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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Ottimo Pharma Limited

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

28 Apr 2026 → ongoing

Decision date (initial)

2026-04-17

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Ottimo Pharma Limited

External identifiers

EU CT number

2025-524111-37-00

WHO UTN

U1111-1329-6711

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Efficacy, Pharmacodynamic

Phase 1 - To determine the recommended Phase 2 dose (RP2D) of OTP-01
Phase 1 - To characterize the safety and tolerability of OTP-01
Phase 2A - To assess the preliminary anti-tumor activity of OTP-01 using RECIST v1.1
Phase 2A - To further characterize the safety and tolerability of OTP-01

Secondary objectives 2

1. Phase 1 - To assess the preliminary anti-tumor activity of OTP-01 using RECIST v1.1
2. Phase 1 and Phase 2A - To characterize the pharmacokinetics (PK) profile of OTP-01

Conditions and MedDRA coding

advanced solid tumors

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Histologically or cytologically confirmed advanced (incurable, recurrent, unresectable, or metastatic) solid tumors. a.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. b.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. ECOG performance status 0-1.
3. Life expectancy of at least 3 months.
4. Willing to provide a pretreatment tumor sample (either an archival sample or a sample obtained by pretreatment biopsy).
5. 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.
6. Adequate hematological, renal, and hepatic function
7. Other protocol-defined inclusion criteria apply.
8. Measurable disease per RECIST v1.1. Additionally, patients with breast or ovarian cancer with non-measurable, evaluable disease are eligible.

Exclusion criteria 9

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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 7

1. Phase 1 - Inclusive of all aspects of safety, tolerability, biologic activity, PK, pharmacodynamics (PD) and preliminary efficacy
2. Phase 1 - Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)
3. Phase 2A - Objective Response Rate (ORR)
4. Phase 2A - Duration of response (DOR)
5. Phase 2A - Disease control rate (DCR)
6. Phase 2A - Progression free survival (PFS)
7. Phase 2A - Frequency and severity of AEs and SAEs

Secondary endpoints 6

1. Phase 1 - Objective Response Rate (ORR)
2. Phase 1 - Duration of response (DOR)
3. Phase 1 - Disease control rate (DCR)
4. Phase 1 - Progression free survival (PFS)
5. Phase 1 and 2A- Plasma concentrations of OTP-01 as a function of time post-dosing
6. Phase 1 and 2A- PK parameters (area under the curve [AUC], maximum plasma concentration [Cmax], minimum plasma concentration [Cmin], time of maximum concentration [Tmax], half-life [t1/2], clearance [CL]) for single (first) dose and multiple doses

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Ottimo Pharma Limited

Sponsor organisation

Ottimo Pharma Limited

Address

Innovation House, Innovation Way, Discovery Park Innovation Way Discovery Park

City

Sandwich

Postcode

CT13 9FF

Country

United Kingdom

Scientific contact point

Organisation

Ottimo Pharma Limited

Contact name

Regulatory submissions

Public contact point

Organisation

Ottimo Pharma Limited

Contact name

Regulatory submissions

Third parties 4

Locations

3 EU/EEA countries · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 20 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications