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Recruiting Phase 1 NCT05836324

A Study to Evaluate the Safety of INCA33890 in Participants With Advanced or Metastatic Solid Tumors

Trial Parameters

Condition Solid Tumors
Sponsor Incyte Corporation
Study Type INTERVENTIONAL
Phase Phase 1
Enrollment 408
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-07-24
Completion 2027-01-13
Interventions
INCA33890bevacizumabFOLFIRI

Brief Summary

To evaluate the safety, tolerability, and DLTs and determine the MTD and/or RDE(s) of INCA33890 in participants with select advanced or metastatic solid tumors.

Eligibility Criteria

Inclusion Criteria: * ≥18 years old * Histologically or cytologically confirmed advanced or metastatic malignancies as defined in the protocol. * Part 1: Participants must have experienced disease progression after treatment with, be intolerant to, or be ineligible for, or refused available therapies, including anti-PD-(L)1 or anti-CTLA4 therapy if applicable, that are known to confer clinical benefit. Part 2: depending on cohort, participants may have received or not prior treatment for the malignancy under study. * ECOG performance status score of 0 or 1. * Willingness to undergo pre- and on-treatment tumor biopsy (core or excisional). Biopsies are mandatory depending on the cohorts. * Presence of measurable disease according to RECIST v1.1. Exclusion Criteria: * Any known additional malignancy that is progressing or requires active treatment, or history of other malignancy within 2 years. * Not recovered to ≤ Grade 1 or baseline from residual toxicities of prior therapy. * Has activ

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