Clinical Trial

A Phase 1a/1b Dose Escalation/Expansion Study of TTX-080, an HLA-G Antagonist, as Monotherapy and in Combination with Pembrolizumab or Cetuximab in Patients with Advanced Solid Refractory/Resistant Malignancies (TTX-080-001)

MOA: TX-080 is an anti-HLA-G antibody that binds specifically to HLA-G and blocks engagement with ILT2 and ILT4 and reverses HLA-G-mediated immunosuppression.

Key Eligibility Criteria:

• Histologically or cytologically confirmed mCRC that is incurable
• Tumors must be MSS, WT for RAS, WT for BRAF, and HER2- negative
• Patients must be either:
  • 1L Setting: No prior systemic therapy for metastatic colorectal cancer.
  • 2L Setting: One prior regimen with 5-FU + oxaliplatin ± bevacizumab. Subjects may have received prior irinotecan allowed if used with 5-FU + oxaliplatin. Capecitabine counts as a 5-FU-based regimen.
• Subjects that received prior anti-EGFR therapy are excluded
• Must be eligible to receive cetuximab