The Bispecific PSMAxCD3 Antibody CC-1 in Patients with Castration Resistant Prostate Carcinoma

First in Human Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Bispecific PSMAxCD3 Antibody CC-1 in Patients with Castration Resistant Prostate Carcinoma

The Bispecific PSMAxCD3 Antibody CC-1 in Patients with Castration Resistant Prostate Carcinoma (NCT04104607) is a Phase 1 interventional studying Castration-Resistant Prostatic Cancer, sponsored by University Hospital Tuebingen. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Castration-Resistant Prostatic Cancer, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 86 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Castration-Resistant Prostatic Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: Patients with CRPC will be included in this clinical trial. Patients must meet all of the following inclusion criteria to be eligible for enrolment into the study: - Existence of a written willing to sign a consent form - Patient is able to understand and comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations - CRPC after third line therapy - Life expectance of \> 3 months - At least one measurable lesion that can be accurately assessed at baseline by CT or MRI and is suitable for repeated assessment - Eastern Cooperative Oncology Group Performance (ECOG) Status ≤ 2 - Patient aged ≥ 18, no upper age limit - Male patients with partners of child-bearing potential, who are sexually active, must agree to the use of two highly effective forms of contraception. This should be started from the signing of the willing to sign a consent form and continue throughout period of taking study treatment for 3 months after last dose of study drug. - Adequate bone marrow, renal, and hepatic function defined by laboratory tests within 14 days prior to study treatment: - blood count (hemoglobin) at least 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 kidney function (creatinine clearance) at least 60 ml/min Who Should NOT Join This Trial: Patients fulfilling any of the following criteria cannot be enrolled in the trial: - Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer - Concurrent or previous treatment within 30 days in another interventional clinical trial with an investigational anticancer therapy ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: Patients with CRPC will be included in this clinical trial. Patients must meet all of the following inclusion criteria to be eligible for enrolment into the study: * Existence of a written informed consent * Patient is able to understand and comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations * CRPC after third line therapy * Life expectance of \> 3 months * At least one measurable lesion that can be accurately assessed at baseline by CT or MRI and is suitable for repeated assessment * Eastern Cooperative Oncology Group Performance (ECOG) Status ≤ 2 * Patient aged ≥ 18, no upper age limit * Male patients with partners of child-bearing potential, who are sexually active, must agree to the use of two highly effective forms of contraception. This should be started from the signing of the informed consent and continue throughout period of taking study treatment for 3 months after last dose of study drug. * 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 Exclusion Criteria: Patients fulfilling any of the following criteria cannot be enrolled in the trial: * Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer * Concurrent or previous treatment within 30 days in another interventional clinical trial with an investigational anticancer therapy * Persistent toxicity (≥Grade 2 according to Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) caused by previous cancer therapy, excluding alopecia and neurotoxicity (≤ 2 grade) * Clinical signs of active infection (\>Grade 2 according to CTCAE version 5.0) * History of HIV infection * Immunocompromised patients * Active or chronic viral hepatitis (HBV or HCV) * History of autoimmune disease * History of relevant CNS pathology or current relevant CNS pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder) Epilepsy requiring pharmacologic treatment * Therapeutic anticoagulation therapy * Major surgery within 4 weeks of starting study treatment. Patients must have recovered from any effects of major surgery. * 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 * Heart failure NYHA III/IV * Severe obstructive or restrictive ventilation disorder * Known history of GI-perforation * Pre-existing HAHA * Known intolerance to CC-1, tocilizumab or other immunoglobulin drug products as well as hypersensitivity to any of the excipients present in the respective drug products (CC-1, tocilizumab)

Treatments Being Tested

DRUG

CC-1, PSMAxCD3

Infusion of CC-1 over 24 hours for 7 days with possible intra-patient dose-escalation

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

University Hospital Tuebingen

Tübingen, Baden-Wurttemberg, Germany

University hospital Heidelberg

Heidelberg, BadenWuerttemberg, Germany

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04104607), the sponsor (University Hospital Tuebingen), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04104607 clinical trial studying?

Who can participate in NCT04104607?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04104607?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04104607. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04104607. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.