The arms will enrol metastatic colorectal cancer patients who are MSS, WT RAS, WT BRAF, and HER2-negative. Credit: SewCreamStudio/Shutterstock.

Tizona Therapeutics has expanded its ongoing Phase Ib clinical trial of TTX-080, a novel antibody targeting human leukocyte antigen-G (HLA-G), in patients with biomarker-defined metastatic colorectal cancer (mCRC).

With the trial expansion, the company initiated two randomised arms in the trial.

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These arms will assess the efficacy of TTX-080 in combination with cetuximab and FOLFIRI or cetuximab and FOLFIRI in the second-line setting.

The arms will enrol mCRC patients who are microsatellite stable (MSS), wild type (WT) RAS, WT BRAF, and human epidermal growth factor receptor 2 (HER2)-negative.

These patients have priorly received fluorouracil (5-FU) and oxaliplatin in the front-line or adjuvant setting and experienced a relapse within six months.

The primary endpoint is the overall response rate, with secondary endpoints including safety, duration of response, median progression-free survival, and median overall survival.

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In May this year, the company reported data from a open-label, dose-escalation and expansion Phase 1 trial of TTX-080. It assessed the safety, tolerability, recommended Phase II dose, and initial efficacy of TTX-080 both as a single agent and along with cetuximab or pembrolizumab in advanced, refractory or resistant solid tumour patients.

Acording to the findings, TTX-080 demonstrated good tolerability as a monotherapy and in combination with cetuximab in mCRC and metastatic head and neck squamous cell carcinoma (mHNSCC) patients.

Previously in October 2021, Tizona began a Phase Ib expansion study to assess the safety and efficacy of TTX-080 as a single agent and in combination with pembrolizumab or cetuximab for patients with advanced refractory or resistant solid tumour malignancies.

The study includes patients with head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSCLC), colorectal cancer, and triple negative breast cancer.

The study also evaluated the anti-tumour activity of TTX-080, as well as its safety, pharmacokinetics, immunogenicity, and potential biomarkers.