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

An Open Label, Phase 1 Study of SC-004 as Monotherapy and in Combination With ABBV-181 in Subjects With Epithelial Ovarian, Including Fallopian Tube and Primary Peritoneal and Endometrial Cancers

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.

Study Overview

• Status: Terminated
• Conditions: Cancer
• Intervention / Treatment: Drug: ABBV-181; Drug: SC-004

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama /ID# 202249
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703-4005
      • Highlands Oncology Group /ID# 209165
  • California
    • Duarte, California, United States, 91010
      • City of Hope /ID# 202493
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago /ID# 200735
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System /ID# 202480
  • Minnesota
    • Rochester, Minnesota, United States, 55905-0001
      • Mayo Clinic - Rochester /ID# 200732
  • Missouri
    • Saint Louis, Missouri, United States, 63108
      • Washington University School /ID# 164091
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University - Columbus /ID# 164089
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Univ Oklahoma HSC /ID# 164090
  • Tennessee
    • Nashville, Tennessee, United States, 37203-1632
      • Tennessee Oncology-Nashville Centennial /ID# 164088
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center /ID# 200048
  • Utah
    • Salt Lake City, Utah, United States, 84112-5500
      • Huntsman Cancer Institute /ID# 209164

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SC-004	Drug: SC-004; Intravenous
Experimental: SC-004 and ABBV-181	Drug: ABBV-181; Intravenous; Drug: SC-004; Intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with dose-limiting toxicities (DLT)	DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.	Minimum first cycle of dosing (21-day cycles)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observed plasma concentrations at trough (Ctrough)	Observed plasma concentrations at trough.	Approximately 1 year
Overall Survival (OS)	OS is defined as the time from the subject's first dose date to death due to any cause.	Approximately 2 years
Objective Response Rate (ORR)	ORR is defined as the proportion of subjects with complete response or partial response (CR+PR).	Approximately 2 years
Terminal half life (T1/2)	Terminal half life (T1/2).	Approximately 1 year
Maximum observed serum concentration (Cmax)	Maximum observed serum concentration.	Approximately 1 year
Time to Cmax (Tmax)	Time to Cmax.	Approximately 1 year
Clinical Benefit Rate (CBR)	CBR is defined as the proportion of subjects with an objective response or stable disease (CR+PR+SD).	Approximately 2 years
Progression Free Survival (PFS)	PFS time is defined as the time from the subject's first dose of study drug (Day 1) to either the subject's disease progression or death due to any cause, whichever occurs first. Under the situation that neither event occurs, the PFS time will be censored at the date of last tumor assessment. Subjects lacking an evaluation of tumor response after their first dose of study treatment will have their event time censored at Day 1.	Approximately 2 years
Duration of Response (DOR)	DOR is defined as the time from the subject's initial objective response (CR or PR) to study drug therapy to disease progression or death due to any cause, whichever occurs first. If the dates of disease progression or death are not available, the DOR will be censored at the date of last valid tumor assessment.	Approximately 2 years
Area under the plasma concentration-time curve within a dosing interval (AUC)	Area under the plasma concentration-time curve within a dosing interval.	Approximately 1 year
QTcF Change from Baseline	QT interval measurement corrected by Fridericia's formula (QTcF).	Up to 9 weeks based on 3 cycles of dosing (21-day cycles)
Duration of Clinical Benefit (DOCB)	DOCB is defined as the time from a subject's objective response (CR or PR) or stable disease (SD) to study drug therapy to disease progression or death due to any cause whichever occurs first.	Approximately 2 years

Collaborators and Investigators

• Sponsor: AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2017
• Primary Completion (Actual): May 2, 2019
• Study Completion (Actual): May 2, 2019

Study Registration Dates

• First Submitted: May 1, 2017
• First Submitted That Met QC Criteria: May 1, 2017
• First Posted (Actual): May 3, 2017

Study Record Updates

• Last Update Posted (Actual): May 14, 2019
• Last Update Submitted That Met QC Criteria: May 10, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Ovarian cancer; Endometrial cancer; SC-004; Maximum tolerated dose (MTD); ABBV-181
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Endometrial Neoplasms
• Other Study ID Numbers: M16-553

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No