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

NCT07266428 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2026-05-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

OTP-01

Intravenous (IV) Infusion

Sponsors & Collaborators

  • Ottimo Pharma Limited

    lead INDUSTRY

Principal Investigators

  • Katherine Bell-McGuinn · Ottimo Pharma Limited

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-17
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Ireland
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07266428 on ClinicalTrials.gov