A Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Dosimetry of [177Lu]Lu-PSMA-617 in Chinese Adult Male Patients With Progressive PSMA-Positive mCRPC

NCT05670106 | Active Not Recruiting Phase 2

• 1 other identifier: CAAA617A12201
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 17

Brief Summary

The purpose of this study was to assess the efficacy, safety, tolerability, Pharmacokinetic(s) (PK) and dosimetry of \[177Lu\]Lu-PSMA-617 when administered in addition to Best Supportive/Best Standard of Care (BSC/BSoC) in Chinese participants with progressive PSMA-positive mCRPC who received at least 1 novel androgen receptor pathway inhibitor (ARPI) and were previously treated with 1 to 2 taxane regimens. Furthermore, the safety, PK, and dosimetry of \[68Ga\]Ga-PSMA-11 were assessed. Data from this study will be used to bridge global pivotal phase III study (VISION, AAA617A12301) and to support China registration of \[177Lu\]Lu-PSMA-617 as a novel anticancer modality, namely radioligand therapy, in mCRPC.

Conditions

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Keywords

Chinese adult male population; therapeutic agent lutetium (177Lu) vipivotide tetraxetan; AAA617; [177Lu]Lu-PSMA-617; radiolabeled compound gallium (68Ga) gozetotide; [68Ga]Ga-PSMA-11; Progressive PSMA-Positive Metastatic Castration-Resistant Prostate Cancer; Overall Response Rate; ORR; Prostate-specific Membrane Antigen; PSMA; Taxane; Androgen Receptor Pathway Inhibitor; ARPI

Outcome Measures

Primary Outcomes (1)

• Main part: Confirmed Overall Response Rate (ORR) per Blinded Independent Central Review (BICR)

  Confirmed Overall Response Rate (ORR) is defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR). ORR is based on PCWG3-modified RECIST v1.1 response for patients with measurable disease at baseline.

  From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first, approx. 1 year

Secondary Outcomes (20)

• Main & extension parts: Radiographic progression free survival (rPFS)

  From date of randomization until date of radiographic progression or date of death from any cause, whichever comes first.

• Main & extension parts: Overall survival (OS)

  From date of randomization until date of death from any cause.

• Main & extension parts: Overall response rate (ORR)

  From date of randomization till radiographic progression or date of death from any cause.

• Main & extension parts: Disease control rate (DCR)

  From date of randomization till radiographic progression or date of death from any cause.

• Main & extension parts: Duration of response (DOR)

  From date of randomization until date of progression or date of death from any cause.

Study Arms (1)

[177Lu]Lu-PSMA-617 plus best supportive/best standard of care (BS/BSOC)

EXPERIMENTAL

Patients will receive the investigational product 7.4 GBq (+/- 10%) 177Lu-PSMA-617 intravenously every 6 weeks (+/- 1 week) for a maximum of 6 cycles. Best supportive/best standard of care (BS/BSOC) may be used

Drug: [177Lu]Lu-PSMA-617; Other: Best supportive/best standard of care (BS/BSOC); Drug: 68Ga-PSMA-11

Interventions

[177Lu]Lu-PSMA-617 DRUG

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

Also known as: AAA617

[177Lu]Lu-PSMA-617 plus best supportive/best standard of care (BS/BSOC)

Best supportive/best standard of care (BS/BSOC) OTHER

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

[177Lu]Lu-PSMA-617 plus best supportive/best standard of care (BS/BSOC)

68Ga-PSMA-11 DRUG

Administered single intravenous dose of approximately 150 MBq. Administered dose could not be lower than 111 MBq or higher than 259 MBq (3 - 7 mCi).

[177Lu]Lu-PSMA-617 plus best supportive/best standard of care (BS/BSOC)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent must be obtained before any assessment is performed.
• Participants must be Chinese male adults \>= 18 years of age.
• Participants must have histological, pathological, and/or cytological confirmation of prostate cancer.
• Participants must be \[68Ga\]Ga-PSMA-11 PET/CT scan positive, and eligible as determined by the sponsor's central reader according to the VISION read rules.
• Participants must have a castrate level of serum/plasma testosterone (\< 50 ng/dl, or \< 1.7 nmol/L).
• Participants must have received at least one ARPI (such as enzalutamide and/orabiraterone).
• Participants must have been previously treated with at least 1, but no more than 2 previous taxane regimens.
• A taxane regimen is defined as a minimum exposure of 2 cycles of a taxane. If a participant has received only 1 taxane regimen, the participant is eligible if: the participants' physician deems him unsuitable to receive a second taxane regimen (e.g., frailty assessed by geriatric or health status evaluation or intolerance, etc.)
• Documented progressive mCRPC, based on at least 1 of the following criteria:
• Serum/plasma PSA progression defined as 2 consecutive increases in PSA measured at least 1 week apart, the minimal start value is 2.0 ng/ml
• Soft-tissue progression defined based on PCWG3-modified RECIST v1.1 (Eisenhauer et al 2009, Scher et al 2016)
• Progression of bone disease: two new lesions; only positivity on the bone scan defines metastatic disease to bone (PCWG3 criteria (Scher et al 2016)
• Participants must have \>= 1 metastatic lesion that is present on baseline CT, MRI or bone scan imaging obtained =\< 21 days prior to enrollment via central reading.
• In main part: participant must have at least one measurable lesion by PCWG3-modified RECIST v1.1 via central reading
• Participants must have adequate organ function:

You may not qualify if:

• Previous treatment with Strontium-89, Samarium-153, Rhenium-186, Rhenium-188, Radium-223 or hemi-body irradiation.
• Previous PSMA-targeted radioligand therapy.
• Any systemic anti-cancer therapy (e.g. chemotherapy, immunotherapy or biological therapy \[including monoclonal antibodies\], APRI is not included) within 28 days prior to day of enrollment.
• Any investigational agents (e.g. poly adenosine diphosphate-ribosyl polymerase inhibitors \[PARPi\]) within 28 days prior to day of enrollment.
• History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes.
• Other concurrent cytotoxic chemotherapy, immunotherapy, radioligand therapy, or investigational therapy.
• Participants with a history of central nervous system (CNS) metastases who are neurologically unstable, symptomatic, or receiving corticosteroids for the purpose of maintaining neurologic integrity.
• Participants with CNS metastases are eligible if received therapy (surgery, radiotherapy, gamma knife), asymptomatic and neurologically stable without corticosteroids.
• Participants with epidural disease, canal disease and prior cord involvement are eligible if those areas have been treated, are stable, and not neurologically impaired.
• Symptomatic spinal cord compression, or clinical or radiologic findings indicative of impending cord compression.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (17)

Novartis Investigative Site

Guangzhou, Guangdong, 510120, China

Location

Novartis Investigative Site

Zhengzhou, Henan, 450003, China

Location

Novartis Investigative Site

Zhengzhou, Henan, 450008, China

Location

Novartis Investigative Site

Wuhan, Hubei, 430022, China

Location

Novartis Investigative Site

Nanjing, Jiangsu, 210006, China

Location

Novartis Investigative Site

Nanjing, Jiangsu, 210029, China

Location

Novartis Investigative Site

Xian, Shanxi, 710032, China

Location

Novartis Investigative Site

Xian, Shanxi, 710061, China

Location

Novartis Investigative Site

Chengdu, Sichuan, 610041, China

Location

Novartis Investigative Site

Beijing, 100034, China

Location

Novartis Investigative Site

Beijing, 100036, China

Location

Novartis Investigative Site

Beijing, 100730, China

Location

Novartis Investigative Site

Guangzhou, 510060, China

Location

Novartis Investigative Site

Shanghai, 200025, China

Location

Novartis Investigative Site

Shanghai, 200032, China

Location

Novartis Investigative Site

Shanghai, 200080, China

Location

Novartis Investigative Site

Tianjin, 300300, China

Location

MeSH Terms

Interventions

gallium 68 PSMA-11

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: January 4, 2023
• Study Start: May 16, 2023
• Primary Completion: May 17, 2024
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

CN (17)