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Antibody-Drug Conjugate

Sacituzumab Govitecan for Metastatic Castration-Resistant Prostate Cancer

Phase 2

Waitlist Available

Led By Joshua Lang, MD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Undergone orchiectomy, or have been on LHRH agonists or antagonists, for at least 3 months prior to study treatment start. Subjects on LHRH agonists/antagonists must remain on these agents for the duration of the study

Normal organ function with acceptable initial laboratory values within 30 days of study treatment start: WBC ≥3000/μl, ANC ≥1000/μl, Platelet count ≥100,000/μl, HGB ≥9 g/dL, Adequate hepatic function as evidenced by AST/ALT levels <3X the ULN and bilirubin levels of <2.0 mg/dl, Adequate renal function as evidenced by serum creatinine of <2.0 mg/dL

Must not have

Known active HIV, Hepatitis B, or Hepatitis C infections

Received herbal products or alternative therapies that may decrease PSA levels or that may have hormonal anti-prostate cancer activity within 4 weeks of study treatment start or plans to initiate treatment with these products/alternative therapies during the entire duration of the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years from start of treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a new cancer drug, IMMU-132, on men with prostate cancer that has spread and is resistant to hormone therapy.

Who is the study for?

Men over 18 with advanced prostate cancer that's resistant to hormone therapy and has worsened despite treatment like enzalutamide or abiraterone. They should have no other recent cancers, not had certain treatments recently, and must be in fairly good health with stable heart conditions. Participants need a biopsy available from their cancer and agree to use two forms of birth control if applicable.

What is being tested?

The trial is testing Sacituzumab Govitecan for safety and effectiveness in men whose prostate cancer has spread and isn't responding to second-generation AR-directed therapies. The study includes those who've progressed on drugs such as enzalutamide or abiraterone.

What are the potential side effects?

Sacituzumab Govitecan can cause side effects including nausea, diarrhea, fatigue, hair loss, lower blood cell counts increasing infection risk, allergic reactions during infusion, liver problems (elevated liver enzymes), and potential harm to an unborn baby.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had surgery to remove my testicles or have been on hormone therapy for prostate cancer for at least 3 months.

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My blood, liver, and kidney tests are within normal ranges.

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My prostate cancer was confirmed by a lab test.

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I am 18 years old or older.

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I am fully active or can carry out light work.

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My cancer has worsened despite treatment with specific prostate cancer medications.

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My scans show cancer has spread to my bones or other areas.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have active HIV, Hepatitis B, or Hepatitis C infections.

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I haven't used herbal or alternative therapies that affect PSA levels or fight prostate cancer in the last 4 weeks.

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I received palliative radiotherapy less than 4 weeks ago.

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My blood pressure is not well controlled, or I've had a severe hypertension crisis before.

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I have not had any cancer other than non-melanoma skin cancer in the past 3 years.

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I have diabetes and had more than 2 ketoacidosis episodes in the last year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years from start of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years from start of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years from start of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

6-Month Median Progression Free Survival

PSA response rate

Secondary study objectives

Median Overall Survival

Median Progression Free Survival Rate

Radiologic Response Rate

+1 more

Side effects data

From 2020 Phase 3 trial • 529 Patients • NCT02574455

40%

Fatigue

30%

Nausea

27%

Anaemia

25%

Neutropenia

23%

Constipation

21%

Decreased appetite

20%

Neutrophil count decreased

18%

Cough

18%

Dyspnoea

17%

Diarrhoea

16%

Alopecia

16%

Vomiting

13%

Hypokalaemia

13%

Headache

13%

Back pain

13%

Asthenia

12%

Pyrexia

12%

Aspartate aminotransferase increased

11%

Oedema peripheral

11%

Neuropathy peripheral

10%

Alanine aminotransferase increased

10%

White blood cell count decreased

Urinary tract infection

Myalgia

Pain in extremity

Platelet count decreased

Arthralgia

Dizziness

Abdominal pain

Weight decreased

Mucosal inflammation

Lymphocyte count decreased

Bone pain

Hypomagnesaemia

Hypertension

Thrombocytopenia

Stomatitis

Insomnia

Pain

Rash

Blood alkaline phosphatase increased

Hyperglycaemia

Oropharyngeal pain

Hypophosphataemia

Anxiety

Abdominal pain upper

Breast pain

Upper respiratory tract infection

Musculoskeletal chest pain

Dysgeusia

Lymphoedema

Pruritus

Pleural effusion

Gastrooesophageal reflux disease

Chills

Nasopharyngitis

Hypocalcaemia

Febrile neutropenia

Sepsis

Pneumonia

Nasal congestion

Dyspnoea exertional

Dry skin

Rash maculo-papular

Pericardial effusion

Pulmonary embolism

Respiratory failure

Cellulitis

100%

80%

60%

40%

20%

Study treatment Arm

Treatment of Physician's Choice (TPC)

Sacituzumab Govitecan

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: Sacituzumab Govitecan TreatmentExperimental Treatment1 Intervention

Subjects enrolled in this study will receive Sacituzumab Govitecan in addition to their single agent ARSI as treatment for Castrate-Resistant Prostate Cancer. Dose will be calculated per protocol in milligrams based on the subject's body weight at the beginning of each cycle or more frequently if weight changes \>10%. Subjects will be treated on days 1 and 8 in a 21-day cycle, minimum 3 cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sacituzumab Govitecan

2019

Completed Early Phase 1

~30

0 / 13Eligibility criteria met