| NCT ID | NCT07657806 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Hangzhou DAC Biotechnology Co., Ltd. |
| Condition | Advanced Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2026-08-19 |
| Primary Completion | 2029-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 110 participants in total. It began in 2026-08-19 with a primary completion date of 2029-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07657806 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Advanced Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07657806 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07657806 currently recruiting?
Yes, NCT07657806 is actively recruiting participants. Contact the research team at Shipengyu@dacbiotech.com for enrollment information.
Where is the NCT07657806 trial being conducted?
This trial is being conducted at Beijing, China, Suzhou, China, Chengdu, China, Chengdu, China and 3 additional locations.
Who is sponsoring the NCT07657806 clinical trial?
NCT07657806 is sponsored by Hangzhou DAC Biotechnology Co., Ltd.. The trial plans to enroll 110 participants.
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