- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05646550
Antibody CC-1 in Men With Biochemical Recurrence of Prostate Cancer (ProSperACC-1)
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
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Jonas Heitmann, Dr.
- Phone Number: 82844 +49(0)707129
- Email: jonas.heitmann@med.uni-tuebingen.de
Study Contact Backup
- Name: Walz
- Phone Number: 83275 +49(0)707129
- Email: kketi@med.uni-tuebingen.de
Study Locations
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Tuebingen, Germany, 72076
- Recruiting
- University Hospital Tuebingen
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Contact:
- Helmut Salih, Prof. Dr.
- Phone Number: 83275 +49(0)707129
- Email: KKETI@med.uni-tuebingen.de
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Principal Investigator:
- Walz, Prof. Dr
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Sub-Investigator:
- Heitmann, Dr.
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Contact:
- Phone Number: 85275 +49(0)707129
- Email: zks-pm@med.uni-tuebingen.de
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dose Escalation Part
In the dose escalation part, up to 7 dose cohorts will be included depending on occurrence of dose-limiting toxicity (DLT).
Each dose cohort has a predefined day 3 dose level (DL): cohort 1, 78µg; cohort 2, 110µg; cohort 3, 150µg; cohort 4, 210µg; cohort 5, 300µg; cohort 6, 400µg; cohort 7, 600µg.
Each dose cohort will consist of at least three patients evaluable for DLT.
Maximum tolerated dose (MTD) is defined on at least six patients
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Short term (3h) infusion of CC-1
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Experimental: Dose Expansion Part
CC-1 is administered as a 3-hour short-term intravenous infusion started at the MTD dose level identified in the dose escalation part of the study or based on the discretion of the sponsors delegate and DSMB recommendation supported by preliminary safety and efficacy data to constitute a modified MTD, e.g. to be one or more dose levels lower than the MTD determined.
Patients can be treated simultaneously during the dose expansion phase.
Patients must be hospitalized during step dosing, i.e. from day 1-4 (last dosing on day 3) of the first cycle.
Thereafter inpatient treatment (overnight stay) depends on the discretion of the investigator, an outpatient treatment is preferred.
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Short term (3h) infusion of CC-1
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose escalation part: To define the maximum tolerated dose (MTD) of CC-1 as 3 hours infusion
Time Frame: during the procedure
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Data Safety and Monitoring Board (DSMB) and Sponsor meeting about determination of the MTD for each cohort and the dose expansion phase
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during the procedure
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Dose expansion part: To define the recommended phase-II dose of CC-1
Time Frame: up to 1 month after procedure
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Data Safety and Monitoring Board and Sponsor meeting about determination of the recommended phase II dose of CC-1 for potential phase II trials.
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up to 1 month after procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate safety and tolerability of CC-1
Time Frame: during the procedure
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Number of participants with Adverse Events (AEs) and with abnormal laboratory test results
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during the procedure
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To assess CC-1 serum concentrations
Time Frame: during the procedure prior to and after start of infusion on each treatment day in the first cycle (each cycle is 28 days).
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CC-1 serum concentrations assessed prior to and after start of infusion on each treatment day in the first cycle (each cycle is 28 days).
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during the procedure prior to and after start of infusion on each treatment day in the first cycle (each cycle is 28 days).
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To assess quality of life
Time Frame: through study completion, an average of 1 year
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Quality of life is defined as overall quality of life scores European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ).
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through study completion, an average of 1 year
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To assess efficacy in terms of Prostata-Specific-Antigen (PSA) response and no PSA progression after CC-1 treatment
Time Frame: during the procedure and through study completion, an average of 6 months
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PSA response will be defined as ≥50% PSA decrease.
In addition, "No PSA doubling", defined as PSA measured at visits C1-6, End Of Treatment (EOT), End Of Safety follow up (EOSf) and Follow-up (FU)1-5 divided by PSA measured at baseline, will be assessed as further efficacy endpoint.
Furthermore, percentage of patients with no clinical relapse, no salvage and no subsequent antineoplastic therapy will be assessed
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during the procedure and through study completion, an average of 6 months
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To assess clinical outcome in terms of progression-free survival, treatment-free survival, overall survival
Time Frame: through study completion, an average of 6 months
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Overall and progression free survival status as percentage of patients alive at EOSf and each follow-up assessment
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through study completion, an average of 6 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To identify predictive biomarkers of response and resistance
Time Frame: during the procedure
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Samples for human anti-human antibody (HAHA) analysis
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during the procedure
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To evaluate pharmacokinetics and pharmacodynamics of CC-1 using Cytokine levels
Time Frame: baseline and immediately after procedure
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Cytokine levels in serum as assessed at baseline and after therapy using a commercially available, flow cytometry-based assay that allows parallel determination of different cytokines in one serum sample.
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baseline and immediately after procedure
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Walz, Prof. Dr., CCU Translational Immunology
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ProSperA_CC-1
- 2022-002420-13 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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