Study to Evaluate the Efficacy and Safety of 177Lu-NYM032 Injection in Participants With Progressive, PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC)

NCT07795268 | Not Yet Recruiting Phase 3

• 1 other identifier: Lu03202
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to compare overall survival (OS) in patients with progressive PSMA-positive mCRPC who receive 177Lu-NYM032 in addition to best supportive/best standard of care versus patients treated with best supportive/best standard of care alone.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS is defined as time to death due to any cause

  From date of randomization until date of death from any cause, assessed up to 36months (estimated final OS analysis)

Secondary Outcomes (13)

• Radiographic progression-free survival (rPFS)

  From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 36 months (estimated final OS analysis)

• Number of participants with Treatment Emergent Adverse Events

  From randomization till 30 days safety follow-up, assessed up to 36 months (estimated final OS analysis)

• Overall Response Rate (ORR)

  From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 36 months (estimated final OS analysis)

• Disease control rate (DCR)

  From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 36 months (estimated final OS analysis)

• Duration of Response (DOR)

  From date of randomization until date of progression or date of death from any cause, whichever come first, assessed up to 36 months (estimated final OS analysis)

Study Arms (2)

177Lu-NYM032 plus BSC/BSoC

EXPERIMENTAL

Patients randomized to receive the investigational product will receive 7.4 GBq (+/- 10%) 177Lu-NYM032 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BSC/BSoC) may be used.

Drug: 177Lu-NYM032 injection; Other: Best supportive/best standard of care

BSC/BSoC alone

OTHER

Patients randomized to this arm will receive best supportive/best standard of care (BSC/BSoC) as determined by the investigator.

Other: Best supportive/best standard of care

Interventions

177Lu-NYM032 injection DRUG

Administered intravenously once every 6 weeks (1 cycle) for a maximum of 6 cycles.

177Lu-NYM032 plus BSC/BSoC

Best supportive/best standard of care OTHER

Best supportive/best standard of care as defined by the local investigator

177Lu-NYM032 plus BSC/BSoC; BSC/BSoC alone

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be male and aged ≥18 years old.
• Patients must have histological, pathological, and/or cytological confirmation of prostate cancer.
• Patient's serum/plasma testosterone level must be at a castrate level (\<50 ng/dL or \<1.7 nmol/L).
• Participants must have ≥1 metastatic lesion that is present on baseline CT, MRI, or bone scan imaging obtained ≤ 28 days prior to randomization.
• Patients must have progressive mCRPC. Documented progressive mCRPC will be based on at least 1 of the following criteria:
• Serum PSA progression defined as 2 consecutive increases in PSA over a previous reference value measured at least 1 week prior. The minimal start value is 2.0 ng/mL.
• Soft-tissue progression defined \[PCWG3-modified RECIST v1.1 (Eisenhauer et al 2009, Scher et al 2016)\]
• Progression of bone disease: appearance of 2 or more new bone lesions on bone scan (PCWG3 criteria (Scher et al 2016))
• Patients must have a positive 68Ga-NYM032 PET/CT scan.
• Patients must have an ECOG performance status of 0 to 2.
• Patients must have a life expectancy ≥ 6 months.
• Participants must have been previously treated with at least 1 novel androgen receptor pathway inhibitor (ARPI) (e.g., abiraterone and/or enzalutamide) and at least 1, but no more than 2, previous taxane-based chemotherapy regimens. A taxane-based chemotherapy regimen is defined as a minimum exposure of 2 cycles of a taxane. If a participant has received only 1 taxane-based chemotherapy regimen, the participant is eligible : if the participant is unwilling to receive a second taxane-based chemotherapy regimen or if the participant's physician deems the participant unsuitable to receive a second taxane-based chemotherapy regimen (e.g., frailty assessed by geriatric or health status evaluation, intolerance, etc.).
• Patients must have adequate organ function:
• Bone marrow reserve:
• White blood cell (WBC) count ≥2.5 x 109/L

You may not qualify if:

• Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy \[including monoclonal antibodies\], excluding ARPI therapy;) anticancer device therapy, radiation therapy, or an investigational drug in a clinical study within 4 weeks prior to day of randomization.
• Previous treatment with any of the following within 6 months of randomization: Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223, hemi-body irradiation.
• Previous PSMA-targeted radioligand therapy is not allowed.
• Patients with a history of Central Nervous System (CNS) metastases must have received therapy (surgery, radiotherapy, gamma knife) and be neurologically stable, asymptomatic, and not receiving corticosteroids for the purposes of maintaining neurologic integrity. Patients with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired.
• Symptomatic cord compression, or clinical or radiologic findings indicative of impending cord compression.
• Any disease involving the cardiac, respiratory, renal, hepatic, or hematologic organ systems that would significantly interfere with completion of the study or confound the determination of the causality of any adverse events in the study.
• Severe urinary incontinence, hydronephrosis, severe voiding dysfunction, or other related conditions. Note: Participants with bladder outlet obstruction or urinary incontinence that can be managed with available best standard of care (including urinary pads, drainage, etc.) are eligible for study participation.
• Any toxicity related to prior anti-cancer therapies that has not recovered to ≤ Grade 2 according to NCI CTCAE v6.0, except for alopecia.
• Uncontrolled or clinically significant cardiovascular disease, including but not limited to:
• History of symptomatic congestive heart failure (New York Heart Association \[NYHA\] Class III to IV) or any arterial thromboembolic events (e.g., myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack) within 6 months prior to randomization;
• Uncontrolled hypertension, defined as systolic blood pressure (SBP) ≥160 mmHg and/or diastolic blood pressure (DBP) ≥100 mmHg despite antihypertensive therapy;
• Serious cardiac arrhythmias requiring treatment;
• Prolonged corrected QT interval using Fridericia' s formula (QTcF) \>450 ms (male).
• Clinically significant concomitant pulmonary diseases, including but not limited to:
• History of interstitial lung disease (ILD)/interstitial pneumonia requiring steroid treatment (non-infectious), current ILD/interstitial pneumonia, or suspected ILD/interstitial pneumonia that cannot be ruled out by imaging assessment;

Sponsors & Collaborators

• Norroy Bioscience Co., LTD: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start: August 31, 2026
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): August 31, 2029
• Last Updated: August 31, 2026

Record last verified: 2026-08