A PHASE 1 STUDY OF TJ033721 IN SUBJECTS WITH ADVANCED OR METASTATIC SOLID TUMORS

Primary Objective

This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD PK, and PD of TJ033721 in subjects with advanced or metastatic solid tumors.

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Description

This study plans to learn more about the safety of a study drug called TJ033721 (givastomig). The study is designed in 2 Parts: Part 1 and Part 2. This consent from describes the details of Part 1, which will test different dose levels to find out what effects, both good and/or bad, the study treatment has on you and your solid tumor. The study drug is investigational and has been tested in animals, but not yet in people. “Investigational” means that the study drug has not been approved by the U.S. Food and Drug Administration (FDA). This study tests up to 9 different doses of the study drug to see which dose is safe in people. The dose you receive will depend on when you start the study. The study drug’s effects will be measured by testing samples of your blood, scanning your tumor area, and in some cases taking a biopsy of your tumor. The study staff will also watch for physical changes after you are given the study drug. You are being asked to be in Part 1 of this research study because you have been diagnosed with advanced solid tumor cancer and because of your cancer’s response to treatments you have already received.

Details
Age
Adult
Eligibility
Detailed eligibility criteria is available on clinicaltrials.gov. These requirements will be discussed with your doctor and/or study representative. Click the NCT number link below to learn more about this study on ClinicalTrials.gov
Locations

Outpatient CTRC
University of Colorado Hospital

Principal Investigator
Photograph of Sunnie Kim

Sunnie Kim

Study ID

Protocol Number: 21-3254

More information available at ClinicalTrials.gov: NCT04900818

Categories

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