Antibody CC-1 in Men With Biochemical Recurrence of Prostate Cancer

Launched by UNIVERSITY HOSPITAL TUEBINGEN · Dec 1, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CC-1 for men who have had a recurrence of prostate cancer after their initial treatment. Specifically, it looks at how safe the drug is and how well it works. CC-1 is designed to target prostate cancer cells while also reducing potential side effects. The study will start by testing lower doses to figure out the highest dose that can be safely given. If you are a man aged 18 or older with a history of prostate cancer and have experienced a biochemical recurrence, you might be eligible to participate, provided you meet certain health criteria.

If you join the trial, you will receive the CC-1 treatment through an intravenous infusion twice a week for three weeks, with some initial safety checks. Throughout the study, you will have regular check-ins and tests to monitor your health and the drug’s effects. This research aims to determine the best dosage for future studies, helping to improve treatment options for men facing similar health challenges. Remember, before enrolling, you'll need to give your written consent and ensure that you understand the study process.

Gender

MALE

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

Trial Officials