Study of AMG 193 alone and in combination with docetaxel in advanced MTAP-null solid tumour patients

• Research type

  Research Study

• Full title

  A phase 1/1b/2 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AMG 193 alone and in combination with docetaxel in subjects with advanced MTAP null solid tumors

• IRAS ID

  1004490

• Contact name

  Matthew Rodaway

• Contact email

  UKRegClinical@amgen.com

• Sponsor organisation

  Amgen Inc.

• Eudract number

  2021-004764-10

• Clinicaltrials.gov Identifier

  NCT05094336

• Research summary

  This study is being done to assess whether AMG 193 alone and in combination with docetaxel is safe and effective treatment option for people with advanced solid tumours with methylthioadenosine phosphorylase (MTAP) loss.

  We will enrol to this study people with an advanced cancer that has a DNA change, either loss of MTAP or loss of cyclin dependent kinase inhibitor 2A (CDKN2A), that may limit the way in which the enzyme, protein arginine methyltransferase 5 (PRMT5), works in their cancer. Protein arginine methyltransferase 5 is important for cancer cell existence and AMG 193 is a PRTM5 inhibitor that may work with the DNA change in cancer cells to further inhibit PRMT5 to kill the cancer. AMG 193 stops PRMT5 activity in cancer cells with MTAP loss and specifically kill them.

  The study will consist of 2 parts. The purpose of Part 1 and Part 2 is to look at what doses of AMG 193 alone or in combination with docetaxel are safe to take for people with metastatic or locally advanced solid tumours lacking MTAP. The study also evaluates the anti-cancer activity of AMG 193 alone or in combination with docetaxel in people with solid tumours lacking MTAP.
  Eligibility criteria will be evaluated for each candidate during screening process. Only candidates that meet the conditions the study is looking for will be enrolled.

  In Parts 1a, 1b, and 2a, eligibility of participants will be assessed based on the CDKN2A status and MTAP status on all cohorts.
  Each enrolled person will be in this study for up to 2 years. This includes screening period lasting up to 4 weeks, a treatment period lasting approximately 6 months, depending on treatment effect or disease status, and a follow up period up to 2 years from the first dose of AMG 193.

• REC name

  London - Central Research Ethics Committee

• REC reference

  22/LO/0060

• Date of REC Opinion

  31 Mar 2022

• REC opinion

  Further Information Favourable Opinion