Advanced Prostate CancerPhase 1NCT07657806
DEC003M in Prostate Cancer
A Phase 1 study testing DEC003M in people with Advanced Prostate Cancer, run by Hangzhou DAC Biotechnology Co., Ltd. at 7 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Advanced Prostate Cancer
- What is being tested?
- DEC003M
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 7 sitesChina
- Study dates
- 19 Aug 2026to 1 May 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Yu Fan, MD (Doctor of Medicine), 86-010-83572211, dantefanbmu@126.com
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan, 610044
Qiang Wei, MD (Doctor of Medicine), 86-18980601425, weiqianghx2022@163.com
Ping Feng, MD (Doctor of Medicine), 86-18980606320, 617130961@qq.com
- Recruiting
The Third People's Hospital of Chengdu
Chengdu, Sichuan, 610095
Hui Zhuo, MD (Doctor of Medicine), 86-13882150383, 439574333@qq.com
- Recruiting
Chongqing University Cancer Hospital
Chongqing, 400030
Junyong Dai, MD (Doctor of Medicine), 86-18623251528, daijunyong_cz@163.com
- Recruiting
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 311121
Dan Xia, MD (Doctor of Medicine), 86-13336095637, xiaxy1998@163.com
- Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
Boxin Xue, MD (Doctor of Medicine), 86-0512-68284303, 18994392817@163.com
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Wei Chen, MD (Doctor of Medicine), 86-0577-55578100, cw20220101@126.com
About this study
Official title: 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.
- Conditions
- Advanced Prostate Cancer
- Being tested
- DEC003M
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEC003MDrug
Once every 3 weeks (Q3W) with a cycle length of 21 days
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | DEC003M-001 Receives: Drug: DEC003M |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event
Measured: Screening up to study completion, an average of 1 year.
Dose-limiting toxicity (DLT)
Measured: 3 weeks
Recommended Dose for Expansion (RDE)
Measured: Up to 24 months
Secondary outcomes (4)
Objective Response Rate（ORR）
Measured: Up to 24 months
PSA response rate
Measured: Up to 24 months
Radiographic Progression-Free Survival (rPFS)
Measured: Up to 24 months
overall survival (OS)
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start19 Aug 2026
- Primary completion31 Mar 2029 (estimated)
- Study completion1 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou DAC Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07657806
- Sponsor's protocol ID
- DEC003M-001
- Status last verified
- Aug 2026
- First submitted
- 15 Jun 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of DEC003M, an Antibody Drug Conjugate Targeting PSMA, for Advanced Stage Prostate Cancer
- ClinicalTrials.gov ID
- NCT07657806
- Acronym / sponsor ID
- DEC003M-001
- Conditions
- Advanced Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Hangzhou DAC Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Aug 2026 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 1 May 2031 (estimated)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: DEC003MDEC003M-001 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- History of other malignancies.
- Inadequate organ function.
- Active autoimmune disease.
- Active CNS involvement.
- Uncontrolled or clinically significant cardiovascular and cerebrovascular diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DEC003MOnce every 3 weeks (Q3W) with a cycle length of 21 days | Drug | Experimental |
Primary outcome
Adverse event
Time frame: Screening up to study completion, an average of 1 year.
Dose-limiting toxicity (DLT)
Time frame: 3 weeks
Recommended Dose for Expansion (RDE)
Time frame: Up to 24 months
4 secondary outcomes
Objective Response Rate（ORR）
Time frame: Up to 24 months
PSA response rate
Time frame: Up to 24 months
Radiographic Progression-Free Survival (rPFS)
Time frame: Up to 24 months
overall survival (OS)
Time frame: Up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DEC003M in people with Advanced Prostate Cancer, run by Hangzhou DAC Biotechnology Co., Ltd. at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pengyu Shi (86-0571-56050590, Shipengyu@dacbiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event (time frame: Screening up to study completion, an average of 1 year.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.