Neoplasms, Prostate
Conditions
Keywords
Metastatic Castration-resistant Prostate Cancer, Risvutatug rezetecan, Ris-Rez, GSK5764227, Enzalutamide, Abiraterone, Antibody-Drug Conjugate, EMBOLD Prostate-302
Brief summary
This study aims to evaluate how well risvutatug rezetecan (Ris-Rez) works in treating prostate cancer compared to best supportive/standard of care (BSC) which may include a hormone therapy with an androgen receptor pathway inhibitors (ARPI), by checking whether it makes cancers smaller or disappear completely, if it helps participants live longer, and/or feel better. The study is also assessing whether Ris-Rez is safe and tolerated well by participants and aims to provide a better understanding of the side effects of the drug.
Interventions
BIOLOGICALRisvutatug rezetecan (Ris-Rez)
Risvutatug rezetecan (Ris-Rez) will be administered.
DRUGEnzalutamide
Enzalutamide will be administered.
DRUGAbiraterone
Abiraterone will be administered.
DRUGPrednisone
Prednisone will be administered along with Abiraterone.
DRUGPrednisolone
Prednisolone will be administered along with Abiraterone.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants ≥18 years of age * Has histologically or cytologically confirmed adenocarcinoma of the prostate. * Has an Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1, with no deterioration in the 2 weeks before randomization. * Has a life expectancy of at least 4 months. * Has adequate organ function
Exclusion criteria
* Pathological finding consistent with small cell, neuroendocrine carcinoma of the prostate, mixed histologies or any histology different from adenocarcinoma. * Participants with known mismatch repair deficient (dMMR)/MSI-H/TMB-H status and eligible for immune checkpoint inhibitor therapy, * Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas \[e.g., breast, cervix\] with no evidence of metastatic disease. * Has undergone major surgery, including local prostate intervention (except prostate biopsy), within 28 days before the date of randomization, * Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose. * Known active infectious diseases requiring systemic treatment or known human immunodeficiency virus (HIV) * Has untreated brain or central nervous system (CNS) metastases or brain/CNS metastases that have progressed * Has received systemic immunosuppressive agents within 30 days prior to first dose of study intervention (or requires long-term administration \[30 days or longer\]). * Has received any prior therapy with an ADC with a topoisomerase 1 inhibitor (TOPO1-inhibitor) payload
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Progression-Free Survival (rPFS) per PCWG3 by BICR | Up to approximately 169 weeks | rPFS is defined as time from randomization to the first documented radiographic disease progression, per Prostate cancer clinical trials working group 3 (PCWG3) as assessed by Blinded Independent Central Review (BICR) or death due to any cause, whichever occurs first. |
| Overall Survival (OS) | Up to approximately 169 weeks | OS is defined as the time from randomization to date of death by any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Pain Progression (TTPP) | Up to approximately 169 weeks | — |
| rPFS by Investigator assessment | Up to approximately 169 weeks | rPFS is defined as time from randomization to the first documented radiographic disease progression per PCWG3 as assessed by Investigator or death due to any cause, whichever occurs first. |
| Confirmed Objective Response Rate (cORR) | Up to approximately 169 weeks | cORR is defined as the percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) per PCWG3 by BICR. |
| Duration of Response (DoR) | Up to approximately 169 weeks | DoR defined as the time from the date of first confirmed response (CR or PR) to the date of first documented PD per PCWG3 as assessed by BICR or death due to any cause, whichever comes first. |
| Time to Prostate-specific antigen (PSA) progression | Up to approximately 169 weeks | Time to PSA progression is defined as the time from randomization to PSA progression according to PCWG3 criteria. |
| Prostate-specific antigen 50 (PSA50) response | Up to approximately 169 weeks | PSA50 is defined as the proportion of participants having a ≥50% post-baseline PSA reduction from baseline with a consecutive confirmation assessment at least 3 weeks later. |
| Time to first Symptomatic Skeletal-Related Event (SSRE) | Up to approximately 169 weeks | Time to first SSRE is defined as the time from randomization to first occurrence of any of the following symptomatic skeletal-related events: * Use of EBRT to prevent or relieve skeletal symptoms . * New symptomatic pathological bone fracture (vertebral or non-vertebral). * New symptomatic spinal cord compression. * Tumor-related orthopedic surgical intervention |
| Number of participants with adverse event (AEs), serious adverse event (SAEs), Adverse event of special interest (AESIs) by severity | Up to approximately 169 weeks | — |
| Number of participants with AEs leading to dose modifications or study intervention discontinuation | Up to approximately 169 weeks | — |
| Serum concentration of Ris-Rez (conjugated antibody and payload) | Up to approximately 84 days | — |
| Number of participants with Antidrug antibody (ADA) and Neutralizing Antibody (NAb) against Ris-Rez | Up to approximately 169 weeks | — |
| Titers of ADA against Ris-Rez | Up to approximately 169 weeks | — |
| Participant-reported experience on study treatment | Up to approximately 169 weeks | Number of participants who reported their experience with study treatment using validated questionnaires will be measured |
Contacts
CONTACTUS GSK Clinical Trials Call Center
CONTACTEU GSK Clinical Trials Call Center
Outcome results
None listed