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PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC)Phase 1NCT07660211

Clinical Evaluation of 177Lu-PSMA-VG01 Injection in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer （mCRPC）

A Phase 1 study testing 177Lu-PSMA-VG01 in people with PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC), run by VitsGen Therapeutics Inc. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a phase I clinical trial conducted in participants with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). After confirmation of PSMA positivity, participants receive intravenous administration of 177Lu-PSMA-VG01. Read more about this study

Who is it for?
Ages 18 to 80 years, men only
What is being tested?
177Lu-PSMA-VG01
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
16 Jun 2026to 6 May 2029
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 to 80 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male participants aged 18 years (inclusive) to 80 years (exclusive) at the time of signing the informed consent.
  • Histologically or cytologically confirmed prostate cancer with no standard treatment options available, or failure/intolerance to standard therapies, or inability to access standard treatment.
  • During the screening period, imaging examinations (within 4 weeks before administration) showed the presence of ≥1 metastatic lesion.
  • ECOG Performance Status score: 0 to 2.
  • Expected survival time exceeds 6 months.
  • All clinically significant toxicities related to prior anti-tumor therapy (e.g., chemotherapy, radiotherapy, etc., excluding Luteinizing Hormone-Releasing Hormone (LHRH) analog therapy) must have resolved to ≤ Grade 1, except for toxicities deemed safe and manageable by the investigator, such as alopecia, peripheral neuropathy ≤ Grade 2, etc. (CTCAE V6.0).
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  • The participant must be fully informed about the study and voluntarily provide written informed consent prior to participation.
  • The participant must be capable of understanding and complying with the requirements of the trial protocol.
  • The participant must use a condom during sexual activity throughout the study period and for 14 weeks after the last dose of study treatment to prevent pregnancy in partners and potential exposure of partners to the investigational product g via semen. Additionally, the participant should refrain from sperm donation during the specified timeframe above.

Who cannot join

  • Having received anti-tumor therapies such as chemotherapy, biological therapy, targeted therapy, or immunotherapy within 4 weeks prior to the first dose of the investigational product, or planning to receive such therapies during the study period.
  • Having received systemic or local radionuclide therapy within 3 months prior to the first dose.
  • Having received other investigational product treatments not yet approved within 4 weeks prior to the first dose of the investigational product, or within five half-lives of that.
  • Having undergone major organ surgery (excluding needle biopsy) or experienced significant trauma within 4 weeks prior to the first dose of the investigational product, or requiring elective surgery during the trial period.
  • Having been diagnosed with other malignancies within the past 2 years (participants with a prior history of malignancy who have received adequate treatment and have remained disease- and treatment-free for over 3 years prior to enrollment are eligible, as are patients with adequately treated non-melanoma skin cancer or superficial bladder cancer).
  • Having symptomatic spinal cord compression or clinical/imaging findings suggestive of impending spinal cord compression.
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  • Known allergy to structural analogs of this product or other excipients.
  • Having a history of immunodeficiency, including a positive HIV test result, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; a history of severe autoimmune diseases deemed unsuitable for enrollment by the investigator; or requiring immunosuppressive therapy for allogeneic organ transplantation.
  • Having severe infections (requiring intravenous antibiotics, antifungals, or antivirals according to clinical practice guidelines), active hepatitis A, active hepatitis B (HBV DNA ≥2000 IU/mL or 10^4 copies/mL; prophylactic antiviral therapy other than interferon is allowed), active hepatitis C (anti-HCV positive and HCV-RNA above the lower limit of detection), or active syphilis infection.
  • Having uncontrolled third-space fluid accumulations (such as significant pleural effusion, ascites or pericardial effusion) deemed unsuitable for enrollment by the investigator.
  • Having a clear history of neurological or psychiatric disorders, including epilepsy or dementia.
  • Other reasons considered by the investigator to make the participant unsuitable for participation in this clinical study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xiaobo Su contact

086+0632-2989679

xiaobo.su@vitsgen.com

China1 site, 1 recruiting

  • Zhong Shan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200032

    Hongcheng Shi, Doctor of Medicine, 086+ 021-64041990, shi.hongcheng@zs-hospital.sh.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase 1, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Biodistribution, Radiation Dosimetry and Preliminary Efficacy of 177Lu-PSMA-VG01 Injection in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)

This is a phase I clinical trial conducted in participants with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). After confirmation of PSMA positivity, participants receive intravenous administration of 177Lu-PSMA-VG01. The objectives are: to evaluate the biodistribution, radiation dosimetry, safety and tolerability of 177Lu-PSMA-VG01 in participants; and to assess the pharmacokinetics (PK), preliminary anti-tumor activity, and in vivo stability of 177Lu-PSMA-VG01 in participants.

Read the detailed description

This is a prospective, single-arm, dose-escalation and open phase I clinical study. 10-24 participants are expected to be enrolled. Participants will sign the informed consent form (ICF) prior to screening.

Only PSMA-positive participants with metastatic castration-resistant prostate cancer (mCRPC) who meet the inclusion criteria and do not meet any exclusion criteria will be enrolled. The successful screened participants will be treated with 177Lu-PSMA-VG01 injection intravenously during the treatment period. Pharmacokinetic (PK) blood samples will be collected, and SPECT/CT imaging will be performed during the clinical study.

Long-term follow-up will last up to 2 years after completion of EOT. Throughout the study period, participants will undergo safety monitoring following drug administration.

Being tested
177Lu-PSMA-VG01

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 177Lu-PSMA-VG01Drug

    Treatment patients

Study groups in NCT07660211
Study groupRoleWhat they receive
177Lu-PSMA-VG01 InjectionExperimentalSuccessfully screened participants will be treated with 177Lu-PSMA-VG01 Injection during the treatment period .
Receives: Drug: 177Lu-PSMA-VG01

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiation dosimetry

    Standard uptake value (SUV), organ accumulation (%ID), absorbed dose (AD), and effective dose (ED) in tumors and target organs

    Measured: Up to 36 weeks

  2. Dose-Limiting Toxicities (DLT)

    Evaluating the safety and tolerability of the 177Lu-PSMA-VG01 injection in participants.

    Measured: Up to 6 weeks

  3. Maximum Tolerate dose（MTD）

    Evaluating the safety and tolerability of the 177Lu-PSMA-VG01 injection in participants.

    Measured: Up to 6 weeks

  4. AE

    Evaluating the safety and tolerability of the 177Lu-PSMA-VG01 injection in participants.

    All Adverse Events (AEs) occurring during the clinical study period will be monitored.

    Measured: Up to 36 weeks

  5. Accumulation (%ID)

    Evaluation of drug biodistribution in major human organs.

    Measured: Up to 36 weeks

  6. Area under the plasma concentration-time curve from time zero to the last measurable concentration（AUC₀-last）

    Pharmacokinetics (PK) of 177Lu-PSMA-VG01 in plasma

    Measured: Up to 8 days.

  7. Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC0-inf)

    Pharmacokinetics (PK) of 177Lu-PSMA-VG01 in plasma

    Measured: Up to 8 days .

  8. Maximum plasma concentration (Cmax)

    Pharmacokinetics (PK) of 177Lu-PSMA-VG01 in plasma

    Measured: Up to 8 days .

Secondary outcomes (3)

  1. Objective Response Rate (ORR)

    Measured: Up to 2 years after completing the End-of-Treatment visit.

  2. radiographic Progression-Free Survival (rPFS)

    Measured: Up to 2 years after completing the End-of-Treatment visit.

  3. PSA response rate

    PSA50 response rate and PSA90 response rate

    Measured: From baseline to 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2026
  2. Study start16 Jun 2026 (estimated)
  3. Primary completion6 May 2027 (estimated)
  4. Study completion6 May 2029 (estimated)

Resources

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
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07660211
Sponsor's protocol ID
2026-078R
Status last verified
Jun 2026
First submitted
7 May 2026
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 177Lu-PSMA-VG01 in people with PSMA-positive Metastatic Castration-resistant Prostate Cancer (mCRPC), run by VitsGen Therapeutics Inc. 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 9 inclusion and 12 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 22 Jun 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 Xiaobo Su (086+0632-2989679, xiaobo.su@vitsgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Radiation dosimetry (time frame: Up to 36 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07660211.

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 22 Jun 2026.

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