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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Ottimo Pharma Limited
Study ID
NCT07266428
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OTP-01 — DRUG
    Intravenous (IV) Infusion

Study Details

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.

Key Dates

Start date
Dec 17, 2025
Status verified
May 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
170 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • Experimental: Monotherapy Dose Escalation with Backfill
  • Experimental: Monotherapy Dose Expansion

Primary Outcome Measure

Phase 1 and Phase 2A: Frequency and Severity of adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: C1D1 through EoT (up to 36 months) ]

Locations (4)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Glenn Hanna
[email protected]
877-338-7425
South Texas Accelerated Research Therapeutics (START) MidwestGrand RapidsMichigan49546
Andrew Sochacki
[email protected]
616-954-5554
Andrew Sochacki (PRINCIPAL_INVESTIGATOR)
South Texas Accelerated Research Therapeutics (START)San AntonioTexas78229
Amita Patnaik
[email protected]
210-593-5250
Amita Patnaik (PRINCIPAL_INVESTIGATOR)
START Mountain RegionWest Valley CityUtah84119
William McKean
[email protected]
810-907-4750
William McKean (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By research site
Dana-Farber Cancer Institute· Boston, MASouth Texas Accelerated Research Therapeutics (START) Midwest· Grand Rapids, MISouth Texas Accelerated Research Therapeutics (START)· San Antonio, TXSTART Mountain Region· West Valley City, UT

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