patients with hormone-refractory prostate cancer (HRPC) with rising PSA MedDRA version: 9.1 Level: LLT Classification code 10062904 Term: Hormone-refractory prostate cancer
Conditions
Interventions
Product Name: CV9103
Product Code: CV9103
Pharmaceutical Form: Solution for injection
Current Sponsor code: CV9103-1
Other descriptive name: encodes prostate specific antigen PSMA (FOLH1)
Concentrati
Sponsors
CureVac GmbH
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Signed informed consent in accordance with GCP and local regulatory requirements prior to trial participation 2. Male and age = 18 yrs (Phase I and II) and = 75 yrs (Phase II only) 3. Histologically confirmed diagnosis of adenocarcinoma of the prostate, Gleason Score available 4. Patients must have been treated with hormonal therapy and may have been treated with surgery and/ or radiation therapy 5. Progressive disease as defined by hormone-refractoriness and rise in PSA: Hormone refractoriness: Defined by a rise in PSA and/or RECIST-based progression of evaluable lesions, and/or increased number of hotspots on a bone scan, while the patient has a castrated level of testosterone. This castrated level may have been obtained by orchiectomy, or LH-RH analog ± antiandrogen. Antiandrogen must be discontinued for at least 4 weeks before study entry to exclude a withdrawal effect. Rise in PSA: Defined by a rise in PSA levels at three consecutive time points (PSA rise over nadir, separated by > 1 week, PCWG2 criteria) 6. Presence of metastatic disease is acceptable 7. ECOG performance status of 0 to 1 8. Life expectancy > 12 months as assessed by the investigator 9. Adequate organ function • Bone marrow function: Hemoglobin = 10 g/ dL; Leukocytes = 3000/ µL; Lymphocytes = 1000/ µL; Absolute neutrophil count = 1500/ µL; Platelet count = 100000/ µL • Hepatic: AST and ALT = 2.5 times upper limit of normal (ULN); Bilirubin = 1.5 ULN • Renal: Creatinine = 1.5 mg/ dL or creatinine clearance = 60mL/ min 10. Concomitant LH-RH therapy continuation is acceptable11. May have had local palliative radiotherapy for bone metastasis involving less than 25% of bone marrow 12. Patients requiring bisphosphonates at the time of registration into the trial are eligible (therapy initiated at least 28 days prior to first study treatment administration) and must be continued at a constant level during the study period 13. Patients of child-producing potential must agree to use contraception while enrolled in the study and for one month after the last immunization. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: The following are criteria for exclusion of patients from participating in the study: 1. Other histologic type of prostate cancer (transitional cell, small cell or squamous cell cancer) 2. Symptomatic brain metastasis or leptomeningeal involvement 3. Patients having received or currently receiving chemo- or biological therapy for prostate cancer 4. Symptomatic congestive heart failure (NYHA 3 and 4); unstable angina pectoris; significant cardiac arrhythmia 5. Pulmonary disease causing dyspnea or fatigue during normal activity 6. History of seizures, encephalitis or multiple sclerosis 7. Inflammatory bowel disease e.g. Crohn’s disease or ulcerative colitis; active diverticulitis 8. Documented history of active autoimmune disorders requiring systemic immunosuppressive therapy, (e.g. sarcoidosis, lupus erythematosus, rheumatoid arthritis, glomerulonephritis or systemic vasculitis), excepting autoimmune thyroiditis with only thyroid hormone replacement and stable disease > 1 year 9. Primary or secondary immune deficiency 10. History of allergy requiring medication 11. Active drug abuse or chronic alcoholism 12. Clinically significant active infections 13. Seropositive for HIV, HBV or HCV 14. History of other malignancies over the last 5 years (except basal cell carcinoma of the skin) 15. Uncontrolled medical condition considered as high risk for the treatment with an investigational drug including unstable diabetes mellitus, vena-cavasyndrome, known ascites and/or pleural effusion, symptomatic pleural effusion treated by puncture 16. Renal insufficiency requiring dialysis 17. Patients being committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I part: Determination of the recommended dose (RD) for exploration in the phase II part Phase II part: Assessment of safety of the trial regimen;Secondary Objective: Phase I part: Assessment of safety of the trial regimen Evaluation of induction of immune response Phase II part: Evaluation of induction of immune response Assessment of anti-tumor activity;Primary end point(s): Phase I part: Primary endpoint: occurrence of DLT before the week 5 visit in patients evaluablefor determination of RD Phase II part: Primary safety endpoints: • incidence and severity of adverse events and laboratory abnormalities, graded according to NCI-CTCAE version 3.0 criteria • occurrence of Serious Adverse Events • occurrence of treatment discontinuation due to adverse events • incidence of treatment emergent autoimmune disease or development of autoimmune antibodies | — |
Countries
Germany
Outcome results
None listed