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CancerPhase 1NCT03138408

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

A Phase 1 study testing SC-004 and ABBV-181 in people with Cancer, run by AbbVie at 12 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cancer
What is being tested?
SC-004 and ABBV-181
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
12 sitesUnited States
Study dates
14 Jun 2017to 2 May 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • University of Alabama /ID# 202249

    Birmingham, Alabama, 35294

  • University of Chicago /ID# 200735

    Chicago, Illinois, 60637

  • The Ohio State University - Columbus /ID# 164089

    Columbus, Ohio, 43210

  • Henry Ford Health System /ID# 202480

    Detroit, Michigan, 48202

  • City of Hope /ID# 202493

    Duarte, California, 91010

  • Highlands Oncology Group /ID# 209165

    Fayetteville, Arkansas, 72703-4005

  • MD Anderson Cancer Center /ID# 200048

    Houston, Texas, 77030

  • Tennessee Oncology-Nashville Centennial /ID# 164088

    Nashville, Tennessee, 37203-1632

  • Univ Oklahoma HSC /ID# 164090

    Oklahoma City, Oklahoma, 73104

  • Mayo Clinic - Rochester /ID# 200732

    Rochester, Minnesota, 55905-0001

  • Huntsman Cancer Institute /ID# 209164

    Salt Lake City, Utah, 84112-5500

  • Washington University School /ID# 164091

    St Louis, Missouri, 63108

Other trials in United States

About this study

Official title: 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.

Conditions
Cancer
Being tested
SC-004, ABBV-181
Keywords
Ovarian cancer, Endometrial cancer, SC-004, Maximum tolerated dose (MTD), ABBV-181
Medical subject headings
Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SC-004Drug

    Intravenous

  • ABBV-181Drug

    Intravenous

Study groups in NCT03138408
Study groupRoleWhat they receive
SC-004ExperimentalNot described
Receives: Drug: SC-004
SC-004 and ABBV-181ExperimentalNot described
Receives: Drug: SC-004; Drug: ABBV-181

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Minimum first cycle of dosing (21-day cycles)

Secondary outcomes (12)

  1. Observed plasma concentrations at trough (Ctrough)

    Observed plasma concentrations at trough.

    Measured: Approximately 1 year

  2. Overall Survival (OS)

    OS is defined as the time from the subject's first dose date to death due to any cause.

    Measured: Approximately 2 years

  3. Objective Response Rate (ORR)

    ORR is defined as the proportion of subjects with complete response or partial response (CR+PR).

    Measured: Approximately 2 years

  4. Terminal half life (T1/2)

    Terminal half life (T1/2).

    Measured: Approximately 1 year

  5. Maximum observed serum concentration (Cmax)

    Maximum observed serum concentration.

    Measured: Approximately 1 year

  6. Time to Cmax (Tmax)

    Time to Cmax.

    Measured: Approximately 1 year

  7. Clinical Benefit Rate (CBR)

    CBR is defined as the proportion of subjects with an objective response or stable disease (CR+PR+SD).

    Measured: Approximately 2 years

  8. 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.

    Measured: Approximately 2 years

  9. 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.

    Measured: Approximately 2 years

  10. Area under the plasma concentration-time curve within a dosing interval (AUC)

    Area under the plasma concentration-time curve within a dosing interval.

    Measured: Approximately 1 year

  11. QTcF Change from Baseline

    QT interval measurement corrected by Fridericia's formula (QTcF).

    Measured: Up to 9 weeks based on 3 cycles of dosing (21-day cycles)

  12. 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.

    Measured: Approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2017
  2. Study start14 Jun 2017
  3. Primary completion2 May 2019
  4. Study completion2 May 2019

Why it stopped: Strategic considerations

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03138408
Sponsor's protocol ID
M16-553
Status last verified
May 2019
First submitted
1 May 2017
Last updated
14 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SC-004 and ABBV-181 in people with Cancer, run by AbbVie at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Strategic considerations). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with dose-limiting toxicities (DLT) (time frame: Minimum first cycle of dosing (21-day cycles)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03138408.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2019.

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