ST101-101 Phase 1-2 Study in Advanced Cancer

  • Research type

    Research Study

  • Full title

    A phase 1-2 dose-escalation and expansion study of ST101 in patients with advanced unresectable and metastatic solid tumors

  • IRAS ID

    276534

  • Contact name

    Gina Capiaux

  • Contact email

    gcapiaux@sapiencetherapeutics.com

  • Sponsor organisation

    Sapience Therapeutics, Inc.

  • Eudract number

    2019-004213-13

  • Clinicaltrials.gov Identifier

    NCT04478279

  • Duration of Study in the UK

    3 years, 0 months, 29 days

  • Research summary

    This study is a multicenter study conducted in oncology centers at hospitals in the United Kingdom and the United States. The Sponsor is trying to find the safest and most effective dose of the medicine ST101 for people with tumors that are spreading and cannot be removed by surgery. ST101 is an experimental cancer medication that has been shown to inhibit tumor growth in animal studies. Therefore, the Sponsor will be evaluating the optimal dose of the medication and evaluating the medicine's anti-tumor activity in 4 different cancers. This study will explore the safety and efficacy of ST101 in patients with advanced cancer. A typical patient will receive 6 months of treatment (until progression or study withdrawal) followed by 4 months of follow-up.

  • REC name

    North East - Newcastle & North Tyneside 1 Research Ethics Committee

  • REC reference

    20/NE/0159

  • Date of REC Opinion

    13 Jul 2020

  • REC opinion

    Further Information Favourable Opinion