Taiho TAS0612-101

  • Research type

    Research Study

  • Full title

    A Phase 1 Study of TAS0612 in Patients with Locally Advanced or Metastatic Solid Tumors.

  • IRAS ID

    308883

  • Contact name

    Jill Kremer

  • Contact email

    jkremer@taihooncology.com

  • Sponsor organisation

    Taiho Oncology, Inc.

  • Eudract number

    2020-002304-39

  • Clinicaltrials.gov Identifier

    NCT04586270

  • Clinicaltrials.gov Identifier

    149137, IND Number

  • Duration of Study in the UK

    2 years, 2 months, 1 days

  • Research summary

    This is a clinical research trial of TAS0612, which is a drug under investigation. This means that TAS0612 has not been approved for use in the UK and/or for use in subjects with locally advanced or metastatic solid tumors, except in a clinical research trial.

    TAS0612 is a research drug that blocks kinases. Kinases are parts of a cell that help it grow, and TAS0612 mostly blocks 3 kinases named RSK, AKT and S6K. Some cancers may grow because RSK, AKT and S6K are not acting normally. TAS0612 may be able to stop cancer growth by blocking RSK, AKT and S6K.

    The main purpose of the trial is to find the maximum tolerated dose (MTD), the recommended phase 2 dose (RP2D), and to study the efficacy of TAS0612. The MTD is the highest and safest dose to give subjects. The RP2D is the dose that will be used in subjects that is the safest and has the best chance at shrinking cancer tumors. Efficacy is studying if TAS0612 can stop or shrink the tumor.

  • REC name

    North East - Newcastle & North Tyneside 2 Research Ethics Committee

  • REC reference

    22/NE/0049

  • Date of REC Opinion

    28 Apr 2022

  • REC opinion

    Further Information Favourable Opinion