Tests DEC003M, a targeted drug, in advanced prostate cancer
Tests DEC003M, a targeted drug, in adults with advanced prostate cancer.
Plain-language title generated from the registry record
Registry title: DEC003M in Prostate Cancer
Key facts
- Where
- Beijing, Chengdu, Chongqing, Hangzhou, Suzhou, and Wenzhou, ChinaSee the 7 sites
- Phase
- Phase 1
Where in China
- Peking University First HospitalBeijing, ChinaTaking people
- The Third People's Hospital of ChengduChengdu, ChinaTaking people
- West China Hospital of Sichuan UniversityChengdu, ChinaTaking people
- Chongqing University Cancer HospitalChongqing, ChinaTaking people
- The First Affiliated Hospital of Zhejiang University School of MedicineHangzhou, ChinaTaking people
- The Second Affiliated Hospital of Soochow UniversitySuzhou, ChinaTaking people
- The First Affiliated Hospital of Wenzhou Medical UniversityWenzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hangzhou DAC Biotechnology Co., Ltd.
- Trial code
- NCT07657806
- Record updated
- 14 October 2026
- Original description
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.Read full original descriptionShow less
A Phase 1 Study of DEC003M, an Antibody Drug Conjugate Targeting PSMA, for Advanced Stage Prostate Cancer
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.
Inclusion: 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: Any prior medical history of ILD/pneumonitis; Inadequate washout period for prior anticancer treatment; Prior treatment with a PSMA-targeted antibody therapy; History of other malignancies; Active autoimmune disease; Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases; Clinically significant corneal disorder or known severe dry eye; Any known history of or suspicion for history of clinically significant liver disease ; Known hypersensitivity to any component of the DEC003M; Other conditions judged by the investigator that may have effects on the patient's participation in the study; Inadequate organ function; Active CNS involvement; Grade 2 or higher peripheral neuropathy.