Metastatic Castration-resistant Prostate Cancer, mCRPCPhase 1NCT07537010
3D1015 Injection for Patients With mCRPC
A Phase 1 study testing Lu 177-PSMA-3D1015 Injection in people with Metastatic Castration-resistant Prostate Cancer, mCRPC, run by Chunjing Yu at 1 site in China.
Trial summary
This open-label clinical study investigates 3D1015 Injection (Lu 177-PSMA-3D1015) in adult males with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer, mCRPC
- What is being tested?
- Lu 177-PSMA-3D1015 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 27 Aug 2025to 31 Dec 2027
- 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
- Capable of understanding and providing written informed consent. Willing and able to comply with all study requirements, treatments, and scheduled visits.
- Male, aged 18 years or older.
- Histologically or cytologically confirmed prostate adenocarcinoma.
- Castrate levels of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L).
- Must be 68Ga-PSMA PET/CT scan positive.
- ECOG performance status of 0 to 2.
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- Confirmed progressive metastatic castration-resistant prostate cancer (mCRPC) that is refractory to or has progressed following prior treatments.
- Presence of at least one metastatic lesion at baseline.
- Adequate Organ Function.
- Resolution of all prior treatment-related toxicities to Grade ≤ 2 (excluding alopecia).
Who cannot join
- Receipt of other systemic anti-cancer therapies within 4 weeks prior to study entry.
- Life expectancy of < 6 months, as assessed by the investigator.
- A superscan as seen in the baseline bone scan.
- Presence of clinically significant, uncontrolled, or unstable concurrent medical conditions that may compromise patient safety or study assessments.
- Known hypersensitivity or severe intolerance to the study drug, its excipients, or structurally related compounds.
- Any medical, psychiatric, or logistical condition that, per investigator judgment, would preclude protocol compliance or compromise patient safety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jiangnan University Affiliated Hospital
Wuxi, Jiangsu
chunjing Yu
About this study
Official title: Safety, Dosimetry, and Preliminary Efficacy of 3D1015 Injection in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC): An Open-Label Clinical Study
This open-label clinical study investigates 3D1015 Injection (Lu 177-PSMA-3D1015) in adult males with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). Participants will receive intravenous infusions of 3D1015, with treatment regimens dynamically individualized to optimize patient safety and outcomes. The primary objectives are to assess the safety, tolerability, and dosimetry of the injection. Secondary objectives include evaluating preliminary anti-tumor efficacy and exploring the optimal dosing regimen.
- Being tested
- Lu 177-PSMA-3D1015 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu 177-PSMA-3D1015 InjectionDrug
3D1015 is administered intravenously at an individualized dose.
| Study group | Role | What they receive |
|---|---|---|
| Lu 177-PSMA-3D1015 | Experimental | Not described Receives: Drug: Lu 177-PSMA-3D1015 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
Safety and tolerability will be evaluated by monitoring the incidence and severity of TEAEs.
Measured: From first dose of study drug through end of treatment (~36-48 weeks)
Occurrence of Dose-Limiting Toxicities (DLTs)
Number of participants experiencing dose-limiting toxicities (DLTs) .
Measured: From first dose of study drug through end of treatment (~36-48 weeks)
Absorbed Dose
Absorbed dose to the whole body, critical organs (e.g., kidneys, salivary glands), and tumor lesions assessed via serial imaging data.
Measured: From first dose of study drug through end of treatment (~36-48 weeks)
Effective Half-Life
Effective half-life of the study drug in the whole body, major organs, and tumor lesions determined by serial imaging.
Measured: From first dose of study drug through end of treatment (~36-48 weeks)
Secondary outcomes (3)
The proportion of patients with a PSA change from baseline
The effect of Lu 177-PSMA-3D1015 on prostate-specific antigen (PSA) kinetics.
Measured: From first dose of study drug through end of treatment (~36-48 weeks)
Objective Response Rate (ORR)
Percentage of participants with a complete response (CR) or partial response (PR).
Measured: From first dose of study drug through efficacy follow-up period (Up to approximately 5 years)
Radiographic progression-free survival (rPFS)
rPFS per investigator assessment.
Measured: From first dose of study drug through efficacy follow-up period (Up to approximately 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start27 Aug 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate Cancer, mCRPCStudies 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
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chunjing Yu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chunjing Yu, Affiliated Hospital of Jiangnan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537010
- Sponsor's protocol ID
- 3D1015-CN-001
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Dosimetry, and Preliminary Efficacy of 3D1015 Injection in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC): An Open-Label Clinical Study
- ClinicalTrials.gov ID
- NCT07537010
- Acronym / sponsor ID
- 3D1015-CN-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Chunjing YuUniversity, hospital or other
- Study start
- 27 Aug 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Apr 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 open-label clinical study investigates 3D1015 Injection (Lu 177-PSMA-3D1015) in adult males with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). Participants will receive intravenous infusions of 3D1015, with treatment regimens dynamically individualized to optimize patient safety and outcomes. The primary objectives are to assess the safety, tolerability, and dosimetry of the injection. Secondary objectives include evaluating preliminary anti-tumor efficacy and exploring the optimal dosing regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lu 177-PSMA-3D1015 | Experimental | Drug: Lu 177-PSMA-3D1015 Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Capable of understanding and providing written informed consent. Willing and able to comply with all study requirements, treatments, and scheduled visits.
- Male, aged 18 years or older.
- Histologically or cytologically confirmed prostate adenocarcinoma.
- Castrate levels of serum/plasma testosterone (< 50 ng/dL or < 1.7 nmol/L).
- Must be 68Ga-PSMA PET/CT scan positive.
Key exclusion criteria (6 listed)
- Receipt of other systemic anti-cancer therapies within 4 weeks prior to study entry.
- Life expectancy of < 6 months, as assessed by the investigator.
- A superscan as seen in the baseline bone scan.
- Presence of clinically significant, uncontrolled, or unstable concurrent medical conditions that may compromise patient safety or study assessments.
- Known hypersensitivity or severe intolerance to the study drug, its excipients, or structurally related compounds.
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 |
|---|---|---|
| Lu 177-PSMA-3D1015 Injection3D1015 is administered intravenously at an individualized dose. | Drug | Lu 177-PSMA-3D1015 |
Primary outcome
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose of study drug through end of treatment (~36-48 weeks)
Safety and tolerability will be evaluated by monitoring the incidence and severity of TEAEs.
Occurrence of Dose-Limiting Toxicities (DLTs)
Time frame: From first dose of study drug through end of treatment (~36-48 weeks)
Number of participants experiencing dose-limiting toxicities (DLTs) .
Absorbed Dose
Time frame: From first dose of study drug through end of treatment (~36-48 weeks)
Absorbed dose to the whole body, critical organs (e.g., kidneys, salivary glands), and tumor lesions assessed via serial imaging data.
Effective Half-Life
Time frame: From first dose of study drug through end of treatment (~36-48 weeks)
Effective half-life of the study drug in the whole body, major organs, and tumor lesions determined by serial imaging.
3 secondary outcomes
The proportion of patients with a PSA change from baseline
Time frame: From first dose of study drug through end of treatment (~36-48 weeks)
Objective Response Rate (ORR)
Time frame: From first dose of study drug through efficacy follow-up period (Up to approximately 5 years)
Radiographic progression-free survival (rPFS)
Time frame: From first dose of study drug through efficacy follow-up period (Up to approximately 5 years)
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 17 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lu 177-PSMA-3D1015 Injection in people with Metastatic Castration-resistant Prostate Cancer, mCRPC, run by Chunjing Yu at 1 site 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 10 inclusion and 6 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 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 chunjing Yu (15312238622, ycjwxd1978@jiangnan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) (time frame: From first dose of study drug through end of treatment (~36-48 weeks)). The study lists 4 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 17 Apr 2026; AzTrials last refreshed its copy on 28 Oct 2026.