OncoMatch/Clinical Trials/NCT04104607
The Bispecific PSMAxCD3 Antibody CC-1 in Patients with Castration Resistant Prostate Carcinoma
Is NCT04104607 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
Cancer type
Prostate Cancer
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
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.
Frequently asked questions
Is NCT04104607 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic chemotherapy or radiotherapy, investigational anticancer therapy disqualifies patients from enrollment.
Is this trial open to female patients?
No. This trial enrolls male patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages