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History of Changes for Study: NCT01631552
Ph I Dose Escalation Study of Antibody-drug Conjugate IMMU-132 in Patients With Advanced Epithelial Cancers
Latest version (submitted August 10, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 27, 2012 None (earliest Version on record)
2 March 27, 2013 Recruitment Status, Contacts/Locations, Study Status and Oversight
3 December 6, 2013 Contacts/Locations, Outcome Measures, Arms and Interventions, Study Design, Conditions, Study Description, Study Status, Study Identification and Eligibility
4 January 22, 2014 Study Status and Contacts/Locations
5 March 7, 2014 Contacts/Locations, Study Status and Eligibility
6 January 14, 2015 Study Status, Contacts/Locations, Conditions, Study Description, Eligibility, Outcome Measures, Arms and Interventions and Study Design
7 September 3, 2015 Contacts/Locations, Study Status, Conditions, Study Description and Eligibility
8 October 20, 2015 Contacts/Locations and Study Status
9 December 9, 2015 Contacts/Locations and Study Status
10 May 31, 2016 Contacts/Locations and Study Status
11 July 29, 2016 Contacts/Locations and Study Status
12 September 20, 2016 Contacts/Locations and Study Status
13 June 13, 2017 Contacts/Locations, Study Status and Conditions
14 April 23, 2018 Recruitment Status, Study Status and Contacts/Locations
15 November 9, 2018 Study Status
16 November 27, 2018 Outcome Measures, Contacts/Locations, Conditions, Study Description, Oversight, Eligibility, Arms and Interventions, Study Design and Study Status
17 April 5, 2019 Study Status
18 November 20, 2019 Study Status and Study Design
19 August 12, 2020 Study Status
20 September 8, 2020 Recruitment Status, Study Status
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Results Submission Events
21 March 10, 2021 Study Status, Arms and Interventions, Outcome Measures, Contacts/Locations, Study Identification, References, Study Design, Conditions, Study Description, Document Section, Results and Eligibility
22 August 10, 2021 Adverse Events, Outcome Measures, Arms and Interventions, More Information, Participant Flow, Study Status, Study Description, Study Identification, Baseline Characteristics and Contacts/Locations
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Study NCT01631552
Submitted Date:  June 27, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: IM-T-IMMU-132-01
Brief Title: Ph I Dose Escalation Study of Antibody-drug Conjugate IMMU-132 in Patients With Advanced Epithelial Cancers
Official Title: A Phase I Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients With Epithelial Cancer
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2012
Overall Status: Not yet recruiting
Study Start: October 2012
Primary Completion: December 2014 [Anticipated]
Study Completion: June 2015 [Anticipated]
First Submitted: June 26, 2012
First Submitted that
Met QC Criteria:
June 27, 2012
First Posted: June 29, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
June 27, 2012
Last Update Posted: June 29, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Gilead Sciences
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: The purpose of this study is to test the safety of IMMU-132 at different dose levels. IMMU-132 targets the TROP-2 antigen which is expressed on a variety of cancers and is also known as EGP-1 (epithelial glycoprotein-1). The antibody, RS7, is attached to SN38, which is the active metabolite of irinotecan (CPT-11).
Detailed Description: IMMU-132 will be administered on days 1 & 8 of a 21-day treatment cycle and up to 8 cycles may be administered. Treatment will continue until unacceptable toxicity or progression of disease. Both safety and efficacy will be assessed.
Open or close this module Conditions
Conditions: Advanced Epithelial Cancers
Ovarian Cancer
Prostate Cancer
Lung Cancer
Breast Cancer
Gastric Cancer
Colorectal Cancer
Pancreatic Cancer
Hepatocellular Cancer
Keywords: advanced epithelial cancers
including ovarian
prostate
lung
breast
gastric
colorectal
pancreatic
hepatocellular cancers
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 36 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: IMMU-132
IMMU-132 is an antibody drug conjugate where the antibody, RS7 is attached to SN38. SN38 is the active metabolit of irinotecan (CPT-11).
Drug: IMMU-132
IMMU-132 is an antibody-drug conjugate which will be administered on days 1 & 8 of 3 week treatment cycles. Up to 8 cycles will be given.
Other Names:
  • RS7-SN38
  • TROP-2
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Safety
[ Time Frame: during treatment and the change at the final evaluation after treatment ]

Safety will be assessed by monitoring the patient for adverse events, monitoring the change in lab values during and after treatment compared to baseline over an average of 6 months.
Secondary Outcome Measures:
1. Efficacy
[ Time Frame: Efficacy will be assessed at 6-8 weeks during treatment and at the end of treatment ]

Efficacy will be assessed by measuring the change in tumor measurements based on CT scan changes from baseline to 6-8 weeks during treatment and the changes from these 2 timepoints until the end of treatment, over an average of 6 months.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Male or female patients, >18 years of age, able to understand and give written informed consent.
  • Histologically or cytologically confirmed epithelial adenocarcinoma of one of the following types:
  • Breast cancer (BC)
  • Colorectal (CRC)
  • Gastric adenocarcinoma (GC)
  • Hepatocellular carcinoma (HCC)
  • Non-small cell lung cancer (NSCLC)
  • Ovarian epithelial cancer (OEC)
  • Pancreatic ductal adenocarcinoma (PDC)
  • Prostate adenocarcinoma (PC) (Note: Confirmation of Trop-2 expression by immunohistology or other means is not required, but the Sponsor will request tissue specimens from archived materials for determination of Trop-2 expression.)
  • Stage IV (metastatic) disease.
  • Previously treated with at least one prior therapeutic regimen, but no more than 3 prior chemotherapy regimens.
  • Adequate performance status (ECOG 0 or 1) (Appendix 1)
  • Expected survival > 6 months.
  • Measurable disease by CT or MRI.
  • At least 2 weeks beyond treatment (chemotherapy, immunotherapy and/or radiation therapy) or major surgery and recovered from all acute toxicities.
  • At least 2 weeks beyond corticosteroids (however, low dose corticosteroids < 20 mg prednisone or equivalent daily are permitted).
  • Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, ANC > 2,000 per mm3, platelets > 150,000 per mm3).
  • Adequate renal and hepatic function (creatinine ≤ 2.0 x IULN, bilirubin ≤ IULN, AST and ALT ≤ 3.0 x IULN or 5 x IULN if know liver metastases).
  • Otherwise, all toxicity at study entry < Grade 1 by NCI CTC v4.0.

Exclusion Criteria:

  • Women who are pregnant or lactating.
  • Women of childbearing potential and fertile men unwilling to use effective contraception during study until conclusion of 12-week post-treatment evaluation period.
  • Patients with Gilbert's disease.
  • Known CNS metastatic disease.
  • Presence of bulky disease (defined as any single mass >5 cm in its greatest dimension).
  • Patients with active ≥ grade 2 anorexia, nausea or vomiting, and/or signs of intestinal obstruction.
  • Patients with non-melanoma skin cancer or carcinoma in situ of the cervix are eligible, while patients with other prior malignancies must have had at least a 3-year disease-free interval.
  • Patients known to be HIV positive, hepatitis B positive, or hepatitis C positive.
  • Known history of unstable angina, MI, or CHF present within 6 months or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy,
  • Known history of clinically significant active COPD, or other moderate-to-severe chronic respiratory illness present within 6 months.
  • Infection requiring intravenous antibiotic use within 1 week.
  • 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.
Open or close this module Contacts/Locations
Central Contact Person: Jonathan Rojo
Telephone: 973-605-8200
Email: jrojo@immunomedics.com
Central Contact Backup: Fran Bozza
Telephone: 973-605-8200
Study Officials: William Wegener, MD, PhD
Study Chair
Gilead Sciences
Locations: United States, New York
Weill Cornell/New York Presbyterian Hospital
New York, New York, United States, 10021
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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