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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

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Trial Profile

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

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 18 Jun 2025

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At a glance

  • Drugs Cetuximab (Primary) ; Pembrolizumab (Primary) ; TTX 080 (Primary) ; Fluorouracil; Folinic acid; Irinotecan; Oxaliplatin
  • Indications Advanced breast cancer; Carcinoma; Colorectal cancer; Head and neck cancer; Non-small cell lung cancer; Solid tumours; Squamous cell cancer; Triple negative breast cancer
  • Focus First in man; Therapeutic Use
  • Sponsors Tizona Therapeutics

Most Recent Events

  • 01 Nov 2024 Planned primary completion date changed from 30 June 2024 to 1 Jun 2027.
  • 01 Nov 2024 Status changed from active, no longer recruiting to recruiting.
  • 01 Nov 2024 Number of treatment arms are increased from 9 to 11, by the addition of 2 new treatment arms evaluating TTX-080 plus cetuximab and FOLFIRI or cetuximab and FOLFIRI alone.

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