Status and phase
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About
This is a Phase I/IIa open, uncontrolled, prospective study, to be conducted in an out-patient setting. The present study is one of two clinical trials of the RNActive®-derived vaccine CV9103 being conducted concurrently in the US and Europe, which represent the first clinical trials conducted for this novel vaccine.
The Phase I part of the study consists of a staggered inclusion of subjects in two cohorts of 3, to confirm the safety of the intended dose (320 µg RNA per antigen), with a lower dose to be considered in case of dose-limiting toxicity (DLT) being reported in greater than or equal to 2 out of 3-6 subjects; in this way, the recommended dose (RD) for the Phase IIa part of the study will be established. In the Phase IIa part of the study, additional subjects will be included at the RD, to confirm the safety and explore the activity of that dose.
Full description
Medical Need:
At present, no curative therapy is available for subjects with advanced or metastatic prostate cancer. Approximately 1 of every 3 men present with advanced or metastatic disease; therefore, current standard therapies are ineffective and new therapeutic approaches are warranted. There is ample evidence that active immunotherapy against cancer is safe and capable of stimulating potentially therapeutic immune responses in the cancer patient. Moreover, several Phase II immunotherapy trials have suggested clinical benefit by reducing the tumor mass or prolonging time to progression in subjects with advanced prostate cancer.
Potential Benefits:
CV9103 is an mRNA-based vaccine for the treatment of human prostate cancer that is based on CureVac's RNActive® technology. CV9103 encodes for 4 prostate specific antigens. Because these antigens are present in prostate cancer cells, they are appropriate targets for intervention. These antigens have been shown to correlate frequently with the progression of prostate cancer, and are known to be immunogenic in humans, where they induce antigen specific T-cell or B cell expansion.
As an RNA-based vaccine, CV9103 features several advantages over other approaches: it is highly specific, there is no restriction to the patient's MHC genotype, and it does not need to cross the nuclear membrane to be active. Finally, in the absence of reverse transcriptase, RNA can not be integrated into the genome.
CV9103 will be administered in 5 doses.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Subjects with documented history of hormone refractory prostate cancer as evidenced by three consecutive increases in serum PSA despite continued androgen ablative therapy. Serum testosterone levels must be less than 50 ng/dl
Signed informed consent in accordance with Good Clinical Practice (GCP) and local regulatory requirements prior to trial participation
Age greater than or equal to 18 yrs (Phase I and IIa) and less than or equal to 75 yrs (Phase IIa only)
ECOG (Eastern Cooperative Oncology Group) Grade of 0 or 1
Adequate Hematologic Function with:
Adequate Renal and Hepatic Function with:
Adequate Coagulation Parameters with:
Subjects will be advised to use barrier contraception while enrolled in the study and for one month after the last immunization.
Life Expectancy > 6 month
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
6 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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