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Rollover Study in Subjects With Metastatic Solid Tumors Benefiting From Therapy With Sacituzumab Govitecan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04319198
Recruitment Status : Not yet recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Immunomedics, Inc.

Brief Summary:

Rollover study designed to evaluate long-term safety in subjects with metastatic solid tumors that are benefiting from continued treatment with sacituzumab govitecan.

Patients currently receiving, clinically benefiting from, and tolerating sacituzumab govitecan in an Immunomedics-sponsored parent study planned for closure will be considered for enrollment.


Condition or disease Intervention/treatment Phase
Solid Tumor Metastatic Cancer Drug: Sacituzumab Govitecan Phase 3

Detailed Description:
This is an open-label, longitudinal cohort, rollover study. Eligible participants will receive sacituzumab govitecan therapy at the dose they were receiving in the parent study. No participant will receive more than 10 mg/kg dose of sacituzumab govitecan. Treatment with sacituzumab govitecan will be uninterrupted as eligible participants rollover/transition from the parent study to the rollover study. Participants may continue to receive sacituzumab govitecan until they experience toxicity, disease progression, loss of clinical benefit, lost to follow-up, or upon participant withdrawal of consent or Sponsor termination of the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Rollover Study to Evaluate Long-Term Safety in Subjects With Metastatic Solid Tumors That Are Benefiting From Continuation of Therapy With Sacituzumab Govitecan
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024

Arm Intervention/treatment
Experimental: Sacituzumab Govitecan
Sacituzumab govitecan is a Trop-2-directed Antibody Drug Conjugate where the antibody, hRS7, is attached to SN-38. SN-38 is the active metabolite of irinotecan (CPT-11).
Drug: Sacituzumab Govitecan
intravenous infusion administered on Days 1 and 8 of 21-day treatment cycles
Other Name: IMMU-132




Primary Outcome Measures :
  1. Long-term Safety [ Time Frame: Through study completion, an average of 3 years ]
    Number of participants with treatment-related AEs as assessed by CTCAE v 5.0



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Receiving ongoing treatment with sacituzumab govitecan in an Immunomedics-sponsored study that is closing
  • Continuing to receive clinical benefit from sacituzumab govitecan therapy

Exclusion Criteria:

  • Women who are pregnant or lactating
  • Initiated therapy with another cancer therapeutic agent since receiving last dose of study drug on the Immunomedics-sponsored study in which they participated
  • Experienced a toxicity from sacituzumab govitecan that resulted in permanent discontinuation of therapy
  • Have other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319198


Contacts
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Contact: Medical Information 888-983-4668 medinfo@immunomedics.com

Sponsors and Collaborators
Immunomedics, Inc.
Investigators
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Study Director: Trishna Goswami, MD Immunomedics, Inc.
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Responsible Party: Immunomedics, Inc.
ClinicalTrials.gov Identifier: NCT04319198    
Other Study ID Numbers: IMMU-132-14
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Immunomedics, Inc.:
Sacituzumab Govitecan
IMMU-132
ADC
Antibody-Drug Conjugate
Trop-2
SN-38
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms
Neoplastic Processes
Pathologic Processes