DEC003M in Prostate Cancer
ConditionAdvanced Prostate Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18+
SponsorHangzhou DAC Biotechnology Co., Ltd.
About this trial
This is an open-label, multicenter Phase 1 study of DEC003M, in patients with advanced stage prostate cancer. The study consists of a dose-escalation phase to determine the dose for expansion, followed by a dose-expansion phase to evaluate preliminary antitumor activity, safety, and pharmacokinetics.
Eligibility criteria
Qualifiers
At the time of informed consent, be ≥18 years of age.
Histologically confirmed adenocarcinoma of the prostate.
Metastatic castration-resistant prostate cancer (mCRPC) with documented disease progression despite androgen deprivation therapy.
Prior orchiectomy or medical castration, or continuous treatment with luteinizing hormone releasing hormone analogues (LHRHa) .
Disqualifiers
History of other malignancies.
Inadequate organ function.
Active autoimmune disease.
Active CNS involvement.
Trial design
Treatments tested in this trial
- DEC003M
Treatment groups
110 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov