Squamous Cell Carcinoma, Squamous Cell Lung Cancer, Prostate Cancer, Colorectal Cancer, Gastric Cancer, Breast Cancer, Bladder Cancer, Lung Adenocarcinoma, Melanoma, Metastatic Solid Tumor, Renal cell carcinoma, Acral melanoma, Triple Negative Breast Cancer, Pembrolizumab, Cetuximab, Antineoplastic Agents, Immunological, Antineoplastic Agents, Head and Neck Cancer, Lung Cancer, FOLFIRI, FOLFIRI plus cetuximab
