Dose escalation of tolinapant (ASTX660) in combination with standard radical chemoradiotherapy in cervical cancer : a study protocol for a phase 1b TiTE-CRM clinical trial (CRAIN) in UK secondary care centres

Dose Escalation of Tolinapant in Combination with Chemoradiotherapy for Cervical Cancer

Practical Solutions and Value

Cervical cancer is a significant health concern, and the standard treatment has limitations. Tolinapant, an IAP antagonist, has shown promise in preclinical studies when combined with cisplatin and radiotherapy.

The CRAIN trial aims to assess the safety and effectiveness of tolinapant when administered with concurrent chemoradiotherapy. The study will involve up to 42 newly diagnosed cervix cancer patients from six UK secondary care sites.

Treatment will consist of standard chemoradiotherapy with weekly cisplatin, along with tolinapant administered in fixed dose capsules on alternate weeks during chemoradiation. The trial will assess different dose levels for tolinapant and will be guided by emerging safety data and decisions by the Safety Review Committee.

If successful, this trial could lead to future phase II trials and potentially provide a new treatment option for cervical cancer patients, ultimately improving outcomes.

Value of Clinical Trials

Clinical trials play a crucial role in developing safe and effective treatments. Our AI-driven platform, DocSym, consolidates clinical protocols and research into a single, easily accessible knowledge base for clinicians, helping to extend the benefits of clinical trials into everyday medical practice.

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In today’s healthcare environment, streamlining operations is essential. Our mobile apps support scheduling, monitoring treatments, and telemedicine, making it easier to manage patient care and expand services digitally. By using AI, clinics can enhance their workflows and improve patient outcomes, reducing paper routines.

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