DEC003M in Prostate Cancer
ConditionAdvanced Prostate Cancer
Trial statusRecruiting
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
DEC003M
DrugOnce every 3 weeks (Q3W) with a cycle length of 21 days
Treatment groups
110 Participants
are divided into 1 treatment groupGroup A: ExperimentalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Adverse event
Time frame
Screening up to study completion, an average of 1 year.2
Dose-limiting toxicity (DLT)
Time frame
3 weeks3
Recommended Dose for Expansion (RDE)
Time frame
Up to 24 monthsSecondary outcomes
1
Objective Response Rate（ORR）
Time frame
Up to 24 months2
PSA response rate
Time frame
Up to 24 months3
Radiographic Progression-Free Survival (rPFS)
Time frame
Up to 24 months4
overall survival (OS)
Time frame
Up to 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov