RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

A Phase 1b/2a Trial to Evaluate Invobenitug Also Known as Procizumab (PCZ; AK1967) in Critical Cardiovascular Care.

Sponsor: 4TEEN4 Pharmaceuticals GmbH • ClinicalTrials.gov ID: NCT06832722

Registry updated: 2026-09-14

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Description

The objective of this Phase 1b/2a trial is to evaluate the safety, tolerability, and exploratory efficacy of invobenitug (also known as procizumab), a monoclonal antibody under development for the treatment of cardiogenic shock (CS). CS is a life-threatening hypoperfusion of vital organs that frequently results in death. In addition to safety and tolerability, pharmacokinetics and pharmacodynamics of invobenitug are evaluated to define the optimum phase 2 dose (P2D) of invobenitug.

Interventions

AK1967 (Invobenitug also known as Procizumab) (Drug)
DPP3 inhibition using the humanized monoclonal antibody AK1967 (Procizumab)
Placebo (Drug)
Application of placebo

Eligibility criteria

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).

Conditions

Shock, Cardiogenic

Locations

Yerevan medical scientific center — Yerevan, Armenia
Erebouni Mwdical Center — Yerevan, Armenia
Heart Center Aalst, AZORG — Aalst, Belgium
University Hospital Saint Pierre — Brussels, Belgium
Ghent University Hospital — Ghent, Belgium
University Hospital and Medical Faculty of Pilsen — Pilsen, Czechia
Charles University Motol University Hospital — Prague, Czechia
General University Hospital in Prague - FVN — Prague, Czechia
Institute of Clinical and Experimental Medicine - IKEM — Prague, Czechia
University Hospital Avicenne AP-HP — Bobigny, France
Département d'anesthésie-réanimation — Dijon, France
University Hospital Lille - Institut Cœur Poumon — Lille, France
University Hospital - Dupuytren Limoges — Limoges, France
Regional University Hospital Nancy - Hopitaux de Brabois — Nancy, France
Hôpital Pitié Salpêtrière — Paris, France
Lariboisière Hospital AP-HP — Paris, France
Deutsches Herzzentrum der Charite (DHZC) — Berlin, Germany
Universitätsklinikum Freiburg — Freiburg im Breisgau, Germany
University Medical Center Hamburg-Eppendorf — Hamburg, Germany
Herzzentrum Leipzig GmbH — Leipzig, Germany
Universitätsmedizin Mannheim — Mannheim, Germany
Radboud University Medical Center — Nijmegen, Netherlands
Uniersytecki Szpital Kliniczny w Białystoku — Bialystok, Poland
Górnośląskie Centrum Medyczne w Katowicach / Śląski Uniwersytet Medyczny w Katowicach — Katowice, Poland
Clinical University Hospital Poznań — Poznan, Poland
J. Mikulicz Radecki Clinical University Hospital Wrocław — Wroclaw, Poland
Clinical Hospital Center Bezanijska Kosa — Belgrade, Serbia
Institute for Cardiovascular Diseases of Vojvodina — Kamenitz, Serbia
Clinical Center Niš — Niš, Serbia
Fundación Pública Galega de Investigación Biomédica INIBIC — A Coruña, Spain
Fundació Hospital Universitari Vall d'Hebron — Barcelona, Spain
Fundació Hospital Universitari Vall d'Hebron — Barcelona, Spain
Hospital Clinic de Barcelona — Barcelona, Spain
Hospital de la Santa Creu i Sant Pau — Barcelona, Spain
L'Hospitalet de Llobregat — Barcelona, Spain
Fundación para la Investigación Biomédica del Hospital Universitario La Paz — Madrid, Spain
Hospital Universitario 12 De Octubre — Madrid, Spain

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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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