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

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: OTP-01

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia
    • Recruiting
    • Cancer Research SA
    • Contact: Meena Okera; Phone Number: 0883592565; Email: admin@crsa.au
  • Camperdown, Australia, 2050
    • Recruiting
    • Chris O'Brien Lifehouse
    • Contact: Man Hui; Phone Number: (02) 8514 0000; Email: infocentre@lh.org.au
  • Nedlands, Australia, 6009
    • Recruiting
    • Linear Clinical Research
    • Principal Investigator: Michael Millward
    • Contact: Michael Millward; Phone Number: 1300 546 327 / 08 6382 5110; Email: enquiries@linear.org.au
• Ireland
  • Dublin, Ireland, D07 R2WY
    • Recruiting
    • START Dublin Early Phase Clinical Trials Unit
    • Contact: Austin Duffy; Phone Number: 35318545766; Email: information@startresearch.com
• New Zealand
  • Auckland, New Zealand, 1023
    • Recruiting
    • Auckland City Hospital
    • Contact: Peter Fong; Phone Number: 09 367 0000; Email: customerservice@health.govt.nz
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Contact: Glenn Hanna; Phone Number: 877-338-7425; Email: info@ds.dfci.harvard.edu
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Recruiting
      • South Texas Accelerated Research Therapeutics (START) Midwest
      • Principal Investigator: Andrew Sochacki
      • Contact: Andrew Sochacki; Phone Number: 616-954-5554; Email: information@startresearch.com
  • Texas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • South Texas Accelerated Research Therapeutics (START)
      • Principal Investigator: Amita Patnaik
      • Contact: Amita Patnaik; Phone Number: 210-593-5250; Email: information@startresearch.com
  • Utah
    • West Valley City, Utah, United States, 84119
      • Recruiting
      • START Mountain Region
      • Principal Investigator: William McKean
      • Contact: William McKean; Phone Number: 810-907-4750; Email: information@startresearch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Histologically or cytologically confirmed advanced (incurable, recurrent, unresectable, or metastatic) solid tumors.

   1. For dose escalation cohort patients: patients must have a tumor type as defined in the protocol. Patients will have progression on or after or intolerance to most recent systemic therapy. Patients must have received approved standard therapy that is available to the patient that is known to confer clinical benefit, unless this therapy is contraindicated, intolerable to the patient, or is declined by the patient. The reason for treatment decline must be clearly documented in the medical record.
   2. For backfill cohorts: patients must have a tumor type as defined in the protocol. If patients decline an available standard therapeutic regimen known to confer benefit to enroll on this study, the discussion must be clearly documented in the medical record.
2. Measurable disease per RECIST v1.1. Additionally, patients with breast or ovarian cancer with non-measurable, evaluable disease are eligible.
3. ECOG performance status 0-1.
4. Life expectancy of at least 3 months.
5. Willing to provide a pretreatment tumor sample (either an archival sample or a sample obtained by pretreatment biopsy).
6. All toxicity resulting from prior cancer therapies must have resolved to NCI CTCAE v5.0 ≤ Grade 1 or pre-therapy baseline with the exception of alopecia or ≤ Grade 2 neuropathy.
7. Adequate hematological, renal, and hepatic function.
8. Other protocol-defined inclusion criteria apply.

Exclusion Criteria:

1. Receiving systemic corticosteroids at prednisone-equivalent dose of > 10 mg/day within 4 weeks prior to signing consent. Chronic systemic corticosteroid therapy for physiologic replacement (≤ 10 mg/day of prednisone equivalents) and the use of non-systemic corticosteroids (e.g., inhaled, topical, intra-nasal, intra-articular, or ophthalmic) are permitted
2. History of Grade 4 allergic or anaphylactic reaction to prior monoclonal antibody therapy or allergic reaction to any excipients within the investigational product
3. History of toxicity requiring permanent discontinuation of prior cancer immunotherapy
4. Have an active autoimmune disease that has required systemic treatment in past 2 years (replacement therapy is not considered a form of systemic treatment)
5. History of organ or stem cell transplant or need for immunosuppressive treatment
6. Have proteinuria > 2 + (within 7 days prior to initiation of study treatment).
7. Received any chemotherapy, immunotherapy or investigational anticancer therapy within 3 weeks or 5 half-lives (whichever is shorter; minimum of 2 weeks) prior to first dose of study drug
8. Definitive radiotherapy within 6 weeks and palliative radiation within 2 weeks prior to the first dose of study drug. If previously irradiated, lesions must have demonstrated clear-cut progression prior to being eligible for evaluation as target lesions
9. Other protocol and subprotocol-defined exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Monotherapy Dose Expansion	Drug: OTP-01; Intravenous (IV) Infusion
Experimental: Monotherapy Dose Escalation with Backfill	Drug: OTP-01; Intravenous (IV) Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Phase 1 and Phase 2A: Frequency and Severity of adverse events (AEs) and serious adverse events (SAEs)	C1D1 through EoT (up to 36 months)
Phase 2A - Progression Free Survival (PFS)	C1D1 through EoT (up to 36 months)
Phase 2A - Disease Control Rate (DCR)	C1D1 through EoT (up to 36 months)
Phase 2A - Duration of Response (DOR)	C1D1 through EoT (up to 36 months)
Phase 2A - Objective Response Rate (ORR)	C1D1 through EoT (up to 36 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1 and Phase 2A - plasma concentrations of OTP-01	As a function of time post-dosing	C1D1 through EOT (up to 36 months)
Phase 1 and Phase 2A - Area under the curve [AUC]		C1D1 through EOT (up to 36 months)
Phase 1 and Phase 2A - Maximum plasma concentration [Cmax]		C1D1 through EOT (up to 36 months)
Phase 1 and Phase 2A - Minimum plasma concentration [Cmin]		C1D1 through EOT (up to 36 months)
Phase 1 and Phase 2A - Time of maximum concentration [Tmax]		C1D1 through EOT (up to 36 months)
Phase 1 and Phase 2A - Half-life [t1/2]		C1D1 through EOT (up to 36 months)
Phase 1 and Phase 2A - Clearance [CL]		C1D1 through EOT (up to 36 months)
Phase 1 - Progression Free Survival (PFS)		C1D1 through EoT (up to 36 months)
Phase 1 - Disease Control Rate (DCR)		C1D1 through EoT (up to 36 months)
Phase 1 - Duration of Response (DOR)		C1D1 through EoT (up to 36 months)
Phase 1 - Objective Response Rate (ORR)		C1D1 through EoT (up to 36 months)

Collaborators and Investigators

• Sponsor: Ottimo Pharma Limited
• Investigators: Study Director: Katherine Bell-McGuinn, Ottimo Pharma Limited

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: November 16, 2025
• First Submitted That Met QC Criteria: November 25, 2025
• First Posted (Actual): December 5, 2025

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: advanced solid tumors
• Other Study ID Numbers: OTP-01-101; 2025-524111-37-00 (Ctis); U1111-1329-6711 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes