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

ConditionProstate Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
Age18+
SponsorNorroy Bioscience Co., LTD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 177Lu-NYM032 injection

    Drug

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

  • Best supportive/best standard of care

    Other intervention

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

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: 177Lu-NYM032 plus BSC/BSoCExperimental treatment 2 interventions
Group B: BSC/BSoC aloneOther 1 intervention

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

OS is defined as time to death due to any cause

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

Secondary outcomes

1

Radiographic progression-free survival (rPFS)

rPFS is defined as the time to radiographic progression by PCWG3-modified RECIST v1.1 or death

Time frame
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)
2

Number of participants with Treatment Emergent Adverse Events

The distribution of adverse events (AE) will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.

Time frame
From randomization till 30 days safety follow-up, assessed up to 36 months (estimated final OS analysis)
3

Overall Response Rate (ORR)

ORR is defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) according to PCWG3 modified RECIST 1.1

Time frame
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)
4

Disease control rate (DCR)

DCR is defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) or Stable Disease (SD) in soft tissue according to PCWG3 modified RECIST 1.1

Time frame
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)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Norroy Bioscience Co., LTD

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: