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Phase I/II Study of IMMU-132 in Patients With Epithelial Cancers

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. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01631552
Recruitment Status : Active, not recruiting
First Posted : June 29, 2012
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Immunomedics, Inc.

Tracking Information
First Submitted Date  ICMJE June 26, 2012
First Posted Date  ICMJE June 29, 2012
Last Update Posted Date April 8, 2019
Study Start Date  ICMJE February 2013
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 27, 2018)
Safety (adverse events, change in lab values) [ Time Frame: During treatment, at the final evaluation and at follow up 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 27, 2012)
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.
Change History Complete list of historical versions of study NCT01631552 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 27, 2018)
Efficacy (change in tumor measurements) [ Time Frame: Efficacy will be assessed every 8 weeks during treatment and then every 12 weeks after treatment ]
Efficacy will be evaluated from CT scans (or MRI studies), using RECIST 1.1 to classify tumor response, time to onset of objective response, duration of objective response, and time to progression. Efficacy will be assessed every 8 weeks until the end of treatment or progression of disease and every 12 weeks at the follow up, over an average of 6 months.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2012)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase I/II Study of IMMU-132 in Patients With Epithelial Cancers
Official Title  ICMJE A Phase I/II Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients With Epithelial Cancers
Brief Summary The primary objective is to evaluate the safety and tolerability of IMMU-132 as a single agent administered in 3-week treatment cycles until unacceptable progression or toxicity, in previously treated patients with advanced epithelial cancer. In Phase II, the primary objective is the evaluation of the safety and efficacy of IMMU-132 administered in 3-week treatment cycles at a dose selected in Phase I, while the secondary objectives include pharmacokinetics and immunogenicity.
Detailed Description This is a Phase I/II, open-label study of IMMU-132 in previously treated patients with advanced epithelial cancers. Patients receive IMMU-132 administered once-weekly for the first 2 weeks of 3-week treatment cycles. Treatment cycles will continue until unacceptable toxicity or progression of disease. Both safety and efficacy will be assessed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gastric Adenocarcinoma
  • Esophageal Cancer
  • Hepatocellular Carcinoma
  • Non-small Cell Lung Cancer
  • Small Cell Lung Cancer
  • Ovarian Epithelial Cancer
  • Carcinoma Breast Stage IV
  • Hormone-refractory Prostate Cancer
  • Head and Neck Cancers- Squamous Cell
  • Renal Cell Cancer
  • Urinary Bladder Neoplasms
  • Cervical Cancer
  • Endometrial Cancer
  • Follicular Thyroid Cancer
  • Glioblastoma Multiforme
  • Triple Negative Breast Cancer
  • Pancreatic Cancer
Intervention  ICMJE Drug: IMMU-132
IMMU-132 is administered on days 1 & 8 of 3 week treatment cycles.
Other Names:
  • hRS7-SN38
  • Sacituzumab Govitecan
Study Arms  ICMJE Experimental: IMMU-132
IMMU-132 (hRS7-SN38) is an Antibody Drug Conjugate where the antibody, hRS7 is attached to SN38. SN38 is the active metabolite of irinotecan (CPT-11).
Intervention: Drug: IMMU-132
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 27, 2018)
500
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2012)
36
Estimated Study Completion Date  ICMJE September 2019
Estimated Primary Completion Date June 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female patients, ≥ 18 years of age, able to understand and give written informed consent.
  • Histologically or cytologically confirmed epithelial cancer of one of the following types:
  • Gastric adenocarcinoma (GC)
  • Esophageal cancer (EC)
  • Hepatocellular carcinoma (HCC)
  • Non-small-cell lung cancer (NSCLC)
  • Small-cell lung cancer (SCLC)
  • Epithelial ovarian cancer (EOC)
  • Cervical Cancer
  • Endometrial Cancer
  • Triple-negative breast cancer [With Amendment 10, these patients need to have unequivocal TNBC histology (ER-/PR-/HER2-) per ASCO/CAP guidelines, based on most recently analyzed biopsy, and must have had at least 2 prior therapies for metastatic disease, including prior taxane (any setting). Chemotherapy, biological or targeted or immunotherapy agents will count as qualifying prior therapies, but not hormonal or anti-HER2 agents (either given prior to achieving triple negative status or for any other reason).]
  • Non-triple-negative breast cancer
  • Follicular thyroid cancer
  • Glioblastoma multiforme (GBM)
  • Hormone-refractory prostate cancer (HRPC)
  • Head and neck cancers- squamous cell (SCCHN)
  • Renal cell cancer (clear cell) (RCC)
  • Urothelial cancer

(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 (except for patients with GBM).
  • Refractory to or relapsed after at least one prior standard therapeutic regimen
  • Adequate performance status (ECOG 0 or 1)
  • Expected survival ≥ 6 months.
  • Measurable disease by CT or MRI.
  • At least 2 weeks beyond treatment (chemotherapy, investigational drugs including small molecular inhibitors, immunotherapy and/or radiation therapy) or major surgery and recovered from all acute toxicities to Grade 1 or less (except alopecia).
  • At least 2 weeks beyond high dose systemic corticosteroids (however, low dose corticosteroids < 20 mg prednisone or equivalent daily are permitted).
  • Adequate hematology without ongoing transfusional support (hemoglobin > 9 g/dL, ANC > 1,500 per mm3, platelets > 100,000 per mm3).
  • Adequate renal and hepatic function (creatinine ≤ 2.0 x IULN, bilirubin ≤ 1.5 IULN, AST and ALT ≤ 3.0 x IULN or 5 x IULN if know liver metastases).
  • Otherwise, all toxicity at study entry ≤ Grade 1.

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.
  • Patients with brain metastases can be enrolled only if treated, non-progressive brain metastases and off high-dose steroids (>20 mg prednisone or equivalent) for at least 4 weeks.
  • Presence of bulky disease (defined as any single mass > 7 cm in its greatest dimension). Patients with a mass over 7 cm, but otherwise eligible, may be considered for enrollment after discussion and approval with the medical monitor.
  • 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.
  • Prior history of clinically significant bleeding, intestinal obstruction, or GI perforation within 6 months of initiation of study treatment.
  • Infection requiring intravenous antibiotic use within 1 week.
  • history of an anaphylactic reaction to irinotecan or ≥ Grade 3 GI toxicity to prior irinotecan,
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01631552
Other Study ID Numbers  ICMJE IM-T-IMMU-132-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Immunomedics, Inc.
Study Sponsor  ICMJE Immunomedics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Aditya Bardia, MD Massachusetts General Hospital
PRS Account Immunomedics, Inc.
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP