DEC003M in Prostate Cancer

Starting soon · Phase 1

Conditions studied: Advanced Prostate Cancer

In brief

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.

Key facts

Study ID

NCT07657806

Run by

Hangzhou DAC Biotechnology Co., Ltd.

People needed

110

Starts

2026-08-01

Expected to finish

2031-05-01

Last updated by the study team

2026-06-22

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• West China Hospital of Sichuan University — Chengdu, Sichuan, China
• The Third People's Hospital of Chengdu — Chengdu, Sichuan, China
• The First Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
• Chongqing University Cancer Hospital — Chongqing, China

Full record on ClinicalTrials.gov

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