Antibody CC-1 in Men With Biochemical Recurrence of Prostate Cancer
ConditionProstate Cancer Recurrent
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorUniversity Hospital Tuebingen
About this trial
This trial is a phase I open-label, single center study designed to evaluate the safety, tolerability and preliminary efficacy of the bispecific prostate specific membrane antigen (PSMA) and cluster of differentiation protein 3 (CD3) antibody CC-1 in men with biochemical recurrence (BCR) of prostate cancer (PC). The PSMA binder in CC-1 reacts with tumor cells and also binds to tumor vessels, 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 accordingly reduced side effects. The study entails a part I (dose escalation part) to identify the maximally tolerated dose of CC-1, which then will be further evaluated in part II of the study (dose expansion part). After application of two low doses as safety steps in the first cycle, CC-1 will be applied twice weekly for three consecutive weeks within 4 week cycles as a short-term intravenous infusion (3 hours). The planned trial ultimately shall define the recommended phase II dose (RP2D) of CC-1 in the disease setting of BCR of PC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
PSA >5 ng/ml.
PSA-DT < 1 year or
pathological ISUP grade 4-5
Interval to biochemical recurrence < 18 months or
Trial design
Design model
Sequential
Treatments tested in this trial
CC-1 Infusion
DrugShort term (3h) infusion of CC-1
Treatment groups
56 Participants
are divided into 2 treatment groupsGroup A: Dose Escalation PartExperimental treatment 1 intervention
Group B: Dose Expansion PartExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose escalation part: To define the maximum tolerated dose (MTD) of CC-1 as 3 hours infusion
Data Safety and Monitoring Board (DSMB) and Sponsor meeting about determination of the MTD for each cohort and the dose expansion phase
Time frame
during the procedure2
Dose expansion part: To define the recommended phase-II dose of CC-1
Data Safety and Monitoring Board and Sponsor meeting about determination of the recommended phase II dose of CC-1 for potential phase II trials.
Time frame
up to 1 month after procedureSecondary outcomes
1
To evaluate safety and tolerability of CC-1
Number of participants with Adverse Events (AEs) and with abnormal laboratory test results
Time frame
during the procedure2
To assess efficacy in terms of Prostata-Specific-Antigen (PSA) response and no PSA progression after CC-1 treatment
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
Time frame
during the procedure and through study completion, an average of 6 months3
To assess clinical outcome in terms of progression-free survival, treatment-free survival, overall survival
Overall and progression free survival status as percentage of patients alive at EOSf and each follow-up assessment
Time frame
through study completion, an average of 6 months4
To assess CC-1 serum concentrations
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).
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).Other outcomes
1
To identify predictive biomarkers of response and resistance
Samples for human anti-human antibody (HAHA) analysis
Time frame
during the procedure2
To evaluate pharmacokinetics and pharmacodynamics of CC-1 using Cytokine levels
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.
Time frame
baseline and immediately after procedureSponsors and contacts
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Source ClinicalTrials.gov