DEC003M in Prostate Cancer

NCT07657806 | Not Yet Recruiting Phase 1

• 1 other identifier: DEC003M-001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 4

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.

Conditions

Advanced Prostate Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• 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

Study Arms (1)

Experimental

EXPERIMENTAL

DEC003M-001

Drug: DEC003M

Interventions

DEC003M DRUG

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

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At the time of informed consent, be ≥18 years of age.
• Histologically confirmed adenocarcinoma of the prostate.
• Metastatic castration-resistant prostate cancer (mCRPC) with documented disease progression despite androgen deprivation therapy.
• Prior orchiectomy or medical castration, or continuous treatment with luteinizing hormone releasing hormone analogues (LHRHa) .
• Measurable disease prior to enrollment.
• Testosterone at castration level.
• Progressed on standard therapy, or intolerant to standard therapy, or ineligible for standard therapy, or no standard therapy available.
• At least 1 prior Androgen Receptor Pathway Inhibitor.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

You may not qualify if:

• History of other malignancies.
• Inadequate organ function.
• Active autoimmune disease.
• Active CNS involvement.
• Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases.
• Any prior medical history of ILD/pneumonitis.
• Clinically significant corneal disorder or known severe dry eye.
• Grade 2 or higher peripheral neuropathy.
• Inadequate washout period for prior anticancer treatment.
• Any known history of or suspicion for history of clinically significant liver disease .
• Known hypersensitivity to any component of the DEC003M.
• Prior treatment with a PSMA-targeted antibody therapy.
• Other conditions judged by the investigator that may have effects on the patient's participation in the study.

Sponsors & Collaborators

• Hangzhou DAC Biotechnology Co., Ltd.: lead

Study Sites (4)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China

Location

The Third People's Hospital of Chengdu

Chengdu, Sichuan, 610095, China

Location

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 311121, China

Location

Chongqing University Cancer Hospital

Chongqing, 400030, China

Location

Central Study Contacts

Pengyu Shi

CONTACT

86-0571-56050590; Shipengyu@dacbiotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2026
• First Posted: June 18, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): May 1, 2031
• Last Updated: June 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)