SC-004 Alone or With ABBV-181 in Subjects With Epithelial Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancers

Stopped early · Phase 1

Conditions studied: Cancer

In brief

This is a two-part study consisting of Part A (dose regimen finding) followed by Part B (dose expansion). Part A (dose regimen finding) will allow definition of the maximum tolerated dose (MTD) through dose escalation and possible dose interval modification. In Part B (dose expansion), potential therapeutic doses may be studied with SC-004 as monotherapy and SC-004 in combination with ABBV-181 in disease-specific cohorts.

Key facts

Study ID

NCT03138408

Run by

AbbVie

People needed

24

Starts

2017-06-14

Expected to finish

2019-05-02

Last updated by the study team

2019-05-14

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed advanced malignancy defined as any of the following tumors for which no further standard or curative therapy exists or is considered appropriate by the Investigator:
• Epithelial ovarian cancer, including fallopian tube cancer or primary peritoneal cancer, of high-grade serous histology, with platinum refractory or resistant disease after prior treatment with at least one platinum-based chemotherapeutic regimen. In Part B (dose expansion), subjects may have received no more than 3 lines of systemic cytotoxic chemotherapy.
• Note, the line of therapy limit does not apply to the biopsy substudy cohorts.
• Metastatic or advanced endometrial carcinoma previously treated with at least 1 platinum-based chemotherapeutic regimen.
• Eastern Cooperative Oncology Group (ECOG) 0-1.
• Adequate hematologic, hepatic, and renal function.

You may not qualify if…

• Participants with prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug.

Where it is running

• University of Alabama /ID# 202249 — Birmingham, Alabama, United States
• Highlands Oncology Group /ID# 209165 — Fayetteville, Arkansas, United States
• City of Hope /ID# 202493 — Duarte, California, United States
• University of Chicago /ID# 200735 — Chicago, Illinois, United States
• Henry Ford Health System /ID# 202480 — Detroit, Michigan, United States
• Mayo Clinic - Rochester /ID# 200732 — Rochester, Minnesota, United States
• Washington University School /ID# 164091 — St Louis, Missouri, United States
• The Ohio State University - Columbus /ID# 164089 — Columbus, Ohio, United States
• Univ Oklahoma HSC /ID# 164090 — Oklahoma City, Oklahoma, United States
• Tennessee Oncology-Nashville Centennial /ID# 164088 — Nashville, Tennessee, United States
• MD Anderson Cancer Center /ID# 200048 — Houston, Texas, United States
• Huntsman Cancer Institute /ID# 209164 — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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