Actively Recruiting
Invobenitug Also Known as Procizumab (PCZ; AK1967) in Critical Cardiovascular Care
Led by 4TEEN4 Pharmaceuticals GmbH · Updated on 2026-04-23
130
Participants Needed
20
Research Sites
72 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this Phase 1b trial is to evaluate the safety and tolerability of 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 procizumab are evaluated to define the optimum phase 2 dose (P2D) of procizumab.
CONDITIONS
Official Title
Invobenitug Also Known as Procizumab (PCZ; AK1967) in Critical Cardiovascular Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Diagnosis of cardiogenic shock requiring ongoing vasopressors or inotropes to maintain mean arterial pressure 65 mmHg or systolic blood pressure 90 mmHg
- Blood lactate level 2.0 mmol/L
- High circulating dipeptidyl peptidase 3 (cDPP3) concentration 30 ng/mL
- Cardiogenic shock caused by acute coronary syndrome, septic origin, or acute decompensated heart failure
- Age between 18 and 80 years
You will not qualify if you...
- Receiving vasopressors and/or inotropes for more than 16 hours before study drug administration
- More than 24 hours in the intensive care unit at randomization
- Age below 18 or above 80 years
- Receiving angiotensin II and/or levosimendan
- Known allergies or hypersensitivity to the investigational drug or related medications
- Stroke or transient ischemic attack within the last 3 months
- SCAI Shock Stage E
- Life expectancy less than 6 months due to other illnesses before shock onset
- Very severe frailty, moribund condition, or signs of imminent death
- For Part 1 only: use of cannula-based mechanical circulatory support devices (except intra-aortic balloon pump) or renal replacement therapy unless no hemolysis evidence
- Body weight over 120 kg
- Cardiopulmonary resuscitation lasting more than 15 minutes or unconscious at randomization
- Primary hypertrophic or restrictive cardiomyopathy, congenital heart disease, or infiltrative heart disease
- Pericardial constriction
- Sustained systolic blood pressure over 120 mmHg during the hour before randomization
- Severe chronic liver disease (MELD Score >30), severe chronic lung disease, severe thyroid disease, chronic kidney disease with eGFR < 20 ml/min/1.73 m2, or chronic dialysis
- Untreated sepsis
- Valvular heart diseases as the main cause of cardiogenic shock
- Other shock causes such as hypovolemia, hemorrhage, anaphylaxis, intoxication, dynamic left ventricular outflow tract obstruction, isolated right heart failure, mechanical complications from myocardial infarction, or device malfunction
- Severe immune suppression from recent chemotherapy, severe neutropenia, high-dose glucocorticoids, or recent organ transplantation
- Surgery within the last 7 days except minor procedures or controlled peritonitis surgery
- Pregnancy or breastfeeding
- Participation in another clinical trial within one month prior to randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Yerevan medical scientific center
Yerevan, Armenia, 0014
Not Yet Recruiting
2
Erebouni Mwdical Center
Yerevan, Armenia, 0087
Not Yet Recruiting
3
Heart Center Aalst, AZORG
Aalst, Belgium
Actively Recruiting
4
University Hospital Saint Pierre
Brussels, Belgium
Actively Recruiting
5
University Hospital and Medical Faculty of Pilsen
Pilsen, Czechia
Actively Recruiting
6
Charles University Motol University Hospital
Prague, Czechia
Actively Recruiting
7
General University Hospital in Prague - FVN
Prague, Czechia
Actively Recruiting
8
Institute of Clinical and Experimental Medicine - IKEM
Prague, Czechia
Actively Recruiting
9
University Hospital Avicenne AP-HP
Bobigny, France
Actively Recruiting
10
Département d'anesthésie-réanimation
Dijon, France, 21000
Not Yet Recruiting
11
University Hospital Lille - Institut Cœur Poumon
Lille, France
Actively Recruiting
12
University Hospital - Dupuytren Limoges
Limoges, France
Actively Recruiting
13
Regional University Hospital Nancy - Hopitaux de Brabois
Nancy, France
Actively Recruiting
14
Hôpital Pitié Salpêtrière
Paris, France, 75651
Not Yet Recruiting
15
Lariboisière Hospital AP-HP
Paris, France
Actively Recruiting
16
Radboud University Medical Center
Nijmegen, Netherlands
Actively Recruiting
17
Uniersytecki Szpital Kliniczny w Białystoku
Bialystok, Poland
Actively Recruiting
18
Górnośląskie Centrum Medyczne w Katowicach / Śląski Uniwersytet Medyczny w Katowicach
Katowice, Poland
Actively Recruiting
19
Clinical University Hospital Poznań
Poznan, Poland
Actively Recruiting
20
J. Mikulicz Radecki Clinical University Hospital Wrocław
Wroclaw, Poland
Actively Recruiting
Research Team
K
Karakas Mahir, Prof. Dr. Dr.
CONTACT
G
Gad Cotter, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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