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Recruiting Phase 1

DEC003M in Prostate Cancer

NCT07657806 · tracked via the Priya Life Science China tracker
Phase
Phase 1
Started
2026-08-19
Last updated
2026-10-14

Condition(s) studied

Advanced Prostate Cancer

Investigational drug(s) / intervention(s)

DEC003M

DEC003M: Once every 3 weeks (Q3W) with a cycle length of 21 days

Study summary

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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Adverse event — Screening up to study completion, an average of 1 year.
  • Dose-limiting toxicity (DLT) — 3 weeks
  • Recommended Dose for Expansion (RDE) — Up to 24 months

Trial sites (7)

FacilityCityRegionStatus
Peking University First Hospital Beijing Beijing Municipality Recruiting
The Second Affiliated Hospital of Soochow University Suzhou Jiangsu Recruiting
West China Hospital of Sichuan University Chengdu Sichuan Recruiting
The Third People's Hospital of Chengdu Chengdu Sichuan Recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting
The First Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang Recruiting
Chongqing University Cancer Hospital Chongqing China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07657806 on ClinicalTrials.gov ↗ ← All trials in China