Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New Dual-Antibody drug takes aim at Hard-to-Treat cancers

NCT ID NCT07266428

Disease control Sponsor: Ottimo Pharma Limited Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 14, 2026 · Updated 3 times

Summary

This study tests OTP-01, a new drug that targets two cancer pathways (PD-1 and VEGFR2) at once, in 170 adults with advanced solid tumors that have stopped responding to standard treatments. The main goals are to find the best dose, check safety, and see if the drug can shrink tumors or slow their growth. Participants receive OTP-01 by IV infusion and undergo regular blood tests and scans.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
OTP-01 (a dual antibody targeting PD-1 and VEGFR2)
What this could lead to
If successful, this could lead to a new treatment option that shrinks tumors or slows their growth in people with advanced solid cancers.
What could go wrong
This is an early-phase trial with only 170 participants, so the drug may not work as hoped or could cause significant side effects. Results may not apply to all cancer types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 170 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Histologically or cytologically confirmed advanced (incurable, recurrent, unresectable, or metastatic) solid tumors. 1. 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. 2. 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. Measurable disease per RECIST v1.1. Additionally, patients with breast or ovarian cancer with non-measurable, evaluable disease are eligible. 3. ECOG performance status 0-1. 4. Life expectancy of at least 3 months. 5. Willing to provide a pretreatment tumor sample (either an archival sample or a sample obtained by pretreatment biopsy). 6. 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. 7. Adequate hematological, renal, and hepatic function. 8. Other protocol-defined inclusion criteria apply. Exclusion Criteria: 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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Advanced solid tumor are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    14 sites in 8 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ankara Oncology Training and Research Hospital

    RECRUITING

    Ankara, Turkey (Türkiye)

  • Auckland City Hospital

    RECRUITING

    Auckland, 1023, New Zealand

  • Cancer Research SA

    RECRUITING

    Adelaide, Australia

    Contact Email: •••••@•••••

  • Centro Gaucho Integrado

    RECRUITING

    Porto Alegre, 90850-170, Brazil

  • Chris O'Brien Lifehouse

    RECRUITING

    Camperdown, 2050, Australia

    Contact Email: •••••@•••••

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

    Contact Email: •••••@•••••

  • Fundación Jiménez Díaz

    RECRUITING

    Madrid, 28040, Spain

    Contact Email: •••••@•••••

  • Hospital de Santa-Maria-Centro Hospitalar Lisboa Norte (CHLN)

    RECRUITING

    Lisbon, 1649-036, Portugal

    Contact Email: •••••@•••••

  • Linear Clinical Research

    RECRUITING

    Nedlands, 6009, Australia

    Contact Email: •••••@•••••

  • START Dublin Early Phase Clinical Trials Unit

    RECRUITING

    Dublin, D07 R2WY, Ireland

    Contact Email: •••••@•••••

  • START Mountain Region

    RECRUITING

    West Valley City, Utah, 84119, United States

    Contact Email: •••••@•••••

  • South Texas Accelerated Research Therapeutics (START)

    RECRUITING

    San Antonio, Texas, 78229, United States

    Contact Email: •••••@•••••

  • South Texas Accelerated Research Therapeutics (START) Midwest

    RECRUITING

    Grand Rapids, Michigan, 49546, United States

    Contact Email: •••••@•••••

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06520, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.