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
- Conditions
- biochemical recurrence after curativelyintended therapy for localized PC
- Registration Number
- DRKS00031816
- Lead Sponsor
- niversitätsklinikum Tübingen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 38
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
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-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)
-ALT and AST = 2.5 x ULN
-?-GT = 2.5 x ULN
-PT-INR/PTT = 1.5 x ULN
-Creatine kinase = 2.5 x ULN
-Serum creatinine = 1.5 mg/dl or creatinine clearance = 60 ml/min
-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 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 CNS 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 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 & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Dose escalation part: To define the maximum tolerated dose (MTD) of CC-1 as 3 hours infusion<br><br>-Dose expansion part: To define the recommended phase-II dose of CC-1
- Secondary Outcome Measures
Name Time Method -To evaluate safety and tolerability of CC-1<br><br>-To assess efficacy in terms of PSA response and no PSA progression after CC-1 treatment<br><br>-To assess clinical outcome in terms of progressionfree survival, treatment-free survival, overall survival<br><br>-To assess pharmacokinetics of CC-1<br><br>-To assess quality of life