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Smart missile drug takes aim at Hard-to-Treat prostate cancer

NCT ID NCT07657806

Disease control Sponsor: Hangzhou DAC Biotechnology Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called DEC003M, which is designed to seek out and destroy prostate cancer cells by targeting a protein called PSMA. The trial enrolls adults with advanced prostate cancer that has stopped responding to standard hormone therapy. Researchers aim to find the safest dose and check whether the drug can shrink tumors or slow the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DEC003M (an antibody drug conjugate targeting PSMA)
What this could lead to
If successful, this could lead to a new treatment option for advanced prostate cancer that has stopped responding to hormone therapy.
What could go wrong
This is an early phase 1 trial with a small number of participants, so the drug may not prove effective or may have unexpected side effects. It is too early to know if it will benefit patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

May 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma prostate cancer prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced prostate cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chongqing University Cancer Hospital

    Chongqing, 400030, China

  • The First Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 311121, China

  • The Third People's Hospital of Chengdu

    Chengdu, Sichuan, 610095, China

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610044, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.