DEC003M in Prostate Cancer

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

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 Overview

• Status: Not yet recruiting
• Conditions: Advanced Prostate Cancer
• Intervention / Treatment: Drug: DEC003M

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Pengyu Shi; Phone Number: 86-0571-56050590; Email: Shipengyu@dacbiotech.com

Study Locations

• China
  • Chongqing, China, 400030
    • Chongqing University Cancer Hospital
    • Contact: Junyong Dai, MD (Doctor of Medicine); Phone Number: 86-18623251528; Email: daijunyong_cz@163.com
  • Sichuan
    • Chengdu, Sichuan, China, 610044
      • West China Hospital of Sichuan University
      • Contact: Qiang Wei, MD (Doctor of Medicine); Phone Number: 86-18980601425; Email: weiqianghx2022@163.com
      • Contact: Ping Feng, MD (Doctor of Medicine); Phone Number: 86-18980606320; Email: 617130961@qq.com
    • Chengdu, Sichuan, China, 610095
      • The Third People's Hospital of Chengdu
      • Contact: Hui Zhuo, MD (Doctor of Medicine); Phone Number: 86-13882150383; Email: 439574333@qq.com
  • Zhejiang
    • Hangzhou, Zhejiang, China, 311121
      • The First Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: Dan Xia, MD (Doctor of Medicine); Phone Number: 86-13336095637; Email: xiaxy1998@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; DEC003M-001	Drug: DEC003M; Once every 3 weeks (Q3W) with a cycle length of 21 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate（ORR）	Up to 24 months
PSA response rate	Up to 24 months
Radiographic Progression-Free Survival (rPFS)	Up to 24 months
overall survival (OS)	Up to 36 months

Collaborators and Investigators

• Sponsor: Hangzhou DAC Biotechnology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): May 1, 2031

Study Registration Dates

• First Submitted: June 15, 2026
• First Submitted That Met QC Criteria: June 15, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: DEC003M-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No