DRKS00031816
Recruiting
Phase 1
Phase I study to evaluate the safety, tolerability and preliminary efficacy of the bispecific PSMAxCD3 antibody CC-1 in men with biochemical recurrence of prostate cancer - ProSperA_CC-1
niversitätsklinikum Tübingen0 sites38 target enrollmentMay 12, 2023
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- biochemical recurrence after curativelyintended therapy for localized PC
- Sponsor
- niversitätsklinikum Tübingen
- Enrollment
- 38
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
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
- •\- Earlier histologic diagnosis of prostatic adenocarcinoma
- •\- Low risk of rapid disease progression, defined as:
- •\-PSA\-DT \> 1 year AND pathological ISUP grade \< 4 for men with prior radical prostatectomy
- •\-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\-PET imaging
Exclusion Criteria
- •\-PSA \>5 ng/ml.
- •\-For men with prior radical prostatectomy:
- •\-PSA\-DT \< 1 year
- •\- pathological ISUP grade 4\-5
- •\-For men with prior radiation therapy:
- •\- Interval to biochemical recurrence \< 18 months
- •\- 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.
Outcomes
Primary Outcomes
Not specified
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