NCT07657806RecruitingPhase 1
DEC003M in Prostate Cancer
A Phase 1 Study of DEC003M, an Antibody Drug Conjugate Targeting PSMA, for Advanced Stage Prostate Cancer
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 15 Jun 2026
- Start date
- 19 Aug 2026
- Primary completion date
- 31 Mar 2029
- Lead sponsor
- Hangzhou DAC Biotechnology Co., Ltd.
- Diseases
- Prostate cancer
- NCT number
- NCT07657806
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 110
- From 19 Aug 2026 to the primary completion date, 31 Mar 2029
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any prior medical history of ILD/pneumonitis.
- Inadequate washout period for prior anticancer treatment.
- Prior treatment with a PSMA-targeted antibody therapy.
Other illness
- 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.
Other
- Inadequate organ function.
- Active CNS involvement.
- Grade 2 or higher peripheral neuropathy.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University First Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| The Third People's Hospital of Chengdu Coordinator of this site? Confirm its status | Chengdu | China | Recruiting |
| Chongqing University Cancer Hospital Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
| The First Affiliated Hospital of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
| The Second Affiliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Recruiting |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.