DEC003M in Advanced Prostate Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label Phase 1 study of DEC003M for advanced prostate cancer. The trial uses a dose-escalation phase to find a suitable dose for expansion, followed by a dose-expansion phase to explore preliminary antitumor activity, safety, and how the drug behaves in the body. Eligible participants have metastatic castration-resistant prostate cancer with measurable disease and adequate organ function, and must have had at least one prior Androgen Receptor Pathway Inhibitor. Key exclusions include history of other malignancies and active autoimmune or CNS disease. The study is led by Hangzhou DAC Biotechnology with participating sites in Beijing, Suzhou, and Chengdu.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. At the time of informed consent, be ≥18 years of age.
2. Histologically confirmed adenocarcinoma of the prostate.
3. Metastatic castration-resistant prostate cancer (mCRPC) with documented disease progression despite androgen deprivation therapy.
4. Prior orchiectomy or medical castration, or continuous treatment with luteinizing hormone releasing hormone analogues (LHRHa) .
5. Measurable disease prior to enrollment.
6. Testosterone at castration level.
7. Progressed on standard therapy, or intolerant to standard therapy, or ineligible for standard therapy, or no standard therapy available.
8. At least 1 prior Androgen Receptor Pathway Inhibitor.
9. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

1. History of other malignancies.
2. Inadequate organ function.
3. Active autoimmune disease.
4. Active CNS involvement.
5. Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases.
6. Any prior medical history of ILD/pneumonitis.
7. Clinically significant corneal disorder or known severe dry eye.
8. Grade 2 or higher peripheral neuropathy.
9. Inadequate washout period for prior anticancer treatment.
10. Any known history of or suspicion for history of clinically significant liver disease .
11. Known hypersensitivity to any component of the DEC003M.
12. Prior treatment with a PSMA-targeted antibody therapy.
13. Other conditions judged by the investigator that may have effects on the patient's participation in the study.

Where it's running

• Peking University First Hospital
  Beijing, Beijing Municipality, China Recruiting
• The Second Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting
• West China Hospital of Sichuan University
  Chengdu, Sichuan, China Recruiting
• The Third People's Hospital of Chengdu
  Chengdu, Sichuan, China Recruiting
• The First Affiliated Hospital of Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting
• The First Affiliated Hospital of Wenzhou Medical University
  Wenzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Pengyu Shi
• Email: Shipengyu@dacbiotech.com
• Phone: 86-0571-56050590

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.