Metastatic Castration-resistant Prostate CancerPhase 2ENCORENCT04754191
Enfortumab Vedotin as Monotherapy in Patients With Metastatic Castration-Resistant Prostate Cancer
A Phase 2 study testing Enfortumab vedotin in people with Metastatic Castration-resistant Prostate Cancer, run by University of Utah at 1 site in United States.
Trial summary
This is an open-label, phase II umbrella trial assessing the anti-tumor activity of enfortumab alone and in combination with other anti-cancer agents in subjects with metastatic castration-resistant prostate cancer. The trial will open to enrollment in Cohort A, enfortumab monotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- Enfortumab vedotin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2022to Jan 2027
- Phase
- Phase 2
- 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
- Male subject aged ≥ 18 years.
- Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology.
- Diagnosis of metastatic or locally advanced, inoperable disease that cannot be treated with definitive intent
- Castrate levels of testosterone as defined as < 50 ng/dL (1.73 nmol/L).
- Prior treatment with at least three or more cycles of taxane therapy (docetaxel or cabazitaxel).
- Note: Docetaxel in the newly diagnosed metastatic setting and docetaxel rechallenge allowed.
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- Prior treatment with at least one prior Novel Hormone Therapy (NHT), defined as second-generation antiandrogen therapies that include but are not limited to abiraterone acetate, enzalutamide, apalutamide, and darolutamide.
- Subject has received or refused therapies which have shown to improve overall survival and are recommended per National Comprehensive Cancer Network (NCCN) guidelines prior to enrollment in trial. Such agents include but are not limited to docetaxel, cabazitaxel, sipuleucel-T, olaparib, rucaparib, radium-223 and lutetium (177Lu) vipivotide tetraxetan depending on patient eligibility.
- Had disease progression on or after NHT prior to enrolling in the study.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
- Adequate organ function as defined as:
- Hematologic:
- White blood cell count (WBC) ≥ 2000/mm3
- Absolute neutrophil count (ANC) ≥ 1500/mm3
- Platelet count ≥ 100,000/mm3
- Hemoglobin ≥ 9g/dL
- Hepatic:
- Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN) unless there is a known history of Gilbert's syndrome.
- Aspartate aminotransferase (AST)(SGOT)/Alanine aminotransferase (ALT)(SGPT) ≤ 5 × institutional ULN
- Renal:
- Estimated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault formula:
- Highly effective contraception throughout the study as described in Section 7.4.
- Discontinued all previous treatments for cancer (except androgen-deprivation therapy and bone loss prevention treatment) 28 days prior to starting study therapy.
- Recovery to baseline or ≤ Grade 1 CTCAE v 5.0 from toxicities related to any prior treatments, unless Adverse Event(s) (AE(s)) are clinically non-significant and/or stable on supportive therapy as determined by the treating physician.
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
Who cannot join
- Prior or concurrent malignancy (other than adenocarcinoma of the prostate). Note: Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial as approved by the Principal Investigator.
- The subject has an uncontrolled, significant intercurrent or recent illness that would preclude safe study participation.
- Clinically significant cardiovascular disease: myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (> New York Heart Association Classification Class IIB) or a serious cardiac arrhythmia requiring medication.
- Known HIV infection with a detectable viral load at the time of screening. Note: Patients on effective antiretroviral therapy with an undetectable viral load at the time of screening are eligible for this trial.
- Known chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection with a detectable viral load.
- Note: Patients with an undetectable HBV viral load are eligible. Patients with an undetectable HCV viral load are eligible.
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- Live attenuated vaccinations within ≤ 4 weeks of the first study therapy and while on trial is prohibited.
- Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v5.0 Grade ≥ 3).
- Subjects taking prohibited medications as described in Section 6.3. A washout period of prohibited medications for a period of at least 5 half-lives or as clinically indicated should occur prior to the start of treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: A Phase 2 Umbrella Protocol of Enfortumab Vedotin as Monotherapy and Combined With Other Agents in Patients With Metastatic Castration-Resistant Prostate Cancer
This is an open-label, phase II umbrella trial assessing the anti-tumor activity of enfortumab alone and in combination with other anti-cancer agents in subjects with metastatic castration-resistant prostate cancer. The trial will open to enrollment in Cohort A, enfortumab monotherapy. Additional cohorts may be added as new drug combinations are identified.
- Being tested
- Enfortumab vedotin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enfortumab vedotinDrug
Cohort A will be treated with enfortumab vedotin on a 28 day cycle for up to 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Treatment: all patients | Experimental | Enfortumab will be administered in monotherapy on days 1, 8, and 15 as part of a 28-day cycle at 1.25 mg/kg up to 125 mg. Receives: Drug: Enfortumab vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion subjects achieving a protocol-defined response (as defined below):
To assess the anti-tumor action of the study therapy in subjects with metastatic castrate-resistant prostate cancer, as represented by the proportion of subjects achieving one of the following outcomes:
Objective response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; Confirmed conversion of circulating tumor cell count (CTC) to <5/7.5 mL blood; Prostate Specific Antigen (PSA) decline ≥ 50% from baseline; or Stable disease ≥ 6 months per Prostate Cancer Working Group 3 (PCWG3)-modified RECIST 1.1
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start5 Jun 2022
- Primary completion22 Apr 2025
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc
- Responsible party
- Sponsor
- Investigators
- Umang Swami, MD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754191
- Sponsor's protocol ID
- HCI137651
- Acronym
- ENCORE
- Status last verified
- Jan 2026
- First submitted
- 9 Feb 2021
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Umbrella Protocol of Enfortumab Vedotin as Monotherapy and Combined With Other Agents in Patients With Metastatic Castration-Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT04754191
- Acronym / sponsor ID
- ENCORE / HCI137651
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc
- Study start
- 5 Jun 2022 (actual)
- Primary completion
- 22 Apr 2025 (actual)
- Study completion
- Jan 2027 (estimated)
- First posted
- 15 Feb 2021 (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 is an open-label, phase II umbrella trial assessing the anti-tumor activity of enfortumab alone and in combination with other anti-cancer agents in subjects with metastatic castration-resistant prostate cancer. The trial will open to enrollment in Cohort A, enfortumab monotherapy. Additional cohorts may be added as new drug combinations are identified.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment: all patients | Experimental | Drug: Enfortumab vedotinEnfortumab will be administered in monotherapy on days 1, 8, and 15 as part of a 28-day cycle at 1.25 mg/kg up to 125 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Male subject aged ≥ 18 years.
- Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology.
- Diagnosis of metastatic or locally advanced, inoperable disease that cannot be treated with definitive intent
- Castrate levels of testosterone as defined as < 50 ng/dL (1.73 nmol/L).
- Prior treatment with at least three or more cycles of taxane therapy (docetaxel or cabazitaxel).
Key exclusion criteria (9 listed)
- Prior or concurrent malignancy (other than adenocarcinoma of the prostate). Note: Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial as approved by the Principal Investigator.
- The subject has an uncontrolled, significant intercurrent or recent illness that would preclude safe study participation.
- Clinically significant cardiovascular disease: myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (> New York Heart Association Classification Class IIB) or a serious cardiac arrhythmia requiring medication.
- Known HIV infection with a detectable viral load at the time of screening. Note: Patients on effective antiretroviral therapy with an undetectable viral load at the time of screening are eligible for this trial.
- Known chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection with a detectable viral load.
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 |
|---|---|---|
| Enfortumab vedotinCohort A will be treated with enfortumab vedotin on a 28 day cycle for up to 12 months. | Drug | Treatment: all patients |
Primary outcome
Proportion subjects achieving a protocol-defined response (as defined below):
Time frame: 12 months
To assess the anti-tumor action of the study therapy in subjects with metastatic castrate-resistant prostate cancer, as represented by the proportion of subjects achieving one of the following outcomes: Objective response by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; Confirmed conversion of circulating tumor cell count (CTC) to <5/7.5 mL blood; Prostate Specific Antigen (PSA) decline ≥ 50% from baseline; or Stable disease ≥ 6 months per Prostate Cancer Working Group 3 (PCWG3)-modified RECIST 1.1
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 12 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Metastatic Castration-resistant Prostate Cancer
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STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
Metastatic Castration-Resistant Prostate Cancer
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
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ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Metastatic Castration-resistant Prostate Cancer
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. This study is not recruiting at the moment.
Umang Swami, MD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enfortumab vedotin in people with Metastatic Castration-resistant Prostate Cancer, run by University of Utah at 1 site in United States.
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 25 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: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion subjects achieving a protocol-defined response (as defined below): (time frame: 12 months). 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 12 Feb 2026.