OncoMatch/Clinical Trials/NCT04104607
The Bispecific PSMAxCD3 Antibody CC-1 in Patients with Castration Resistant Prostate Carcinoma
Is NCT04104607 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CC-1, PSMAxCD3 for castration-resistant prostatic cancer.
Treatment: CC-1, PSMAxCD3 — This trial is a first in human (FIH) study in patients with castration resistant metastatic prostate cancer (CRPC) after failure of third-line therapy aiming to evaluate safety and efficacy of CC-1, a bispecific antibody (bsAb) with PSMAxCD3 specificity developed within DKTK. CC-1 binds to human prostate-specific membrane antigen (PSMA) on prostate cancer cells as well as to tumor vessels of CRPC, thereby allowing for a dual mode of anti-cancer action. CC-1 was developed in a novel format which not only prolongs serum half-life but most importantly reduces off-target T cell activation with expected fewer side effects. Together with preemptive IL-6 receptor (IL-6R) blockade using tocilizumab, this allows for application of effective bsAb doses with expected high anticancer activity. The study comprises two phases. The first phase is a doseescalation phase with concomitant prophylactic application of tocilizumab to evaluate the maximally tolerated dose (MTD) of CC-1. This is followed by a dose-expansion phase (also with prophylactic IL-6R blockade using tocilizumab), as this approach has been shown to be efficient and beneficial for patients. A translational research program comprising, among others, analysis of CC-1 half-life and the induced immune response as well as molecular profiling in liquid biopsies will serve to better define the mode of action of CC-1 and to identify biomarkers for further clinical development.
Check if I qualifyExtracted eligibility criteria
Cancer type
Prostate Cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: any anticancer therapy
CRPC after third line therapy
Cannot have received: systemic chemotherapy or radiotherapy
Patients receiving any systemic chemotherapy or radiotherapy within 2 weeks prior to study treatment or a longer period depending on the defined characteristics of the agents used
Cannot have received: investigational anticancer therapy
Concurrent or previous treatment within 30 days in another interventional clinical trial with an investigational anticancer therapy
Lab requirements
Blood counts
Hemoglobin ≥ 10 g/dl; Neutrophil count ≥ 1,500/mm3; Platelet count ≥ 100,000/μl; PT-INR/PTT ≤ 1.5 x ULN; Creatine kinase ≤ 2.5 x ULN
Kidney function
Serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 60 ml/min
Liver function
Bilirubin ≤ 1.5 x ULN; ALT and AST ≤ 2.5 x ULN; Alkaline phosphatase ≤ 2.5 x ULN
Adequate bone marrow, renal, and hepatic function defined by laboratory tests within 14 days prior to study treatment: * Hemoglobin ≥ 10 g/dl * Neutrophil count ≥ 1,500/mm3 * Platelet count ≥ 100,000/μl * Bilirubin ≤ 1.5 x upper limit of normal (ULN) * ALT and AST ≤ 2.5 x ULN * Alkaline phosphatase ≤ 2.5 x ULN * PT-INR/PTT ≤ 1.5 x ULN * Creatine kinase ≤ 2.5 x ULN * Serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 60 ml/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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