Phase 1, Open-Label Study of INCA33890 in Participants With Advanced or Metastatic Solid Tumors
Research type
Research Study
Full title
A Phase 1, Open-Label, Multicenter Study of INCA33890 in Participants With Advanced or Metastatic Solid Tumors
IRAS ID
1007631
Contact name
Michael McGraw
Contact email
Sponsor organisation
Incyte Corporation
Research summary
This is a Phase 1, first-in-human, multicenter, open-label, dose-escalation, and dose-expansion clinical study to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy of INCA33890 in participants with select advanced or metastatic solid tumours. The study will be conducted in 2 separate parts.
In Part 1a of the Study, we will look at how safe the Study Drug is and how the patient and their disease react to it. We also want to find out what the highest dose of the Study Drug is that patients with selected advanced or metastatic malignancies can take with the fewest side effects. This is called “Dose Escalation.”
Part 1b will begin after the safest dose(s) of the Study Drug are chosen from Part 1a. In Part 1b, we will further look at how safe the Study Drug is at the chosen doses, and better understand any effects that it may have on the patients cancer, if any.
We expect about 165 participants to be enrolled in this Study (35 participants in Part 1a and 130 participants in Part 1b).
Patients are expected to participate in the study for up to 28 days for screening, continuous treatment up to 2 years in consecutive 28-day cycles as long as participants are receiving benefit and have not met any criteria for treatment discontinuation, followed by 30 (+ 7) and 90 (+ 14) days for safety follow-ups.
REC name
London - City & East Research Ethics Committee
REC reference
23/LO/0594
Date of REC Opinion
26 Sep 2023
REC opinion
Further Information Favourable Opinion