RecruitingPhase 1NCT06959706

Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Participants With Advanced Solid Tumors

Phase 1, First-in-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Patients With Advanced Solid Tumors


Sponsor

Tagworks Pharmaceuticals BV

Enrollment

50 participants

Start Date

May 7, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objectives of this study are to evaluate the safety and tolerability of TGW101 and determine the recommended dosing regimen(s) for further study. The secondary objectives are to assess pharmacokinetics and preliminary antitumor activity.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1 study is testing a new cancer drug called TGW101 in people with advanced solid tumors, including cancers of the breast, prostate, cervix, endometrium, stomach, lung, ovaries, and head and neck. The goal is to find the safest dose of TGW101 and to get early signals about whether it can shrink tumors. Adults aged 18 and older whose cancer has continued to grow despite standard treatments may be eligible if they have at least one measurable lesion and are in reasonably good overall health. Participation involves receiving TGW101 through infusion, regular clinic visits, blood tests, and imaging scans to monitor response and safety. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTGW101

TGW101 is a combination product comprising a chemically cleavable diabody drug conjugate (TGW101-ADC) and a corresponding small molecule chemical trigger (TRG001) administered separately.


Locations(7)

Honor Health

Scottsdale, Arizona, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

NEXT Dallas

Irving, Texas, United States

NEXT San Antonio

San Antonio, Texas, United States

NEXT Virginia

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT06959706


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