RGT-61159 in Adenoid Cystic Carcinoma or Colorectal Carcinoma

• Research type

  Research Study

• Full title

  A Phase 1a/1b, First-in-human, Multicenter Study to Assess the Efficacy and Safety of RGT-61159 for Treatment of Patients with Relapsed/Refractory Adenoid Cystic Carcinoma (ACC) or Colorectal Carcinoma (CRC)

• IRAS ID

  1009910

• Contact name

  Michele Devries

• Contact email

  mdevries@consultingjw.com

• Sponsor organisation

  Rgenta Therapeutics Inc.

• Clinicaltrials.gov Identifier

  NCT06462183

• Research summary

  This Phase 1a/1b study assesses an investigational medicinal product called RGT-61159 in patients with advanced adenoid cystic cancer (ACC) or colorectal cancer (CRC), for which standard therapy is no longer effective or does not exist.

  RGT-61159 blocks the expression of MYB protein, which is frequently over expressed in these cancer types and promotes the growth of cancer cells. Therefore RGT-61159 is thought to slow down or stop the growth of these cancers.

  The study will be conducted in 2 parts:

  • Part 1 (Dose Escalation) – will include about 30 participants.
  A group of 1-6 participants will receive the lowest dose of RGT-61159, and if the study drug does not cause any severe side effects, then a second group of 1-6 participants will receive a higher dose. Additional groups of 1-6 participants will receive higher doses until some participants have severe side effects or until the maximum dose is given.

  • Part 2 (Dose Optimisation and expansion) – will include about 75 participants.
  Once a maximum tolerated dose is found in Part 1, a larger number of participants will be enrolled and receive varying doses of RGT-61159 in order to find the optimal dose which has maximum clinical benefit but optimal tolerability.

  Patients will continue on daily treatment in 21-day treatment cycles until patient discontinuation, withdrawal, or study termination, and long-term follow-up will continue up to 5 years.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  24/YH/0193

• Date of REC Opinion

  20 Sep 2024

• REC opinion

  Further Information Unfavourable Opinion