OTP-01 for Advanced solid tumors

Inclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- ECOG performance status 0-1."}
• {"criterion_text":"- Life expectancy of at least 3 months."}
• {"criterion_text":"- Willing to provide a pretreatment tumor sample (either an archival sample or a sample obtained by pretreatment biopsy)."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Adequate hematological, renal, and hepatic function"}
• {"criterion_text":"- Other protocol-defined inclusion criteria apply."}
• {"criterion_text":"- Measurable disease per RECIST v1.1. Additionally, patients with breast or ovarian cancer with non-measurable, evaluable disease are eligible."}

Exclusion criteria

• {"criterion_text":"- 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."}
• {"criterion_text":"- History of Grade 4 allergic or anaphylactic reaction to prior monoclonal antibody therapy or allergic reaction to any excipients within the investigational product."}
• {"criterion_text":"- History of toxicity requiring permanent discontinuation of prior cancer immunotherapy"}
• {"criterion_text":"- Have an active autoimmune disease that has required systemic treatment in past 2 years (replacement therapy is not considered a form of systemic treatment)"}
• {"criterion_text":"- History of organ or stem cell transplant or need for immunosuppressive treatment"}
• {"criterion_text":"- Have proteinuria > 2 + (within 7 days prior to initiation of study treatment)."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Other protocol and subprotocol-defined exclusion criteria apply."}

Primary endpoints

• {"endpoint_text":"- Phase 1 - Inclusive of all aspects of safety, tolerability, biologic activity, PK, pharmacodynamics (PD) and preliminary efficacy","definition_or_measurement_approach":"Assessment includes safety and tolerability, biologic activity, PK and PD measurements and preliminary efficacy assessments (PK/PD sampling and clinical/laboratory assessments as specified in protocol)."}
• {"endpoint_text":"- Phase 1 - Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)","definition_or_measurement_approach":"Frequency and severity of AEs and SAEs as reported during the study; adverse events referenced in protocol with NCI CTCAE v5.0 used elsewhere in protocol."}
• {"endpoint_text":"- Phase 2A - Objective Response Rate (ORR)","definition_or_measurement_approach":"ORR to be assessed per RECIST v1.1 (as stated in trial objectives)."}
• {"endpoint_text":"- Phase 2A - Duration of response (DOR)","definition_or_measurement_approach":"Duration of response assessed for responding patients (per RECIST v1.1 as used for tumour response assessments)."}
• {"endpoint_text":"- Phase 2A - Disease control rate (DCR)","definition_or_measurement_approach":"Disease control rate assessed per RECIST v1.1."}
• {"endpoint_text":"- Phase 2A - Progression free survival (PFS)","definition_or_measurement_approach":"PFS assessed using standard definitions for progression (tumour assessments per RECIST v1.1)."}
• {"endpoint_text":"- Phase 2A - Frequency and severity of AEs and SAEs","definition_or_measurement_approach":"Frequency and severity of AEs and SAEs as reported during Phase 2A (graded per NCI CTCAE v5.0 where referenced in protocol)."}

Secondary endpoints

• {"endpoint_text":"- Phase 1 - Objective Response Rate (ORR)","definition_or_measurement_approach":"ORR assessed per RECIST v1.1."}
• {"endpoint_text":"- Phase 1 - Duration of response (DOR)","definition_or_measurement_approach":"DOR assessed per RECIST v1.1."}
• {"endpoint_text":"- Phase 1 - Disease control rate (DCR)","definition_or_measurement_approach":"DCR assessed per RECIST v1.1."}
• {"endpoint_text":"- Phase 1 - Progression free survival (PFS)","definition_or_measurement_approach":"PFS assessed using tumour assessments per RECIST v1.1."}
• {"endpoint_text":"- Phase 1 and 2A- Plasma concentrations of OTP-01 as a function of time post-dosing","definition_or_measurement_approach":"Plasma concentration-time profiles of OTP-01 measured from PK samples collected post-dose."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"PK parameters to be derived from plasma concentration-time data (e.g., AUC, Cmax, Cmin, Tmax, t1/2, CL) according to protocol-specified PK analysis methods."}

Ireland

Earliest CTIS Part Ii Submission Date

25-03-2026

Latest Decision Or Authorization Date

22-04-2026

Processing Time Days

28

Number Of Sites

1

Number Of Participants

9

Spain

Earliest CTIS Part Ii Submission Date

25-03-2026

Latest Decision Or Authorization Date

22-04-2026

Processing Time Days

28

Number Of Sites

1

Number Of Participants

23

Portugal

Earliest CTIS Part Ii Submission Date

06-03-2026

Latest Decision Or Authorization Date

11-05-2026

Processing Time Days

66

Number Of Sites

1

Number Of Participants

9

Primary sponsor

Full Name

Ottimo Pharma Limited

Organisation Type

Pharmaceutical company

Country Of Registered Address

United Kingdom

Contract research organisations

Name

Medpace Finland Oy

Responsibilities

Regulatory submissions support (contact RS-Advisor-Support@medpace.com) and the sponsor duties codes listed for this organisation: 1,12,13,2,3,4,5,6,7,8

Third parties

• {"country":"Finland","full_name":"Medpace Finland Oy","duties_or_roles":"Codes: 1,12,13,2,3,4,5,6,7,8 (as listed in sponsor duties); contact RS-Advisor-Support@medpace.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Scilucent LLC","duties_or_roles":"Codes: 11 (as listed in sponsor duties)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"Codes: 4 (as listed in sponsor duties)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Neogenomics Laboratories Inc.","duties_or_roles":"Codes: 4 (as listed in sponsor duties)","organisation_type":"Laboratory/Research/Testing facility"}