Clinical Trial 18391

Cancer Type: Thoracic

Study Type: Treatment
Phase of Study: Phase II


    Study Title

    A Phase I/II Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients with Epithelial Cancer


    The purpose of this study is to test the safety of IMMU-132 at different dose levels. Investigators want to find out what effects, good and/or bad, it has on participants and their advanced epithelial cancer.


    Primary Objective: The primary objective is to evaluate the safety and tolerability of IMMU-132 as a single agent administered in 3-week treatment cycles for up to 8 cycles, in previously treated patients with advanced epithelial cancer. Dose escalation in Phase I (completed) was intended to determine a maximum acceptable dose and select cancer types for continued expanded study in Phase II. Phase II continues enrollment with dose levels and cancers selected based upon Phase I results. Secondary Objectives: The secondary objectives are to obtain initial data concerning pharmacokinetics, immunogenicity, and efficacy with this dosing regimen.

    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: Colorectal; Gastric adenocarcinoma; Esophageal cancer; Hepatocellular carcinoma; Non-small cell lung cancer; Small cell lung cancer; Ovarian epithelial cancer; Cervical Cancer; Endometrial Cancer; Triple-negative breast cancer (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; Hormone-refractory prostate cancer; Pancreatic ductal adenocarcinoma; Head and neck cancers- squamous cell; Renal cell cancer (clear cell); Urothelial cancers; Glioblastoma multiforme; Follicular thyroid cancer.
  • Stage IV (metastatic) disease.
  • 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 > Adequate hematology without ongoing transfusional support.
  • Adequate renal and hepatic function.

  • 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.
  • 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.