DEC003M in Prostate Cancer

ClinicalTrials.gov ID

NCT07657806

Lead Sponsor

Hangzhou DAC Biotechnology Co., Ltd.INDUSTRY

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 1

Enrollment

110Estimated

Last Update Posted

Jun 22, 2026Actual

Start Date

Aug 1, 2026Estimated

Primary Completion Date

Mar 31, 2029Estimated

Completion Date

May 1, 2031Estimated

Official Title

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

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.

• Advanced Prostate Cancer

• DEC003M

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Male

Accepts Healthy Volunteers

No

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.

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Hangzhou DAC Biotechnology Co., Ltd.INDUSTRY

439574333@qq.com86-13882150383

daijunyong_cz@163.com86-18623251528

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