Phase 2 Trial Tests Tinengotinib With Darolutamide or Enzalutamide in Hormone-Resistant Prostate Cancer

A newly registered phase 2 clinical trial will investigate whether combining tinengotinib (TT-00420) with darolutamide or enzalutamide can improve disease control in men with metastatic castration-resistant prostate cancer (mCRPC).

Tinengotinib is an oral multikinase inhibitor targeting several pathways involved in cancer growth and survival, including FGFR, JAK, VEGFR and Aurora kinases. Unlike darolutamide and enzalutamide, which inhibit androgen receptor signalling, tinengotinib acts on alternative molecular pathways that may contribute to resistance to hormonal treatment.

Preclinical studies have demonstrated activity against prostate cancer cells, including enzalutamide-resistant models and cells displaying neuroendocrine characteristics. Combining tinengotinib with androgen receptor inhibition has also shown encouraging laboratory results.

There is already some preliminary clinical evidence. In an earlier phase 1 study involving 48 patients with advanced solid tumours, one patient with castration-resistant prostate cancer achieved a partial response. A subsequent early-phase study reported an objective response rate of 33.3% among 15 prostate cancer patients, although the small sample limits interpretation.

Clinical trial.