Clinical trial approval has been granted for a Phase II study of TRANSTHERA-B's (ASX: 02617) investigational drug TT-00973 in combination with furmonertinib for a specific type of lung cancer.

The company announced that its product, TT-00973 tablets in combination with furmonertinib for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-sensitive mutations, received approval from China's National Medical Products Administration (NMPA) on July 10, 2026.

Study Design and Objectives

This trial is a multi-center, open-label Phase II study designed to evaluate the safety and efficacy of the TT-00973 and furmonertinib combination in patients with EGFR-mutant locally advanced or metastatic NSCLC.

Mechanism of Action

TT-00973 is a novel, internally developed dual AXL/FLT3 inhibitor. The AXL kinase is a key factor in cancer survival, metastasis, and drug resistance, with its abnormal activation linked to poor prognosis in various cancers.

TT-00973 effectively interferes with AXL activation in tumor cells and has demonstrated significant anti-tumor activity in preclinical models with AXL overexpression.

Clinical Development Progress

As of December 31, 2025, the company had completed a Phase I clinical trial where TT-00973 was well-tolerated, with clinical efficacy observed in some patients with solid tumors.

Strategic Collaboration

In May 2026, the company entered into a clinical collaboration and drug supply agreement with Shanghai Allist Pharmaceutical Technology Co., Ltd. to jointly conduct this Phase II study.

The partners will explore opportunities for further collaboration on a potential Phase III trial for the TT-00973 and furmonertinib combination based on the results of this approved study.