DEC003M in Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DEC003M.
- Who it may be relevant to
- Registry conditions: Advanced Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1 Study of DEC003M, an Antibody Drug Conjugate Targeting PSMA, for Advanced Stage Prostate Cancer
Overview
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.
Interventions
- Drug DEC003M
Once every 3 weeks (Q3W) with a cycle length of 21 days
Primary outcome measures
- Adverse event [Time frame: Screening up to study completion, an average of 1 year.]
- Dose-limiting toxicity (DLT) [Time frame: 3 weeks]
- Recommended Dose for Expansion (RDE) [Time frame: Up to 24 months]
Secondary outcome measures (4)
- Objective Response Rate（ORR） [Time frame: Up to 24 months]
- PSA response rate [Time frame: Up to 24 months]
- Radiographic Progression-Free Survival (rPFS) [Time frame: Up to 24 months]
- overall survival (OS) [Time frame: Up to 36 months]
Eligibility criteria
Inclusion criteria
- 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) .
- Measurable disease prior to enrollment.
- Testosterone at castration level.
- Progressed on standard therapy, or intolerant to standard therapy, or ineligible for standard therapy, or no standard therapy available.
- At least 1 prior Androgen Receptor Pathway Inhibitor.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion criteria
- History of other malignancies.
- Inadequate organ function.
- Active autoimmune disease.
- Active CNS involvement.
- Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases.
- Any prior medical history of ILD/pneumonitis.
- Clinically significant corneal disorder or known severe dry eye.
- Grade 2 or higher peripheral neuropathy.
- Inadequate washout period for prior anticancer treatment.
- Any known history of or suspicion for history of clinically significant liver disease .
- Known hypersensitivity to any component of the DEC003M.
- Prior treatment with a PSMA-targeted antibody therapy.
- Other conditions judged by the investigator that may have effects on the patient's participation in the study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 4 centers
- West China Hospital of Sichuan University — Chengdu
- The Third People's Hospital of Chengdu — Chengdu
- The First Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou
- Chongqing University Cancer Hospital — Chongqing
Identifiers
NCT: NCT07657806 · DEC003M-001