Metastatic Castration-resistant Prostate Cancer (mCRPC)Phase 1/2NCT07310355
68Ga-PSMA-0057 and 177Lu-PSMA-0057 in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
A Phase 1/2 study testing 68Ga-PSMA-0057 and 177Lu-PSMA-0057 in people with Metastatic Castration-resistant Prostate Cancer (mCRPC), run by Chengdu StarRay Therapeutics Co., Ltd.
Trial summary
This is a single-arm, open-label, Phase I/II clinical study designed to evaluate the safety, tolerability, pharmacokinetics, dosimetry, pharmacodynamics, and preliminary efficacy of Gallium [68Ga] PSMA-0057 Injection and Lutetium [177Lu] PSMA-0057 Injection as an integrated theranostic regimen in patients with… 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?
- 68Ga-PSMA-0057 and 177Lu-PSMA-0057
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2025to 30 Apr 2030
- Phase
- Phase 1/2
- 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
- Able to communicate well with investigators, understand the study purpose and requirements, voluntarily participate, and sign written informed consent.
- Male, ≥18 years at screening.
- Histologically or cytologically confirmed prostate cancer (excluding neuroendocrine prostate cancer and small cell prostate cancer), previously treated with at least one novel hormonal agent and 1-2 taxane-based regimens, or deemed intolerant to taxanes.
- Serum/plasma testosterone at castrate level (<50 ng/dL or <1.7 nmol/L).
- Documented progressive mCRPC based on ≥1 of the following: PSA progression (two consecutive PSA rises ≥1 week apart from a minimum value of 2.0 ng/mL); soft tissue progression per PCWG3 and RECIST v1.1; or bone progression with ≥2 new lesions.
- PSMA-positive on imaging with 68Ga-PSMA-0057 (within 3 days before treatment start) or other investigator-accepted PSMA tracers (within 6 months before treatment start), using criteria in Section 4.8.5.
Show all 15Show fewer
- At least one measurable lesion per RECIST v1.1 and/or at least one bone metastasis per PCWG3.
- Estimated life expectancy ≥12 weeks.
- ECOG performance status 0-1 at baseline.
- Adequate organ and bone marrow function, meeting the following lab criteria:
- 1)Bone Marrow: Absolute Neutrophil Count (ANC) ≥1.5×109/L, Platelets (PLT) ≥100×109/L, White Blood Cell (WBC) count ≥2.5×109/L, Hemoglobin (HGB) ≥9.0 g/dL (no transfusions/growth factors within 14 days prior to screening).
- 2)Liver Function: Serum Total Bilirubin (T-Bil) ≤1.5 ULN (unless Gilbert's syndrome); Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≤3 ULN for non-liver metastasis, or ≤5 ULN for liver metastasis.
- 3)Renal Function: Serum creatinine ≤1.5 ULN, or estimated Glomerular Filtration Rate (eGFR) ≥50 mL/min/1.73m2 (calculated using the MDRD formula).
- 11.Serum albumin concentration ≥30 g/L 12.Toxicities from prior therapies recovered to CTCAE v5.0 Grade 0-1 (alopecia excepted).
- 13.Men with reproductive potential agree to use highly effective contraception from informed consent through 6 months after last study dose and have no plans to donate sperm.
Who cannot join
- History of hypersensitivity to any study drug component or excipients, or history of specific allergic disease requiring systemic therapy, or other serious allergic reactions.
- Prior PSMA-targeted radioligand therapy, or treatment with radionuclides such as Sr-89, Sm-153, Re-186, Re-188, Ra-223, or hemibody radiation within 6 months prior to consent.
- Use of any investigational drug or device within 30 days before consent.
- Systemic anticancer therapy within 28 days or 5 half-lives prior to consent (whichever is longer), including chemotherapy, radiotherapy, immunotherapy, targeted therapy, systemic immunomodulatory drugs, or antitumor traditional Chinese medicines/formulations within 2 weeks before first dose.
- Another malignancy within the past 5 years, except for curatively treated cervical carcinoma in situ, non-melanoma skin cancers, etc.
- Major surgery or significant traumatic injury within 4 weeks before consent.
Show all 17Show fewer
- Active brain metastases or CNS involvement, including untreated symptomatic lesions or those requiring radiation, surgery, or steroids within 1 month prior to screening.
- Symptomatic spinal cord compression or clinical/imaging findings suggestive of impending cord compression.
- Severe arterial/venous thromboembolic events within 6 months prior to screening; history of stroke; uncontrolled hypertension; decompensated heart failure (NYHA III-IV); LVEF <50%; unstable angina; clinically significant arrhythmias requiring intervention.
- Significant acute or chronic infections, including active TB, systemic bacterial or fungal infections requiring systemic therapy.
- Clinically significant COPD or moderate-severe chronic respiratory disease requiring systemic therapy within 6 months before first dose.
- Uncontrolled bladder outlet obstruction or incontinence (patients managed effectively with standard measures are allowed).
- Active autoimmune disease requiring systemic treatment within the past 2 years or likely to recur, or active peptic ulcer disease or bleeding disorders.
- History of solid organ transplantation or allogeneic hematopoietic stem cell transplantation (corneal transplant recipients not requiring immunosuppressants may be included).
- Syphilis, HIV infection, HCV (HCV antibody positive with detectable HCV RNA), or active HBV infection (HBsAg positive with HBV DNA ≥ULN).
- Contraindications to PET-CT or SPECT-CT imaging, or factors deemed by the investigator to preclude adequate imaging acquisition and interpretation.
- Any condition judged by the investigator likely to interfere with compliance or study participation, or impair the ability to give informed consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Project Manager, Chengdu StarRay Therapeutics Co., Ltd. contact
About this study
Official title: A Phase I/II, Single-Arm, Open-Label, Dose-Escalation and Expansion Study of 68Ga-PSMA-0057 and 177Lu-PSMA-0057 in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
This is a single-arm, open-label, Phase I/II clinical study designed to evaluate the safety, tolerability, pharmacokinetics, dosimetry, pharmacodynamics, and preliminary efficacy of Gallium [68Ga] PSMA-0057 Injection and Lutetium [177Lu] PSMA-0057 Injection as an integrated theranostic regimen in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). The study consists of a Phase I dose-escalation phase to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of 177Lu-PSMA-0057, followed by a Phase II dose-expansion phase to further evaluate preliminary antitumor efficacy and confirm safety and pharmacologic profiles. Eligible participants will receive 68Ga-PSMA-0057 for PET imaging and 177Lu-PSMA-0057 for radioligand therapy. Key objectives include characterization of safety, tolerability, pharmacokinetics, dosimetry, pharmacodynamics, and preliminary therapeutic activity.
- Being tested
- 68Ga-PSMA-0057, 177Lu-PSMA-0057
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-PSMA-0057Drug
68Ga-PSMA-0057 IV administered as imaging agent for PET/CT.
177Lu-PSMA-0057Drug
177Lu-PSMA-0057 radiopharmaceutical solution for injection.
| Study group | Role | What they receive |
|---|---|---|
| 177Lu-PSMA-0057 Treatment | Experimental | 1. Dose Escalation：Enroll patients with PSMA-positive progressive mCRPC who have received at least one novel endocrine therapy and 1-2 taxane-based treatment regimens, or are deemed intolerant by the investigator. Dose escalation will follow the "rolling six design" method, with two planned dose levels: 3.7 GBq and 6.0 GBq of fractionated 177Lu-PSMA-0057, administered every 6 weeks (Q6W), up to a maximum of 6 doses.
2. Dose Expansion：After determining the RP2D of 177Lu-PSMA-0057, a phase II expansion will be conducted at the RP2D level (expected to expand only one dose level). Treatment will be administered every 6 weeks (Q6W), up to a maximum of 6 doses. Receives: Drug: 68Ga-PSMA-0057; Drug: 177Lu-PSMA-0057 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events [68Ga-PSMA-0057]
Number of participants with adverse events as assessed by NCI-CTCAE v5.0
Measured: 3 days
Incidence of adverse events [177Lu-PSMA-0057]
Number of participants with adverse events as assessed by NCI-CTCAE v5.0
Measured: up to 2 years
Incidence of dose limiting toxicities [177Lu-PSMA-0057]
Number of participants with dose limiting toxicities
Measured: 6 weeks
Preliminary efficacy: PSA50 response rate (Phase II)
Proportion of patients achieving ≥50% reduction in prostate-specific antigen (PSA) from baseline.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start30 Dec 2025 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Apr 2030 (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 (mCRPC)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu StarRay Therapeutics Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310355
- Sponsor's protocol ID
- SRT007-101
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (demographics, safety, PK/PD, efficacy) will be shared upon reasonable request after publication of the primary results. Access requires a signed Data Use Agreement and sponsor approval. Requests should be submitted to clinicaltrials@starray.com
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Single-Arm, Open-Label, Dose-Escalation and Expansion Study of 68Ga-PSMA-0057 and 177Lu-PSMA-0057 in Patients With PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT07310355
- Acronym / sponsor ID
- SRT007-101
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Chengdu StarRay Therapeutics Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 30 Dec 2025 (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 a single-arm, open-label, Phase I/II clinical study designed to evaluate the safety, tolerability, pharmacokinetics, dosimetry, pharmacodynamics, and preliminary efficacy of Gallium [68Ga] PSMA-0057 Injection and Lutetium [177Lu] PSMA-0057 Injection as an integrated theranostic regimen in patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC). The study consists of a Phase I dose-escalation phase to determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) of 177Lu-PSMA-0057, followed by a Phase II dose-expansion phase to further evaluate preliminary antitumor efficacy and confirm safety and pharmacologic profiles. Eligible participants will receive 68Ga-PSMA-0057 for PET imaging and 177Lu-PSMA-0057 for radioligand therapy. Key objectives include characterization of safety, tolerability, pharmacokinetics, dosimetry, pharmacodynamics, and preliminary therapeutic activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 177Lu-PSMA-0057 Treatment | Experimental | Drug: 68Ga-PSMA-0057, Drug: 177Lu-PSMA-00571. Dose Escalation：Enroll patients with PSMA-positive progressive mCRPC who have received at least one novel endocrine therapy and 1-2 taxane-based treatment regimens, or are deemed intolerant by the investigator. Dose escalation will follow the "rolling six design" method, with two planned dose levels: 3.7 GBq and 6.0 GBq of fractionated 177Lu-PSMA-0057, administered every 6 weeks (Q6W), up to a maximum of 6 doses. 2. Dose Expansion：After determining the RP2D of 177Lu-PSMA-0057, a phase II expansion will be conducted at the RP2D level (expected to expand only one dose level). Treatment will be administered every 6 weeks (Q6W), up to a maximum of 6 doses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Able to communicate well with investigators, understand the study purpose and requirements, voluntarily participate, and sign written informed consent.
- Male, ≥18 years at screening.
- Histologically or cytologically confirmed prostate cancer (excluding neuroendocrine prostate cancer and small cell prostate cancer), previously treated with at least one novel hormonal agent and 1-2 taxane-based regimens, or deemed intolerant to taxanes.
- Serum/plasma testosterone at castrate level (<50 ng/dL or <1.7 nmol/L).
- Documented progressive mCRPC based on ≥1 of the following: PSA progression (two consecutive PSA rises ≥1 week apart from a minimum value of 2.0 ng/mL); soft tissue progression per PCWG3 and RECIST v1.1; or bone progression with ≥2 new lesions.
Key exclusion criteria (17 listed)
- History of hypersensitivity to any study drug component or excipients, or history of specific allergic disease requiring systemic therapy, or other serious allergic reactions.
- Prior PSMA-targeted radioligand therapy, or treatment with radionuclides such as Sr-89, Sm-153, Re-186, Re-188, Ra-223, or hemibody radiation within 6 months prior to consent.
- Use of any investigational drug or device within 30 days before consent.
- Systemic anticancer therapy within 28 days or 5 half-lives prior to consent (whichever is longer), including chemotherapy, radiotherapy, immunotherapy, targeted therapy, systemic immunomodulatory drugs, or antitumor traditional Chinese medicines/formulations within 2 weeks before first dose.
- Another malignancy within the past 5 years, except for curatively treated cervical carcinoma in situ, non-melanoma skin cancers, etc.
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 |
|---|---|---|
| 68Ga-PSMA-005768Ga-PSMA-0057 IV administered as imaging agent for PET/CT. | Drug | 177Lu-PSMA-0057 Treatment |
| 177Lu-PSMA-0057177Lu-PSMA-0057 radiopharmaceutical solution for injection. | Drug | 177Lu-PSMA-0057 Treatment |
Primary outcome
Incidence of adverse events [68Ga-PSMA-0057]
Time frame: 3 days
Number of participants with adverse events as assessed by NCI-CTCAE v5.0
Incidence of adverse events [177Lu-PSMA-0057]
Time frame: up to 2 years
Number of participants with adverse events as assessed by NCI-CTCAE v5.0
Incidence of dose limiting toxicities [177Lu-PSMA-0057]
Time frame: 6 weeks
Number of participants with dose limiting toxicities
Preliminary efficacy: PSA50 response rate (Phase II)
Time frame: up to 2 years
Proportion of patients achieving ≥50% reduction in prostate-specific antigen (PSA) from baseline.
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 30 Dec 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (demographics, safety, PK/PD, efficacy) will be shared upon reasonable request after publication of the primary results. Access requires a signed Data Use Agreement and sponsor approval. Requests should be submitted to clinicaltrials@starray.com
Related trials for Metastatic Castration-resistant Prostate Cancer (mCRPC)
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingObservational study
ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
Prostate Cancer, Prostate Adenocarcinoma
Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
Active, not recruitingPhase 3
Talazoparib + Enzalutamide vs. Enzalutamide Monotherapy in mCRPC
mCRPC
RecruitingPhase 3
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
Prostate Cancer Metastatic
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.
Project Manager, Chengdu StarRay Therapeutics Co., Ltd. contact
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 68Ga-PSMA-0057 and 177Lu-PSMA-0057 in people with Metastatic Castration-resistant Prostate Cancer (mCRPC), run by Chengdu StarRay Therapeutics Co., Ltd.
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 15 inclusion and 17 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: opening soon, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Project Manager, Chengdu StarRay Therapeutics Co., Ltd. (021-33987000, starraytx@fosunpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events [68Ga-PSMA-0057] (time frame: 3 days). 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 30 Dec 2025.