A Study of CA-170 in participants with Advanced Tumours and Lymphomas

  • Research type

    Research Study

  • Full title

    A Phase 1, Open-Label, Dose Escalation and Dose Expansion Trial Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Effects of Orally Administered CA-170 in Patients with Advanced Tumors and Lymphomas

  • IRAS ID

    214065

  • Contact name

    Simon Pacey

  • Contact email

    simonpacey@medschl.cam.ac.uk

  • Sponsor organisation

    Curis, Inc.

  • Eudract number

    2016-002203-26

  • Clinicaltrials.gov Identifier

    NCT02812875

  • Duration of Study in the UK

    2 years, 8 months, 28 days

  • Research summary

    The study drug, CA-170, is an experimental medicine which means it has not been approved by the drug approval agency. This is the first study in which the study drug is being given to humans. Potential participants will be invited to take part who have advanced solid tumours or lymphomas who cannot tolerate, are not expected to benefit from, or are otherwise ineligible for other standard treatment for their condition (including approved drugs immune checkpoint inhibitors, when applicable). This study is designed to determine the safety and tolerability of the study drug, including the maximum tolerated dose in patients with solid tumours or lymphomas. In addition the study includes attempts to better understand of the effects of CA170 in tumours. This study will have several treatment cycles, each lasting 21 days. Participants can continue to receive study drug for as long as they are deriving clinical benefit, until either disease progression or intolerable toxicity occurs. About 300 participants will be in the study across Europe.

  • REC name

    London - Chelsea Research Ethics Committee

  • REC reference

    17/LO/0145

  • Date of REC Opinion

    13 Apr 2017

  • REC opinion

    Further Information Favourable Opinion