Neoplasms, ProstatePhase 3NCT07802704
A Study of Risvutatug Rezetecan in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) [EMBOLD Prostate-302]
A Phase 3 study testing Risvutatug rezetecan (Ris-Rez), Enzalutamide and Abiraterone in people with Neoplasms, Prostate, run by GlaxoSmithKline at 6 sites in 4 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Neoplasms, Prostate
- What is being tested?
- Risvutatug rezetecan (Ris-Rez), Enzalutamide and Abiraterone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 684 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 1 Sep 2026to 5 Dec 2029
- Phase
- Phase 3
- 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
- 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
6 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 4 countries
Japan2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Tokyo, 135-8550
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Tottori, 683-8504
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
South Korea2 sites, 2 recruiting
- Recruiting
GSK Investigational Site
Gyeonggi-do, 10408
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Seoul, Seoul Teugbyeolsi, 3080
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Australia1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Auchenflower, Queensland, 4066
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
Canada1 site, 1 recruiting
- Recruiting
GSK Investigational Site
Montreal, Quebec, H4A 0B1
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: A Phase 3 Randomized Study to Evaluate the Safety and Efficacy of Risvutatug Rezetecan, a B7-H3 Antibody Drug Conjugate (ADC) in Participants With Metastatic Castration-resistant Prostate Cancer (EMBOLD Prostate-302)
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.
- Conditions
- Neoplasms, Prostate
- Being tested
- Risvutatug rezetecan (Ris-Rez), Enzalutamide, Abiraterone, Prednisone, Prednisolone
- Keywords
- Metastatic Castration-resistant Prostate Cancer, Risvutatug rezetecan, Ris-Rez, GSK5764227, Enzalutamide, Abiraterone, Antibody-Drug Conjugate, EMBOLD Prostate-302
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risvutatug rezetecan (Ris-Rez)Biological
Risvutatug rezetecan (Ris-Rez) will be administered.
EnzalutamideDrug
Enzalutamide will be administered.
AbirateroneDrug
Abiraterone will be administered.
PrednisoneDrug
Prednisone will be administered along with Abiraterone.
PrednisoloneDrug
Prednisolone will be administered along with Abiraterone.
| Study group | Role | What they receive |
|---|---|---|
| Risvutatug rezetecan (Ris-Rez) | Experimental | Participants will receive Risvutatug rezetecan (Ris-Rez). Receives: Biological: Risvutatug rezetecan (Ris-Rez) |
| Standard of Care | Active comparator | Participants will receive physician's choice of best supportive/standard of care (BSC), with or without androgen receptor pathway inhibitors (ARPI) Enzalutamide, Abiraterone (with Prednisone or Prednisolone). Receives: Drug: Enzalutamide; Drug: Abiraterone; Drug: Prednisone; Drug: Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic Progression-Free Survival (rPFS) per PCWG3 by BICR
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.
Measured: Up to approximately 169 weeks
Overall Survival (OS)
OS is defined as the time from randomization to date of death by any cause.
Measured: Up to approximately 169 weeks
Secondary outcomes (13)
Time to Pain Progression (TTPP)
Measured: Up to approximately 169 weeks
rPFS by Investigator assessment
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.
Measured: Up to approximately 169 weeks
Confirmed Objective Response Rate (cORR)
cORR is defined as the percentage of participants with a confirmed Complete Response (CR) or Partial Response (PR) per PCWG3 by BICR.
Measured: Up to approximately 169 weeks
Duration of Response (DoR)
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.
Measured: Up to approximately 169 weeks
Time to Prostate-specific antigen (PSA) progression
Time to PSA progression is defined as the time from randomization to PSA progression according to PCWG3 criteria.
Measured: Up to approximately 169 weeks
Prostate-specific antigen 50 (PSA50) response
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.
Measured: Up to approximately 169 weeks
Time to first Symptomatic Skeletal-Related Event (SSRE)
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
Measured: Up to approximately 169 weeks
Number of participants with adverse event (AEs), serious adverse event (SAEs), Adverse event of special interest (AESIs) by severity
Measured: Up to approximately 169 weeks
Number of participants with AEs leading to dose modifications or study intervention discontinuation
Measured: Up to approximately 169 weeks
Serum concentration of Ris-Rez (conjugated antibody and payload)
Measured: Up to approximately 84 days
Number of participants with Antidrug antibody (ADA) and Neutralizing Antibody (NAb) against Ris-Rez
Measured: Up to approximately 169 weeks
Titers of ADA against Ris-Rez
Measured: Up to approximately 169 weeks
Participant-reported experience on study treatment
Number of participants who reported their experience with study treatment using validated questionnaires will be measured
Measured: Up to approximately 169 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start1 Sep 2026
- Primary completion5 Dec 2029 (estimated)
- Study completion5 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, ProstateStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 684 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07802704
- Sponsor's protocol ID
- 300145
- Other IDs
- 2026-525558-13-00
- Status last verified
- Sep 2026
- First submitted
- 28 Aug 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized Study to Evaluate the Safety and Efficacy of Risvutatug Rezetecan, a B7-H3 Antibody Drug Conjugate (ADC) in Participants With Metastatic Castration-resistant Prostate Cancer (EMBOLD Prostate-302)
- ClinicalTrials.gov ID
- NCT07802704
- Acronym / sponsor ID
- 300145
- Conditions
- Neoplasms, Prostate
- Keywords
- Metastatic Castration-resistant Prostate Cancer, Risvutatug rezetecan, Ris-Rez, GSK5764227, Enzalutamide, Abiraterone, Antibody-Drug Conjugate, EMBOLD Prostate-302
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 684 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 5 Dec 2029 (estimated)
- Study completion
- 5 Dec 2029 (estimated)
- First posted
- 3 Sep 2026 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risvutatug rezetecan (Ris-Rez) | Experimental | Biological: Risvutatug rezetecan (Ris-Rez)Participants will receive Risvutatug rezetecan (Ris-Rez). |
| Standard of Care | Active comparator | Drug: Enzalutamide, Drug: Abiraterone, Drug: Prednisone, Drug: PrednisoloneParticipants will receive physician's choice of best supportive/standard of care (BSC), with or without androgen receptor pathway inhibitors (ARPI) Enzalutamide, Abiraterone (with Prednisone or Prednisolone). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Risvutatug rezetecan (Ris-Rez)Risvutatug rezetecan (Ris-Rez) will be administered. | Biological | Risvutatug rezetecan (Ris-Rez) |
| EnzalutamideEnzalutamide will be administered. | Drug | Standard of Care |
| AbirateroneAbiraterone will be administered. | Drug | Standard of Care |
| PrednisonePrednisone will be administered along with Abiraterone. | Drug | Standard of Care |
| PrednisolonePrednisolone will be administered along with Abiraterone. | Drug | Standard of Care |
Primary outcome
Radiographic Progression-Free Survival (rPFS) per PCWG3 by BICR
Time frame: 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)
Time frame: Up to approximately 169 weeks
OS is defined as the time from randomization to date of death by any cause.
13 secondary outcomes
Time to Pain Progression (TTPP)
Time frame: Up to approximately 169 weeks
rPFS by Investigator assessment
Time frame: Up to approximately 169 weeks
Confirmed Objective Response Rate (cORR)
Time frame: Up to approximately 169 weeks
Duration of Response (DoR)
Time frame: Up to approximately 169 weeks
Time to Prostate-specific antigen (PSA) progression
Time frame: Up to approximately 169 weeks
Prostate-specific antigen 50 (PSA50) response
Time frame: Up to approximately 169 weeks
Time to first Symptomatic Skeletal-Related Event (SSRE)
Time frame: Up to approximately 169 weeks
Number of participants with adverse event (AEs), serious adverse event (SAEs), Adverse event of special interest (AESIs) by severity
Time frame: Up to approximately 169 weeks
Number of participants with AEs leading to dose modifications or study intervention discontinuation
Time frame: Up to approximately 169 weeks
Serum concentration of Ris-Rez (conjugated antibody and payload)
Time frame: Up to approximately 84 days
Number of participants with Antidrug antibody (ADA) and Neutralizing Antibody (NAb) against Ris-Rez
Time frame: Up to approximately 169 weeks
Titers of ADA against Ris-Rez
Time frame: Up to approximately 169 weeks
Participant-reported experience on study treatment
Time frame: Up to approximately 169 weeks
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 2 Oct 2026.
- Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
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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.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Risvutatug rezetecan (Ris-Rez), Enzalutamide and Abiraterone in people with Neoplasms, Prostate, run by GlaxoSmithKline at 6 sites in 4 countries.
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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Japan, South Korea, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic Progression-Free Survival (rPFS) per PCWG3 by BICR (time frame: Up to approximately 169 weeks). The study lists 2 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 2 Oct 2026.