Tests invobenitug in adults with cardiogenic shock and raised DPP3 levels

Trial details

Who runs it

4TEEN4 Pharmaceuticals GmbH

Trial code

NCT06832722EU 2024-518450-16-00

Record updated

14 September 2026

Original 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.Read full original descriptionShow less

Multi-center, Randomized, Placebo-controlled, Double-blind Phase 1b/2a Trial to Investigate Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy of Invobenitug Also Known as Procizumab (PCZ; AK1967) in Patients With Cardiogenic Shock and Elevated Circulating Dipeptidyl Peptidase 3 (cDPP3) Concentrations.

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.

Inclusion: Signed informed consent; Diagnosis of CS based on the following entry criteria:; Need for ongoing vasopressors and/or inotropes to maintain a MAP ≥ 65 mmHg or SBP ≥ 90 mmHg; Lactate ≥ 2.0 mmol/L; High DPP3 concentration ≥ 30 ng/mL; Etiology of CS must be one of the following: ACS, septic (according to SEPSIS 3 criteria) or adHF origin.

Exclusion: Patients who will be receiving vasopressors and/or inotropes for more than 16 hours prior to receiving the IMP; Patients receiving Ang II and/or levosimendan; Reduced life expectancy of less than 6 months due to comorbidities (prior to shock onset); 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; Sustained SBP > 120 mmHg during the hour prior to randomization; 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; Patients who are currently enrolled in another clinical trial, or who have participated in such trials within one month prior to randomization; Patients with known allergies or hypersensitivity to the IMP or its excipients or any related medication; Stroke or transient ischemic attack within the last 3 months; Very severe frailty, or moribund condition or presence of clinical circumstances indicating imminent death; Primary hypertrophic or restrictive cardiomyopathy or congenital heart disease or systemic illness known to be associated with infiltrative heart disease; Patients with valvular heart diseases as the primary cause of cardiogenic shock; Other known causes of shock, namely; Hypovolemia; Hemorrhage; Anaphylaxis; Intoxication (e.g., drug-induced shock); Dynamic left ventricular outflow tract obstruction; isolated right heart failure, including cardiac tamponade and/or pulmonary embolism; Known mechanical complications due to myocardial infarction, including papillary muscle rupture, ventricular septal rupture, free wall rupture; Inappropriate pacing or shock resulting from ICD malfunction; 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; 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; Patients below the age of 18 or above 80 years; Patients being longer than 24 hours in the ICU at the time of randomization; SCAI Shock Stage E; Patients exceeding a maximum body weight of 120 kg (EU, Armenia, Serbia) and 150 kg (US); CPR lasting more than 15 minutes and/or the patient is not conscious at randomization; Pericardial constriction; Patients with untreated sepsis; Women who are pregnant or breastfeeding; Any reason that the investigator anticipates that the patient will be unable to complete the protocol or its required procedures (US only).

ClinicalTrials.gov NCT06832722 · EU CTIS 2024-518450-16-00