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 groupLocations
4The Third People's Hospital of Chengdu610095, ChengduSichuan, China
West China Hospital of Sichuan University610044, ChengduSichuan, China
The First Affiliated Hospital of Zhejiang University School of Medicine311121, HangzhouZhejiang, China
Chongqing University Cancer Hospital400030, Chongqing China
Sponsors and collaborators
Hangzhou DAC Biotechnology Co., Ltd.
Lead sponsor
Source ClinicalTrials.gov