A Phase 1 Study of INCA00186 in advanced solid tumours

• Research type

  Research Study

• Full title

  A Phase 1, Open-Label, Multicenter Study of INCA00186 as Monotherapy or in Combination With Immunotherapy in Participants With Advanced Solid Tumors

• IRAS ID

  1005608

• Contact name

  Carol Penning

• Contact email

  cpenning@incyte.com

• Sponsor organisation

  Incyte Corporation

• Eudract number

  2021-001263-24

• Clinicaltrials.gov Identifier

  NCT04989387

• Research summary

  Summary of Research
  This is a multicentre, open-label, dose escalation, and dose expansion First In Human, Phase 1 clinical study to investigate the safety, tolerability, pharmacokinetic profile, pharmacodynamics, and preliminary clinical efficacy of INCA00186 when given as monotherapy and in combination with retifanlimab and/or INCB106385 in participants with selected advanced solid tumours.

  Phase 1a will consist of a dose escalation for each treatment group using a hybrid design. This will allow evaluation of the safety and tolerability of the following study treatments in participants with advanced solid tumours:
  • INCA00186 as monotherapy (TGA)
  • INCA00186 in combination with retifanlimab (TGB1)
  • INCA00186 in combination with INCB106385 (TGB2)
  • INCA00186 in combination with retifanlimab and INCB106385 (TGC)

  In each treatment group, one participant will first be treated in any given dose level cohort, with a period of > 24 hours before dosing start of subsequent participants at that dose level.

  Following initial dose escalation cohorts in each of the treatment groups, the sponsor will restrict enrolment into the subsequent dose escalation cohorts to participants with CD8 T-cell–positive advanced squamous cell carcinoma of the head and neck or specified GI malignancies and pre- and on-treatment biopsies will become mandatory. This may occur before opening enrolment into the second dose level or anytime thereafter and will be based on emerging pharmacokinetic data.

  Phase 1b is a dose expansion to better characterize the safety, tolerability, pharmacokinetics, pharmacodynamic effects, and preliminary tumour activity of INCA00186 as monotherapy or in combination with retifanlimab and/or INCB106385 in a total of approximately 120 evaluable participants. Participants in Phase 1b will be limited to those with selected CD8 T-cell–positive advanced or metastatic squamous cell carcinoma of the head and neck or specified GI malignancies.

  Summary of Results
  A final summary of results was submitted to EudraCT
  

• REC name

  HSC REC A

• REC reference

  22/NI/0159

• Date of REC Opinion

  22 Dec 2022

• REC opinion

  Further Information Favourable Opinion