Sacituzumab Govitecan in Patients With Metastatic Castration-Resistant Prostate Cancer Progressing on Second Generation AR-Directed Therapy

NCT03725761 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 7 other identifiers: UW18043P30CA014520A534260SMPH\MEDICINE\HEM-ONCNCI-2018-02551Protocol Version 5/12/20222018-0857
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 3

Brief Summary

This study will investigate the safety and efficacy of Sacituzumab Govitecan in patients with metastatic castration-resistant prostate cancer progressing on second generation androgen receptor (AR) directed therapy (e.g., enzalutamide, darolutamide, apalutamide and/or abiraterone).

Conditions

Prostate Cancer

Keywords

Prostate

Outcome Measures

Primary Outcomes (2)

• PSA Response Rate

  Subjects who achieve ≥50% PSA decline at or before 9 weeks of therapy with Sacituzumab Govitecan (IMMU-132) are considered to have responded. PSA responses will be analyzed by descriptive statistics and summarized in tabular format (frequency tables). The overall PSA response rate will be reported along with the corresponding 95% confidence interval which will be constructed using the Wilson score method.

  up to 9 weeks

• 6-Month Progression Free Survival Rate

  Proportion of participants remaining alive and progression free (using Prostate Cancer Working Group 2 (PCWG2) criteria) 6 months from time of starting treatment as estimated by the Kaplan-Meier method.

  6 months

Secondary Outcomes (4)

• Median Progression Free Survival Rate

  Up to 2 years from start of treatment

• Radiologic Response Rate

  up to 2 years from start of treatment

• Median Overall Survival

  Up to 2 years from start of treatment

• Toxicity Rates (Grade 2, Grade 3, Grade 4, Grade ≥ 2, Grade ≥ 3, Etc.)

  Up to 9 weeks from start of treatment

Study Arms (1)

Sacituzumab Govitecan Treatment

EXPERIMENTAL

Subjects enrolled in this study will receive Sacituzumab Govitecan in addition to their single agent Androgen Receptor Signaling Inhibitors (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.

Drug: Sacituzumab Govitecan

Interventions

Sacituzumab Govitecan DRUG

Sacituzumab Govitecan is a novel Antibody Drug Conjugate (ADC) based on a humanized anti-Trop-2 antibody (hRS7) conjugated to SN-38 payload.

Also known as: IMMU-132

Sacituzumab Govitecan Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented histological or cytological evidence of adenocarcinoma of the prostate
• Documented metastatic disease on bone scan and/or CT scans
• Currently receiving enzalutamide, darolutamide, apalutamide and/or abiraterone. Subjects who have received combination enzalutamide/abiraterone or combination apalutamide/abiraterone as part of clinical trials are allowed but will need to be receiving only a single agent ARSI at the time of study enrollment. Subjects who have received any other therapeutic investigational product directed towards the AR or androgen biosynthesis are allowed. Prior treatment with first-generation AR antagonists (i.e., bicalutamide, nilutamide, flutamide) before second generation AR-directed therapy is allowed.
• Demonstrated disease progression while on enzalutamide, darolutamide, apalutamide, and/or abiraterone. Progressive disease is defined by one or more of the following:
• A rise in prostate specific antigen (PSA) on two successive determinations at least one week apart and PSA level ≥2 ng/mL
• Soft-tissue progression defined by RECIST 1.1
• Bone disease progression defined by Prostate Cancer Working Group 2 (PCWG2) with ≥2 new lesions on bone scan
• A minimum serum PSA level of ≥2 ng/mL that is rising based on the PCWG2 criteria
• ≥18 y ears of age
• Castrate levels of testosterone (\<50 ng/dL \[1.74 nmol/L\])
• Undergone orchiectomy, or have been on Luteinizing hormone-releasing hormone (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
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
• Normal organ function with acceptable initial laboratory values within 30 days of study treatment start:
• White Blood Cell Count (WBC) greater than or equal to 3000/μl
• Absolute Neutrophil Count (ANC) greater than or equal to 1000/μl

You may not qualify if:

• Received prior cytotoxic chemotherapy such as docetaxel, cabazitaxel or platinum chemotherapy for metastatic prostate cancer, castration sensitive or castration resistant, within two years prior to study entry. Neoadjuvant chemotherapy is allowed.
• Completed sipuleucel-T (Provenge ®) treatment within 30 days of study treatment start.
• Received any therapeutic investigational agent within 2 weeks of study treatment start.
• Received palliative radiotherapy within 4 weeks of study treatment start.
• Received herbal products or alternative therapies that may decrease PSA levels or that may have hormonal anti-prostate cancer activity (e.g., saw palmetto, PC-SPES, PC-HOPE, St. John's wort, selenium supplements, grape seed extract, etc.) within 4 weeks of study treatment start or plans to initiate treatment with these products/alternative therapies during the entire duration of the study.
• Active central nervous system (CNS) metastases from prostate cancer. Subjects with treated epidural disease are eligible to enroll. Subjects with treated brain metastases can be included as long as \>4 weeks have elapsed since last treatment (radiotherapy or surgery) for brain metastases, the subject is neurologically and radiographically stable, and is not receiving corticosteroids for brain metastases. Subjects with untreated brain metastases are excluded. Brain imaging (CT or MRI) is not required at baseline if brain metastases are not clinically suspected.
• A history within the last 3 years of another invasive malignancy (excluding non-melanoma skin cancer).
• A QTcF interval of \>470 msec on the initial Screening ECG; if the Screening ECG QTcF interval is \>470 msec, then it may be repeated two more times, and if the mean QTcF of the 3 ECGs is ≤470 msec, the subject may be enrolled.
• A history of clinically significant cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation, torsades de pointes and second degree or third degree atrioventricular heart block without a permanent pacemaker in place. Subjects with resolved or rate-controlled atrial fibrillation/atrial flutter are allowed.
• NYHA Class III or IV congestive heart failure, unstable angina, myocardial infarction/acute coronary syndrome within the preceding 6 months.
• Diabetes mellitus with more than 2 episodes of diabetic ketoacidosis in the 12 months preceding study treatment start.
• Inadequately controlled hypertension (defined as blood pressure \>150mmHg systolic and/or \>100 mmHg diastolic despite antihypertensive medication) or any history of hypertensive crisis or hypertensive encephalopathy.
• History of loss of consciousness or transient ischemic attack within 12 months before study treatment start.
• Known active HIV, Hepatitis B, or Hepatitis C infections.
• Any other medical, psychiatric, or social condition, including substance abuse, which in the opinion of the Investigator would preclude safe participation in the study.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator
• Gilead Sciences: collaborator

Study Sites (3)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

sacituzumab govitecan

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Joshua M Lang, MD, MS
• Organization: Wisconsin Institutes for Medical Research

jmlang@medicine.wisc.edu

(608) 265-8131

Study Officials

• Joshua Lang, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 31, 2018
• Study Start: October 24, 2018
• Primary Completion: April 18, 2024
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 13, 2025
• Results First Posted: April 24, 2025

Record last verified: 2025-05

Locations

US (3)