RECRUITING

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

Conditions

Solid Tumors Advanced Solid Tumors Metastatic Solid Tumors INCA33890

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-07-24

Study Completion:2026-12-24

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05836324

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Incyte Corporation Call Center (US)

CONTACT

1.855.463.3463

medinfo@incyte.com

Incyte Corporation Call Center (ex-US)

CONTACT

+800 00027423

eumedinfo@incyte.com

Study Locations (Sites)

The Angeles Clinic and Research Institute

Los Angeles, California, 90025

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Cancer and Hematology Centers of Western Michigan-Start Midwest

Grand Rapids, Michigan, 49546

United States

Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

Lifespan Cancer Research Institute

Providence, Rhode Island, 02903

United States

University of Texas Md Anderson Cancer Center

Houston, Texas, 77030

United States

South Texas Accelerated Research Therapeutics

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: Incyte Corporation

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-24

Study Completion Date2026-12-24

Study Record Updates

Study Start Date2023-07-24

Study Completion Date2026-12-24

Terms related to this study

Keywords Provided by Researchers

Solid Tumors
INCA33890

Additional Relevant MeSH Terms

Solid Tumors
Advanced Solid Tumors
Metastatic Solid Tumors