Actively Recruiting
A Study of OTP-01, a Dual Paratopic PD-1/VEGFR2 Antibody, in Patients With Advanced Solid Tumors
Led by Ottimo Pharma Limited · Updated on 2026-05-13
170
Participants Needed
9
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study of OTP-01, a Dual Paratopic PD-1/VEGFR2 Antibody, in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults with histologically or cytologically confirmed advanced (incurable, recurrent, unresectable, or metastatic) solid tumors
- For dose escalation cohort, tumor type must be defined in the protocol, with disease progression or intolerance to most recent systemic therapy
- For backfill cohorts, tumor type must be defined in the protocol; patients declining standard therapy must have documented reasons
- Measurable disease per RECIST v1.1; breast or ovarian cancer patients with non-measurable but evaluable disease are eligible
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Willingness to provide a pretreatment tumor sample (archival or biopsy)
- Toxicity from prior cancer treatments resolved to Grade 1 or baseline (except alopecia or Grade 2 neuropathy)
- Adequate blood, kidney, and liver function
- Other protocol-defined inclusion criteria apply
You will not qualify if you...
- Use of systemic corticosteroids at prednisone-equivalent dose > 10 mg/day within 4 weeks before consent
- History of Grade 4 allergic or anaphylactic reaction to monoclonal antibody therapy or to investigational product excipients
- History of toxicity requiring permanent stop of prior cancer immunotherapy
- Active autoimmune disease needing systemic treatment in past 2 years (replacement therapy allowed)
- History of organ or stem cell transplant or need for immunosuppressive treatment
- Proteinuria greater than 2+ within 7 days before study treatment
- Received chemotherapy, immunotherapy, or investigational anticancer therapy within 3 weeks or 5 half-lives before first study drug dose
- Definitive radiotherapy within 6 weeks or palliative radiation within 2 weeks before first study drug dose
- Other protocol and subprotocol-defined exclusion criteria apply
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
2
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
3
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States, 78229
Actively Recruiting
4
START Mountain Region
West Valley City, Utah, United States, 84119
Actively Recruiting
5
Cancer Research SA
Adelaide, Australia
Actively Recruiting
6
Chris O'Brien Lifehouse
Camperdown, Australia, 2050
Actively Recruiting
7
Linear Clinical Research
Nedlands, Australia, 6009
Actively Recruiting
8
START Dublin Early Phase Clinical Trials Unit
Dublin, Ireland, D07 R2WY
Actively Recruiting
9
Auckland City Hospital
Auckland, New Zealand, 1023
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
2
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