RecruitingPhase 1NCT05753722

A First-in-human Study of PRTH-101 Monotherapy +/- Pembrolizumab in Subjects With Advanced Malignancies

An Open-Label Phase 1 Dose-Escalation and Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of PRTH-101 Alone or in Combination With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors


Sponsor

Incendia Therapeutics

Enrollment

270 participants

Start Date

Mar 3, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this Open-Label Study is to evaluate the safety and tolerability of PRTH-101 alone or in combination with pembrolizumab in adults with advance or metastatic solid tumors.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This first-in-human study is testing a new cancer drug called PRTH-101, alone or combined with pembrolizumab (a well-known immunotherapy), in people with advanced cancers that have stopped responding to other treatments. **You may be eligible if...** - You are 18 or older - You have advanced or metastatic cancer that cannot be removed surgically - Your cancer has measurable disease on imaging - You have already tried available treatments and your cancer is still progressing - Your general health is stable enough to participate **You may NOT be eligible if...** - You have hepatocellular carcinoma (liver cancer), sarcoma, or glioma - Your cancer is not measurable on imaging - Your cancer has not previously been treated - You have significant organ dysfunction or other health conditions that would make participation unsafe Talk to your doctor to see if this trial is right for you.

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

BIOLOGICALPRTH-101

PRTH-101 is a humanized immunoglobulin gamma-1 (IgG1) monoclonal antibody

BIOLOGICALPembrolizumab

PRTH-101 in combination with Pembrolizumab


Locations(11)

Honor Health Research Institute

Scottsdale, Arizona, United States

Yale Cancer Center

New Haven, Connecticut, United States

Mass General Cancer Center

Boston, Massachusetts, United States

Providence Cancer Institute Franz Clinic

Portland, Oregon, United States

University of Pittsburgh Medical Center Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

NEXT Houston

Houston, Texas, United States

Next Oncology

Irving, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

Next Oncology

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05753722


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