RecruitingPhase 1Phase 2NCT07266428

A Study of OTP-01, a Dual Paratopic PD-1/VEGFR2 Antibody, in Patients With Advanced Solid Tumors

Phase 1/2A Study of OTP-01, a Dual Paratopic PD-1/VEGFR2 Antibody, in Patients With Advanced Solid Tumors


Sponsor

Ottimo Pharma Limited

Enrollment

170 participants

Start Date

Dec 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The main goals of this clinical trial are to find out what the best dose of the study drug, OTP-01, is for patients with solid tumors through understanding how it is tolerated and any side effects that it may cause. The trial will also see if OTP-01 causes tumors to shrink and how the body processes OTP-01 by measuring drug levels in the blood. The main questions this study aims to answer are: * What is the recommended dose of OTP-01 for adults with solid tumors? * Is OTP-01 safe and tolerable? * Does OTP-01 reduce tumor growth? Participants will: * Receive OTP-01 through an infusion into a vein. Doses will be spaced out and never more than once a week. * Have blood tests to evaluate safety and drug levels of OTP-01. These will be done often at first and then less frequently as treatment continues. * Have radiographic scans of their tumor at baseline and during the study at regular intervals. * Have the choice to have an optional tumor biopsy before and after treatment to help researchers understand how OTP-01 affects cancer and the immune system. These biopsies are voluntary and will not affect participation in the study.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called OTP-01 for people with advanced solid tumors. The study is currently recruiting participants at 12 locations.

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

DRUGOTP-01

Intravenous (IV) Infusion


Locations(12)

Yale Cancer Center

New Haven, Connecticut, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

South Texas Accelerated Research Therapeutics (START) Midwest

Grand Rapids, Michigan, United States

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, United States

START Mountain Region

West Valley City, Utah, United States

Cancer Research SA

Adelaide, Australia

Chris O'Brien Lifehouse

Camperdown, Australia

Linear Clinical Research

Nedlands, Australia

START Dublin Early Phase Clinical Trials Unit

Dublin, Ireland

Auckland City Hospital

Auckland, New Zealand

Hospital de Santa-Maria-Centro Hospitalar Lisboa Norte (CHLN)

Lisbon, Portugal

Fundación Jiménez Díaz

Madrid, Spain

View Full Details on ClinicalTrials.gov

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

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NCT07266428


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