Advanced Solid TumorsPhase 1/2NCT07266428
A Study of OTP-01, a Dual Paratopic PD-1/VEGFR2 Antibody, in Patients With Advanced Solid Tumors
A Phase 1/2 study testing OTP-01 in people with Advanced Solid Tumors, run by Ottimo Pharma Limited at 21 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- OTP-01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 21 sitesin 8 countries
- Study dates
- 17 Dec 2025to Dec 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed advanced (incurable, recurrent, unresectable, or metastatic) solid tumors.
- 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.
- 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.
- Measurable disease per RECIST v1.1. Additionally, patients with breast or ovarian cancer with non-measurable, evaluable disease are eligible.
- ECOG performance status 0-1.
- Life expectancy of at least 3 months.
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- Willing to provide a pretreatment tumor sample (either an archival sample or a sample obtained by pretreatment biopsy).
- 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.
- Adequate hematological, renal, and hepatic function.
- Other protocol-defined inclusion criteria apply.
Who cannot join
- 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
- History of Grade 4 allergic or anaphylactic reaction to prior monoclonal antibody therapy or allergic reaction to any excipients within the investigational product
- History of toxicity requiring permanent discontinuation of prior cancer immunotherapy
- Have an active autoimmune disease that has required systemic treatment in past 2 years (replacement therapy is not considered a form of systemic treatment)
- History of organ or stem cell transplant or need for immunosuppressive treatment
- Have proteinuria > 2 + (within 7 days prior to initiation of study treatment).
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- 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
- 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
- Other protocol and subprotocol-defined exclusion criteria apply
Trial locations and contacts
21 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
21 sites in 8 countries
United States5 sites, 5 recruiting
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Glenn Hanna, 877-338-7425, info@ds.dfci.harvard.edu
- Recruiting
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, Michigan, 49546
Andrew Sochacki, 616-954-5554, information@startresearch.com
Andrew Sochacki
- Recruiting
Yale Cancer Center
New Haven, Connecticut, 06520
So Yeon Kim, 203-432-9838, vpr@yale.edu
- Recruiting
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, 78229
Amita Patnaik, 210-593-5250, information@startresearch.com
Amita Patnaik
- Recruiting
START Mountain Region
West Valley City, Utah, 84119
William McKean, 810-907-4750, information@startresearch.com
William McKean
Brazil4 sites, 4 recruiting
- Recruiting
Oncosite - Centro de Pesquisa Clinica Em Oncologia
Ijuí, 98700-000
Fabio Franke, 55 55 3195 0504, contato@oncosite.com
- Recruiting
Centro Gaucho Integrado
Porto Alegre, 90850-170
Alan Azambuja, 55 51 99990-1206, cep.ucmd@maededeus.com.br
Alan Azambuja
- Recruiting
Instituto do Cancer do Estado de São Paulo (ICESP)
São Paulo, 01246-000
Camila Venchiarutti, 55 11 3893 2000, onco.pg@usp.br
- Recruiting
Oncostar
São Paulo, 04543-000
Paulo Gehm Hoff, 55 11 3003 6373, giovanna.maximiano@idor.org
Spain4 sites, 4 recruiting
- Recruiting
NEXT Oncology Barcelona
Barcelona, 08023
Fabricio Racca, 34 932 381 661, pacientes.nextbcn@nextoncology.eu
- Recruiting
Fundación Jiménez Díaz
Madrid, 28040
Victor Moreno, +34 91 550 48 00 ext. 2805, information@startresearch.com
- Recruiting
NEXT Oncology Madrid
Madrid, 28223
Valentina Boni, 34 932 381 661, nxtmad_coordinacion@nextoncology.eu
- Recruiting
START - Rioja
Rioja, 26006
Maria Jose de Miguel Luken, 0034 941 27 87 60, information@startresearch.com
Australia3 sites, 3 recruiting
- Recruiting
Cancer Research SA
Adelaide
Meena Okera, 0883592565, admin@crsa.au
- Recruiting
Chris O'Brien Lifehouse
Camperdown, 2050
Man Hui, (02) 8514 0000, infocentre@lh.org.au
- Recruiting
Linear Clinical Research
Nedlands, 6009
Michael Millward, 1300 546 327 / 08 6382 5110, enquiries@linear.org.au
Michael Millward
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara, 06800
Murat Sendur, 90 312 552 60 00, ankarasehir@saglik.gov.tr
- Recruiting
Ankara Oncology Training and Research Hospital
Ankara
Ozturk Ates, 90 312 336 09 09, iletisim@onkoloji.gov.tr
Ozturk Ates
Ireland1 site, 1 recruiting
- Recruiting
START Dublin Early Phase Clinical Trials Unit
Dublin, D07 R2WY
Austin Duffy, 35318545766, information@startresearch.com
New Zealand1 site, 1 recruiting
- Recruiting
Auckland City Hospital
Auckland, 1023
Peter Fong, 09 367 0000, customerservice@health.govt.nz
Portugal1 site, 1 recruiting
- Recruiting
Hospital de Santa-Maria-Centro Hospitalar Lisboa Norte (CHLN)
Lisbon, 1649-036
Andre Mansinho, +351217805000, information@startresearch.com
About this study
Official title: 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:
Read more
- 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
- Advanced Solid Tumors
- Being tested
- OTP-01
- Keywords
- advanced solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTP-01Drug
Intravenous (IV) Infusion
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy Dose Escalation with Backfill | Experimental | Not described Receives: Drug: OTP-01 |
| Monotherapy Dose Expansion | Experimental | Not described Receives: Drug: OTP-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1 and Phase 2A: Frequency and Severity of adverse events (AEs) and serious adverse events (SAEs)
Measured: C1D1 through EoT (up to 36 months)
Phase 2A - Progression Free Survival (PFS)
Measured: C1D1 through EoT (up to 36 months)
Phase 2A - Disease Control Rate (DCR)
Measured: C1D1 through EoT (up to 36 months)
Phase 2A - Duration of Response (DOR)
Measured: C1D1 through EoT (up to 36 months)
Phase 2A - Objective Response Rate (ORR)
Measured: C1D1 through EoT (up to 36 months)
Secondary outcomes (11)
Phase 1 and Phase 2A - plasma concentrations of OTP-01
As a function of time post-dosing
Measured: C1D1 through EOT (up to 36 months)
Phase 1 and Phase 2A - Area under the curve [AUC]
Measured: C1D1 through EOT (up to 36 months)
Phase 1 and Phase 2A - Maximum plasma concentration [Cmax]
Measured: C1D1 through EOT (up to 36 months)
Phase 1 and Phase 2A - Minimum plasma concentration [Cmin]
Measured: C1D1 through EOT (up to 36 months)
Phase 1 and Phase 2A - Time of maximum concentration [Tmax]
Measured: C1D1 through EOT (up to 36 months)
Phase 1 and Phase 2A - Half-life [t1/2]
Measured: C1D1 through EOT (up to 36 months)
Phase 1 and Phase 2A - Clearance [CL]
Measured: C1D1 through EOT (up to 36 months)
Phase 1 - Progression Free Survival (PFS)
Measured: C1D1 through EoT (up to 36 months)
Phase 1 - Disease Control Rate (DCR)
Measured: C1D1 through EoT (up to 36 months)
Phase 1 - Duration of Response (DOR)
Measured: C1D1 through EoT (up to 36 months)
Phase 1 - Objective Response Rate (ORR)
Measured: C1D1 through EoT (up to 36 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start17 Dec 2025
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase 1 monotherapy dose escalation with backfill followed by Phase 2A monotherapy dose expansion
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottimo Pharma Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katherine Bell-McGuinn, Study director, Ottimo Pharma Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266428
- Sponsor's protocol ID
- OTP-01-101
- Other IDs
- 2025-524111-37-00, U1111-1329-6711, 2025
- Status last verified
- Oct 2026
- First submitted
- 16 Nov 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2A Study of OTP-01, a Dual Paratopic PD-1/VEGFR2 Antibody, in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07266428
- Acronym / sponsor ID
- OTP-01-101
- Conditions
- Advanced Solid Tumors
- Keywords
- advanced solid tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Ottimo Pharma LimitedIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 1 monotherapy dose escalation with backfill followed by Phase 2A monotherapy dose expansion
| Arm | Type | Receives |
|---|---|---|
| Monotherapy Dose Escalation with Backfill | Experimental | Drug: OTP-01 |
| Monotherapy Dose Expansion | Experimental | Drug: OTP-01 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologically confirmed advanced (incurable, recurrent, unresectable, or metastatic) solid tumors.
- Measurable disease per RECIST v1.1. Additionally, patients with breast or ovarian cancer with non-measurable, evaluable disease are eligible.
- ECOG performance status 0-1.
- Life expectancy of at least 3 months.
- Willing to provide a pretreatment tumor sample (either an archival sample or a sample obtained by pretreatment biopsy).
Key exclusion criteria (9 listed)
- 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
- History of Grade 4 allergic or anaphylactic reaction to prior monoclonal antibody therapy or allergic reaction to any excipients within the investigational product
- History of toxicity requiring permanent discontinuation of prior cancer immunotherapy
- Have an active autoimmune disease that has required systemic treatment in past 2 years (replacement therapy is not considered a form of systemic treatment)
- History of organ or stem cell transplant or need for immunosuppressive treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OTP-01Intravenous (IV) Infusion | Drug | Monotherapy Dose Escalation with Backfill, Monotherapy Dose Expansion |
Primary outcome
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)
Phase 2A - Progression Free Survival (PFS)
Time frame: C1D1 through EoT (up to 36 months)
Phase 2A - Disease Control Rate (DCR)
Time frame: C1D1 through EoT (up to 36 months)
Phase 2A - Duration of Response (DOR)
Time frame: C1D1 through EoT (up to 36 months)
Phase 2A - Objective Response Rate (ORR)
Time frame: C1D1 through EoT (up to 36 months)
11 secondary outcomes
Phase 1 and Phase 2A - plasma concentrations of OTP-01
Time frame: C1D1 through EOT (up to 36 months)
Phase 1 and Phase 2A - Area under the curve [AUC]
Time frame: C1D1 through EOT (up to 36 months)
Phase 1 and Phase 2A - Maximum plasma concentration [Cmax]
Time frame: C1D1 through EOT (up to 36 months)
Phase 1 and Phase 2A - Minimum plasma concentration [Cmin]
Time frame: C1D1 through EOT (up to 36 months)
Phase 1 and Phase 2A - Time of maximum concentration [Tmax]
Time frame: C1D1 through EOT (up to 36 months)
Phase 1 and Phase 2A - Half-life [t1/2]
Time frame: C1D1 through EOT (up to 36 months)
Phase 1 and Phase 2A - Clearance [CL]
Time frame: C1D1 through EOT (up to 36 months)
Phase 1 - Progression Free Survival (PFS)
Time frame: C1D1 through EoT (up to 36 months)
Phase 1 - Disease Control Rate (DCR)
Time frame: C1D1 through EoT (up to 36 months)
Phase 1 - Duration of Response (DOR)
Time frame: C1D1 through EoT (up to 36 months)
Phase 1 - Objective Response Rate (ORR)
Time frame: C1D1 through EoT (up to 36 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
South Texas Accelerated Research Therapeutics (START) Midwest
Grand Rapids, United States
Katherine Bell-McGuinn study director
Ottimo Pharma Limited
21 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing OTP-01 in people with Advanced Solid Tumors, run by Ottimo Pharma Limited at 21 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States, Brazil, Spain, Australia, Turkey (Türkiye) and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.