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NCT07657806From ClinicalTrials.govRecruiting

DEC003M in Prostate Cancer

A Phase 1 Study of DEC003M, an Antibody Drug Conjugate Targeting PSMA, for Advanced Stage Prostate Cancer

  • Advanced Prostate Cancer

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Hangzhou DAC Biotechnology Co., Ltd.
Enrolment target
110
Started
19 August 2026
Main results due
31 March 2029
Study sites
4
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Men only.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(4)

  • 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

  • Chongqing University Cancer Hospital

    Chongqing, China

    Recruiting

Showing 4 of 4 sites. 4 of the 4 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07657806. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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DEC003M in Prostate Cancer | Trialion