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

Description

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.

Conditions

Solid Tumors, Advanced Solid Tumors, Metastatic Solid Tumors

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Study Overview

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Study Details

Study overview

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.

A Phase 1, Open-Label, Multicenter Study of INCA33890 in Participants With Advanced or Metastatic Solid Tumors

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

Condition
Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Los Angeles

The Angeles Clinic and Research Institute, Los Angeles, California, United States, 90025

Boston

Dana Farber Cancer Institute, Boston, Massachusetts, United States, 02215

Grand Rapids

Cancer and Hematology Centers of Western Michigan-Start Midwest, Grand Rapids, Michigan, United States, 49546

Hackensack

Hackensack University Medical Center, Hackensack, New Jersey, United States, 07601

Providence

Lifespan Cancer Research Institute, Providence, Rhode Island, United States, 02903

Houston

University of Texas Md Anderson Cancer Center, Houston, Texas, United States, 77030

San Antonio

South Texas Accelerated Research Therapeutics, San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * ≥18 years old
  • * Histologically or cytologically confirmed advanced or metastatic malignancies as defined in the protocol.
  • * Participants must have experienced disease progression after treatment with available therapies, including anti-PD-(L)1 or anti-CTLA4 therapy if applicable, that are known to confer clinical benefit, or who are intolerant to, or ineligible for standard treatment. Prior anti-PD-(L)1 therapy should not have been discontinued because of intolerance.
  • * ECOG performance status score of 0 or 1.
  • * Willingness to undergo pre- and on-treatment tumor biopsy (core or excisional). Biopsies are mandatory for Part 1b cohorts only.
  • * Presence of measurable disease according to RECIST v1.1
  • * 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 active autoimmune disease requiring systemic immunosuppression with corticosteroids Brain or CNS metastases untreated or that have progressed
  • * History of organ transplant, including allogeneic stem cell transplantation.
  • * Received more than 4 prior anticancer regimen(s) for advanced or metastatic disease.
  • * History of clinically significant or uncontrolled cardiac disease
  • * Active HBV (or at risk of activation), active HCV, or HIV positive
  • * Is on chronic systemic steroids (\> 10 mg/day of prednisone or equivalent).
  • * Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment
  • * Participants that have been initiated on or had modifications in anticoagulation therapies within the last 3 months prior to first dose of treatment.
  • * Significant concurrent, uncontrolled medical condition, eg:
  • * Cardiovascular: Participants with known vasculitis, aneurisms, and other vascular malformations of clinical significance
  • * Participants with adequate laboratory values within the protocol defined ranges.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Incyte Corporation,

Study Record Dates

2026-12-24