NCT03138408

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 cancer

Timeline
Completed

Started Jun 2017

Shorter than P25 for phase_1 cancer

Geographic Reach
1 country

12 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

June 14, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2019

Completed
Last Updated

May 14, 2019

Status Verified

May 1, 2019

Enrollment Period

1.9 years

First QC Date

May 1, 2017

Last Update Submit

May 10, 2019

Conditions

Cancer

Keywords

Ovarian cancerEndometrial cancerSC-004Maximum tolerated dose (MTD)ABBV-181

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Observed plasma concentrations at trough (Ctrough)

    Approximately 1 year

  • Overall Survival (OS)

    Approximately 2 years

  • Objective Response Rate (ORR)

    Approximately 2 years

  • Terminal half life (T1/2)

    Approximately 1 year

  • Maximum observed serum concentration (Cmax)

    Approximately 1 year

  • +7 more secondary outcomes

Study Arms (2)

SC-004

EXPERIMENTAL
Drug: SC-004

SC-004 and ABBV-181

EXPERIMENTAL
Drug: SC-004Drug: ABBV-181

Interventions

SC-004DRUG

Intravenous

SC-004SC-004 and ABBV-181
ABBV-181DRUG

Intravenous

SC-004 and ABBV-181

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

University of Alabama /ID# 202249

Birmingham, Alabama, 35294, United States

Location

Highlands Oncology Group /ID# 209165

Fayetteville, Arkansas, 72703-4005, United States

Location

City of Hope /ID# 202493

Duarte, California, 91010, United States

Location

University of Chicago /ID# 200735

Chicago, Illinois, 60637, United States

Location

Henry Ford Health System /ID# 202480

Detroit, Michigan, 48202, United States

Location

Mayo Clinic - Rochester /ID# 200732

Rochester, Minnesota, 55905-0001, United States

Location

Washington University School /ID# 164091

St Louis, Missouri, 63108, United States

Location

The Ohio State University - Columbus /ID# 164089

Columbus, Ohio, 43210, United States

Location

Univ Oklahoma HSC /ID# 164090

Oklahoma City, Oklahoma, 73104, United States

Location

Tennessee Oncology-Nashville Centennial /ID# 164088

Nashville, Tennessee, 37203-1632, United States

Location

MD Anderson Cancer Center /ID# 200048

Houston, Texas, 77030, United States

Location

Huntsman Cancer Institute /ID# 209164

Salt Lake City, Utah, 84112-5500, United States

Location

MeSH Terms

Conditions

NeoplasmsOvarian NeoplasmsEndometrial Neoplasms

Interventions

SC004budigalimab

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersUterine NeoplasmsUterine Diseases

Study Officials

  • AbbVie Inc.

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2017

First Posted

May 3, 2017

Study Start

June 14, 2017

Primary Completion

May 2, 2019

Study Completion

May 2, 2019

Last Updated

May 14, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations

US(12)