Using antibody CC-1 to treat men with recurrent prostate cancer

Phase I Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the Bispecific Antibody CC-1 in Men With Biochemical Recurrence of Prostate Cancer

This study is testing a new antibody treatment called CC-1 to see if it can safely help men with recurrent prostate cancer.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: University Hospital Tuebingen (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Tübingen)
• Trial ID: NCT05646550 on ClinicalTrials.gov

What this trial studies

This phase I open-label study evaluates the safety, tolerability, and preliminary efficacy of the bispecific antibody CC-1 in men experiencing biochemical recurrence of prostate cancer. The antibody targets prostate-specific membrane antigen (PSMA) and CD3, allowing for a dual anti-cancer action by binding to tumor cells and vessels. The trial includes a dose escalation phase to determine the maximum tolerated dose, followed by a dose expansion phase where CC-1 will be administered intravenously twice weekly for three weeks. The study aims to assess both the safety profile and potential effectiveness of this novel treatment approach.

Who should consider this trial

Good fit: Ideal candidates are men aged 18 and older with a prior diagnosis of prostate cancer who have experienced biochemical recurrence without distant metastasis.

Not a fit: Patients with aggressive disease progression or those with distant metastasis may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for men with recurrent prostate cancer, potentially improving outcomes and quality of life.

How similar studies have performed: While this approach is novel, similar studies targeting PSMA have shown promise in treating prostate cancer, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* 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
* Men aged 18 and above
* Earlier histologic diagnosis of prostatic adenocarcinoma
* Low risk of rapid disease progression, defined as:

  \- PSA-detection Time (DT) \> 1 year AND pathological International Society of Urological Pathology (ISUP) grade \< 4 for men with prior radical prostatectomy or Interval to biochemical recurrence \> 18 months and biopsy ISUP grade \< 4 for men with prior radiation therapy
* Biochemical recurrence (BCR) in compliance with the following 3 conditions:

  * after having finished last definitive treatment
  * PSA ≥0.2 ng/mL or PSA \> nadir + 2 ng/mL (after definitive RT), with two increasing PSA values prior to study treatment
  * no distant metastasis upon PSMA- positron emission tomography (PET) imaging
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
* Male patients with partners of child-bearing potential, who are sexually active, must agree to the use of one highly effective form of contraception and one barrier method. This should be started from the signing of the informed consent and continue throughout period of taking study treatment and for 4 months after the last dose of study drug
* Adequate bone marrow, renal, and hepatic function defined by laboratory tests within 21 days prior to study treatment:

  * Hemoglobin ≥ 9 g/dl (Transfusion of packed red blood cells prior to enrolment allowed)
  * Neutrophil count ≥ 1,500/mm3
  * Platelet count ≥ 100,000/µl
  * Bilirubin ≤ 1.5 x upper limit of normal (ULN)
  * alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN
  * gamma-glutamyl-transferase (γ-GT) ≤ 2.5 x ULN
  * prothrombin time (PT) - international normalised ratio (INR) / partial thromboplastin time (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:

* PSA \>5 ng/ml.
* For men with prior radical prostatectomy:

  * PSA-DT \< 1 year or
  * pathological ISUP grade 4-5
* For men with prior radiation therapy:

  * Interval to biochemical recurrence \< 18 months or
  * biopsy ISUP grade 4-5
* Other malignancy within the last 2 years except: adequately treated non-melanoma skin cancer and low-grade non-muscle invasive papillary bladder cancer.
* Concurrent or previous treatment within 30 days in another interventional clinical trial with an investigational anticancer therapy
* Patients who are receiving androgen-deprivation therapy.
* Patients who have received prior Androgen Deprivation Therapy (ADT) are not eligible with the exception of those that received ADT ≤ 36 months in duration and ≥9 months before enrolment and administered only in the neoadjuvant/adjuvant setting.
* Castrate level of serum testosterone \<50 ng/dL at screening.
* History of HIV infection
* Viral active or chronic hepatitis (HBV or HCV)
* Ongoing autoimmune disease
* Current relevant central nervous system 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)
* Therapeutic anticoagulation
* Non-controlled hypertension, defined as mean blood pressure values in 24-hours blood pressure measurement of \>130 mmHg or \>90 mmHg for systolic or diastolic, respectively
* Heart failure defined as New York Heart Association (NYHA) III/IV
* Severe obstructive or restrictive ventilation disorder
* Known intolerance to CC-1 or other immunoglobulin drug products as well as hypersensitivity to any of the excipients present in CC-1

Where this trial is running

Tübingen

• University Hospital Tuebingen — Tübingen, Germany (Recruiting)

Study contacts

• Principal investigator: Walz, Prof. Dr. — CCU Translational Immunology
• Study coordinator: Walz

Conditions Prostate Cancer Recurrent