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Antibody-Drug Conjugate

Enfortumab Vedotin for Prostate Cancer (ENCORE Trial)

Phase 2
Recruiting
Led By Umang Swami, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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).
Must not have
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.
Live attenuated vaccinations within ≤ 4 weeks of the first study therapy and while on trial is prohibited.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing enfortumab, a drug that targets and kills cancer cells, in patients with prostate cancer that has spread and does not respond to hormone treatments. The goal is to see how well enfortumab works in these patients.

Who is the study for?
Men over 18 with advanced prostate cancer that's resistant to castration and has worsened after hormone therapy. They must have had prior chemotherapy, maintain low testosterone levels, and have good organ function. Participants need to agree to effective contraception and not have HIV or hepatitis with detectable viral loads.
What is being tested?
The trial is testing Enfortumab Vedotin alone or with other anti-cancer drugs in men whose prostate cancer has spread and doesn't respond to hormone treatment anymore. It's an open-label phase II study where everyone knows what treatment they're getting.
What are the potential side effects?
Enfortumab Vedotin may cause side effects like fatigue, rash, decreased appetite, neuropathy (nerve pain), blood sugar changes, infusion-related reactions, as well as liver and kidney issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has spread and cannot be removed by surgery.
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My testosterone levels are very low, below 50 ng/dL.
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I can take care of myself and perform daily activities.
Select...
My prostate cancer is confirmed without being a small cell type.
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I am a man aged 18 or older.
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I have been treated with a newer hormone therapy for my cancer.
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My blood, liver, and kidney functions meet the required levels for the study.
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I stopped all cancer treatments (except hormone therapy and bone treatments) 28 days ago.
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My condition worsened after hormone therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have serious heart conditions like recent heart attacks or severe heart failure.
Select...
I have not received any live vaccines within the last 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion subjects achieving one of the following: Objective response by RECIST1.1, Confirmed conversion of circulating tumor cell count (CTC) to <5/7.5 mL blood, PSA decline ≥ 50% from baseline, or Stable disease ≥ 6 months per PCWG3 mod.RECIST 1.1

Side effects data

From 2023 Phase 2 trial • 219 Patients • NCT03219333
53%
Fatigue
51%
Alopecia
51%
Decreased appetite
45%
Nausea
43%
Peripheral sensory neuropathy
42%
Diarrhoea
39%
Dysgeusia
35%
Anaemia
32%
Weight decreased
28%
Dry skin
28%
Constipation
27%
Pruritus
25%
Oedema peripheral
24%
Dry eye
23%
Rash maculo-papular
19%
Vomiting
18%
Abdominal pain
17%
Lacrimation increased
17%
Back pain
16%
Dizziness
16%
Vision blurred
16%
Cough
15%
Aspartate aminotransferase increased
14%
Hyperglycaemia
14%
Urinary tract infection
14%
Insomnia
13%
Hypokalaemia
13%
Lipase increased
12%
Hyponatraemia
12%
Pyrexia
12%
Dyspnoea
12%
Rash erythematous
12%
Alanine aminotransferase increased
11%
Arthralgia
11%
Fall
11%
Pain in extremity
11%
Peripheral motor neuropathy
10%
Dehydration
10%
Neutropenia
10%
Skin hyperpigmentation
10%
Amylase increased
9%
Dry mouth
9%
Blood creatinine increased
8%
Stomatitis
8%
Malaise
8%
Muscular weakness
8%
Haematuria
7%
Myalgia
7%
Punctate keratitis
7%
Tachycardia
7%
Hypotension
7%
Gastrooesophageal reflux disease
7%
Lymphocyte count decreased
6%
Blepharitis
6%
Dysphagia
6%
Rhinorrhoea
6%
Pneumonia
6%
Blood alkaline phosphatase increased
6%
Cellulitis
6%
Musculoskeletal pain
6%
Dysphonia
6%
Oral candidiasis
6%
Hyperuricaemia
6%
Hypophosphataemia
6%
Asthenia
6%
Gait disturbance
6%
Hypertension
6%
Skin exfoliation
6%
White blood cell count decreased
5%
Dysuria
5%
Rash macular
5%
Abdominal pain upper
5%
Headache
4%
Chills
4%
Febrile neutropenia
3%
Sepsis
3%
Acute kidney injury
3%
Infusion related reaction
3%
Hypoalbuminaemia
3%
Abdominal distension
3%
Paraesthesia
3%
Anxiety
3%
Pollakiuria
2%
Spinal cord compression
2%
Hypoxia
2%
Pneumonia aspiration
2%
Deep vein thrombosis
2%
Hyperkalaemia
2%
Hypercalcaemia
2%
Pulmonary embolism
2%
Transitional cell carcinoma metastatic
2%
Urinary tract obstruction
2%
Rash vesicular
2%
Colitis
2%
Infusion site extravasation
2%
Acute respiratory failure
1%
Delirium
1%
Urinary tract infection staphylococcal
1%
Drug eruption
1%
Pleural effusion
1%
Palpitations
1%
Incarcerated hernia
1%
Device related infection
1%
Neutrophil count decreased
1%
Infection
1%
Compression fracture
1%
Aortic stenosis
1%
Cancer pain
1%
Transitional cell carcinoma
1%
Interstitial lung disease
1%
Embolism
1%
Wound
1%
Hypoglycaemia
1%
Hypomagnesaemia
1%
Colon cancer
1%
Encephalopathy
1%
Confusional state
1%
Stevens-Johnson syndrome
1%
Gastrointestinal haemorrhage
1%
Enterocolitis
1%
Cardiac disorder
1%
Large intestinal obstruction
1%
Odynophagia
1%
Small intestinal obstruction
1%
Bile duct stone
100%
80%
60%
40%
20%
0%
Study treatment Arm
Enfortumab Vedotin - Cohort 1
Enfortumab Vedotin - Cohort 2

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment: all patientsExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Enfortumab vedotin
2017
Completed Phase 2
~240

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for prostate cancer include androgen deprivation therapy (ADT), which reduces androgen levels to slow cancer growth; chemotherapy, which uses drugs to kill rapidly dividing cancer cells; and immunotherapy, which boosts the body's immune system to fight cancer. Targeted therapies, such as Enfortumab Vedotin, an antibody-drug conjugate targeting Nectin-4, deliver cytotoxic agents directly to cancer cells, minimizing damage to normal cells. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on the cancer's characteristics and the patient's overall health, potentially improving outcomes and reducing side effects.

Find a Location

Who is running the clinical trial?

Astellas Pharma IncIndustry Sponsor
695 Previous Clinical Trials
233,274 Total Patients Enrolled
36 Trials studying Prostate Cancer
8,642 Patients Enrolled for Prostate Cancer
University of UtahLead Sponsor
1,136 Previous Clinical Trials
1,791,271 Total Patients Enrolled
7 Trials studying Prostate Cancer
5,292 Patients Enrolled for Prostate Cancer
Umang Swami, MDPrincipal InvestigatorHuntsman Cancer Institute
2 Previous Clinical Trials
65 Total Patients Enrolled

Media Library

Enfortumab Vedotin (Antibody-Drug Conjugate) Clinical Trial Eligibility Overview. Trial Name: NCT04754191 — Phase 2
Prostate Cancer Research Study Groups: Treatment: all patients
Enfortumab Vedotin (Antibody-Drug Conjugate) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04754191 — Phase 2
~8 spots leftby Sep 2025