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RECRUITING
NCT07266428
PHASE1/PHASE2

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

Sponsor: Ottimo Pharma Limited

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

170

Start Date

2025-12-17

Completion Date

2028-12

Last Updated

2026-02-03

Healthy Volunteers

No

Interventions

DRUG

OTP-01

Intravenous (IV) Infusion

Locations (4)

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

Linear Clinical Research

Nedlands, Australia