🏛️ Verified NIH Record • Updated 2026-08-12

A Study of OTP-01, a Dual Paratopic PD-1/VEGFR2 Antibody, in Patients With Advanced Solid Tumors (NCT07266428)

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

🟢 Recruiting Phase1 / Phase2 💊 Investigational Drug / Biologic Sponsor: Ottimo Pharma Limited

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Yale Cancer Center — New Haven, Connecticut

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (14 Sites)

  • Yale Cancer Center — New Haven, Connecticut
  • Dana-Farber Cancer Institute — Boston, Massachusetts
  • South Texas Accelerated Research Therapeutics (START) Midwest — Grand Rapids, Michigan
  • South Texas Accelerated Research Therapeutics (START) — San Antonio, Texas
  • START Mountain Region — West Valley City, Utah
  • Cancer Research SA — Adelaide,
  • Chris O'Brien Lifehouse — Camperdown,
  • Linear Clinical Research — Nedlands,
  • Centro Gaucho Integrado — Porto Alegre,
  • START Dublin Early Phase Clinical Trials Unit — Dublin,
  • Auckland City Hospital — Auckland,
  • Hospital de Santa-Maria-Centro Hospitalar Lisboa Norte (CHLN) — Lisbon,
  • Fundación Jiménez Díaz — Madrid,
  • Ankara Oncology Training and Research Hospital — Ankara,

📞 Contact the Study Coordinator

Phone: (203) 432-9838

Email: vpr@yale.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗