217228 PVRIG First Time in Humans

• Research type

  Research Study

• Full title

  A Phase 1 First-Time-in-Human, Open-Label Study of GSK4381562 Administered as Monotherapy and in Combination with Anticancer Agents in Participants with Selected Advanced Solid Tumors

• IRAS ID

  1006639

• Contact name

  Jayprit Serai

• Contact email

  jayprit.x.serai@gsk.com

• Sponsor organisation

  GlaxoSmithKline UK LTD

• Eudract number

  2021-004968-95

• Clinicaltrials.gov Identifier

  NCT05277051

• Research summary

  This study is being carried out to determine if GSK4381562 alone and combined with investigational agents GSK4428859A and Dostarlimab are effective in treating a number of cancers. GSK4381562, GSK4428859A and Dostarlimab are types of antibodies being developed by GSK to help the immune system recognise and fight cancer cells. Dostarlimab is approved in the UK for treatment of endometrial cancer.

  The purpose of this study is to determine the safety, tolerability and recommended dose of GSK4381562 and then assess the effectiveness and safety of three different combinations of treatment. The participant and study doctors will know which treatment they are receiving. The drugs will be given as infusions into the blood every 3 weeks.

  The participants will be allocated to one of the following treatment groups:

  1. Arm A - GSK4381562 Monotherapy (Dose escalation dose to be determined)
  2. Arm B - GSK4381562 Doublet therapy (Recommended dose) + Dostarlimab 500mg
  3. Arm C - GSK4381562 Triplet therapy (Recommended dose) + GSK4428859A 400mg + Dostarlimab 500mg

  The initial combination strategy for the study is to combine with other established and experimental immunotherapies directed for the treatment of cancer.

  A Participant’s time on study will include screening (28 days) and treatment period. Participants may continue study treatment until disease progression, unacceptable side-effects, or death. Tests will include, but not limited to, medical history review, blood tests, imaging (CT/MRI) scans, tumour biopsies, stool samples and vital signs.

  Once criteria for stopping treatment is reached the participants will enter a safety follow-up period that will last up to 90 days after the last dose.

  This study will include up to 162 participants globally, 10 in the UK.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  23/NE/0037

• Date of REC Opinion

  1 Jun 2023

• REC opinion

  Further Information Favourable Opinion