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New antibody drug targets deadly heart shock in early trial

NCT ID NCT06832722

Disease control Sponsor: 4TEEN4 Pharmaceuticals GmbH 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 15, 2026 · Updated 6 times

Summary

This early-stage trial tests a new antibody drug called procizumab in 130 people with cardiogenic shock, a life-threatening condition where the heart cannot pump enough blood. The drug blocks a protein called DPP3, which is linked to worse outcomes. The main goal is to check safety and find the right dose, not yet to prove it works.

What this could mean

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

Active substance
procizumab (also called invobenitug or AK1967), a monoclonal antibody
What this could lead to
If it works, this could point toward a new treatment for cardiogenic shock, a life-threatening condition with few options.
What could go wrong
This is an early phase 1b/2a trial with only 130 participants, so it is primarily testing safety and dosing. The drug may not improve survival or heart function, and side effects are unknown.

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 90 people

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

Started

Jul 2025

Expected to finish

Dec 2026

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 to 80 years

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. Signed informed consent. 2. Diagnosis of CS based on the following entry criteria: 1. Need for ongoing vasopressors and/or inotropes to maintain a MAP ≥ 65 mmHg or SBP ≥ 90 mmHg 2. Lactate ≥ 2.0 mmol/L 3. High DPP3 concentration ≥ 30 ng/mL 3. Etiology of CS must be one of the following: ACS, septic (according to SEPSIS 3 criteria) or adHF origin Exclusion Criteria: 4. Patients who will be receiving vasopressors and/or inotropes for more than 16 hours prior to receiving the IMP. 5. Patients being longer than 24 hours in the ICU at the time of randomization. 6. Patients below the age of 18 or above 80 years. 7. Patients receiving Ang II and/or levosimendan 8. Patients with known allergies or hypersensitivity to the IMP or its excipients or any related medication. 9. Stroke or transient ischemic attack within the last 3 months. 10. SCAI Shock Stage E. 11. Reduced life expectancy of less than 6 months due to comorbidities (prior to shock onset). 12. Very severe frailty, or moribund condition or presence of clinical circumstances indicating imminent death. 13. Only for Part 1: Patients on cannula-based MCS (including VV and VA-ECMO, impella or left ventricular assist device of any type (excluding IABP)) or on renal replacement therapy. Patients who are treated by impella and/or ECMO but have no evidence of hemolysis during screening can be enrolled in the trial. 14. Patients exceeding a maximum body weight of 120 kg (EU, Armenia, Serbia) and 150 kg (US). 15. CPR lasting more than 15 minutes and/or the patient is not conscious at randomization. 16. Primary hypertrophic or restrictive cardiomyopathy or congenital heart disease or systemic illness known to be associated with infiltrative heart disease. 17. Pericardial constriction. 18. Sustained SBP \> 120 mmHg during the hour prior to randomization. 19. Known severe chronic liver disease (Model for End-Stage Liver Disease (MELD) Score \>30), known severe chronic pulmonary disease (including COPD classification GOLD4 and/or chronic oxygen therapy and/or restrictive chronic pulmonary failure and/or severe interstitial lung disease), known severe thyroid disease, known CKD with eGFR \<20 ml/min/1.73 m2 or chronic dialysis. 20. Patients with untreated sepsis. 21. Patients with valvular heart diseases as the primary cause of cardiogenic shock. 22. Other known causes of shock, namely 1. Hypovolemia 2. Hemorrhage 3. Anaphylaxis 4. Intoxication (e.g., drug-induced shock) 5. Dynamic left ventricular outflow tract obstruction 6. isolated right heart failure, including cardiac tamponade and/or pulmonary embolism 7. Known mechanical complications due to myocardial infarction, including papillary muscle rupture, ventricular septal rupture, free wall rupture 8. Inappropriate pacing or shock resulting from ICD malfunction 23. Patients who have severe immune suppression: recent (\<3 months) chemotherapy and/or severe neutropenia (neutrophile count \<500 cells/mm3) and/or chronic high glucocorticoid dose (≥0.5 mg/kg per day of prednisone equivalent) and/or recent (\<3 months) organ transplantation. 24. Patients who have undergone any form of surgery in the last 7 days, except 1) minor surgeries such as cosmetic surgeries, skin surgery, dental surgery and impella implantation 2) surgery for peritonitis with adequate source control, which are allowed. 25. Women who are pregnant or breastfeeding. 26. Patients who are currently enrolled in another clinical trial, or who have participated in such trials within one month prior to randomization. 27. Any reason that the investigator anticipates that the patient will be unable to complete the protocol or its required procedures (US only).

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Conditions

The condition(s) this trial relates to.

cardiogenic shock Shock, Cardiogenic

As listed by the trial registrant

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

Shock, cardiogenic

How to take part

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

  1. The places running it

    37 sites in 9 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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

  • Charles University Motol University Hospital

    RECRUITING

    Prague, Czechia

  • Clinical Center Niš

    NOT_YET_RECRUITING

    Niš, Serbia

  • Clinical Hospital Center Bezanijska Kosa

    NOT_YET_RECRUITING

    Belgrade, Serbia

  • Clinical University Hospital Poznań

    RECRUITING

    Poznan, Poland

  • Deutsches Herzzentrum der Charite (DHZC)

    NOT_YET_RECRUITING

    Berlin, Germany

  • Département d'anesthésie-réanimation

    NOT_YET_RECRUITING

    Dijon, 21000, France

  • Erebouni Mwdical Center

    NOT_YET_RECRUITING

    Yerevan, 0087, Armenia

  • Fundació Hospital Universitari Vall d'Hebron

    NOT_YET_RECRUITING

    Barcelona, Spain

  • Fundació Hospital Universitari Vall d'Hebron

    NOT_YET_RECRUITING

    Barcelona, Spain

  • Fundación Pública Galega de Investigación Biomédica INIBIC

    NOT_YET_RECRUITING

    A Coruña, Spain

  • Fundación para la Investigación Biomédica del Hospital Universitario La Paz

    NOT_YET_RECRUITING

    Madrid, Spain

  • General University Hospital in Prague - FVN

    RECRUITING

    Prague, Czechia

  • Ghent University Hospital

    NOT_YET_RECRUITING

    Ghent, Belgium

  • Górnośląskie Centrum Medyczne w Katowicach / Śląski Uniwersytet Medyczny w Katowicach

    RECRUITING

    Katowice, Poland

  • Heart Center Aalst, AZORG

    RECRUITING

    Aalst, Belgium

  • Herzzentrum Leipzig GmbH

    NOT_YET_RECRUITING

    Leipzig, Germany

  • Hospital Clinic de Barcelona

    NOT_YET_RECRUITING

    Barcelona, Spain

  • Hospital Universitario 12 De Octubre

    NOT_YET_RECRUITING

    Madrid, Spain

  • Hospital de la Santa Creu i Sant Pau

    NOT_YET_RECRUITING

    Barcelona, Spain

  • Hôpital Pitié Salpêtrière

    NOT_YET_RECRUITING

    Paris, 75651, France

  • Institute for Cardiovascular Diseases of Vojvodina

    NOT_YET_RECRUITING

    Kamenitz, Serbia

  • Institute of Clinical and Experimental Medicine - IKEM

    RECRUITING

    Prague, Czechia

  • J. Mikulicz Radecki Clinical University Hospital Wrocław

    RECRUITING

    Wroclaw, Poland

  • L'Hospitalet de Llobregat

    NOT_YET_RECRUITING

    Barcelona, Spain

  • Lariboisière Hospital AP-HP

    RECRUITING

    Paris, France

  • Radboud University Medical Center

    RECRUITING

    Nijmegen, Netherlands

  • Regional University Hospital Nancy - Hopitaux de Brabois

    RECRUITING

    Nancy, France

  • Uniersytecki Szpital Kliniczny w Białystoku

    RECRUITING

    Bialystok, Poland

  • University Hospital - Dupuytren Limoges

    RECRUITING

    Limoges, France

  • University Hospital Avicenne AP-HP

    RECRUITING

    Bobigny, France

  • University Hospital Lille - Institut Cœur Poumon

    RECRUITING

    Lille, France

  • University Hospital Saint Pierre

    RECRUITING

    Brussels, Belgium

  • University Hospital and Medical Faculty of Pilsen

    RECRUITING

    Pilsen, Czechia

  • University Medical Center Hamburg-Eppendorf

    NOT_YET_RECRUITING

    Hamburg, Germany

  • Universitätsklinikum Freiburg

    NOT_YET_RECRUITING

    Freiburg im Breisgau, Germany

  • Universitätsmedizin Mannheim

    NOT_YET_RECRUITING

    Mannheim, Germany

  • Yerevan medical scientific center

    NOT_YET_RECRUITING

    Yerevan, 0014, Armenia

More trials for these conditions

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