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Colorectal CancerPhase 1NCT03035279

A Study of SC-006 and in Combination With ABBV-181 in Subjects With Advanced Colorectal Cancer

A Phase 1 study testing SC-006 and ABBV-181 in people with Colorectal Cancer, run by AbbVie at 9 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 multicenter, open-label, Phase 1 study of SC-006 given as a single agent and in combination with ABBV-181 in participants with advanced colorectal cancer (CRC), and consists of Part A (single agent SC-006 dose regimen finding), followed by Part B (single agent SC-006 dose expansion), and Part C (SC-006 and… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
SC-006 and ABBV-181
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
9 sitesUnited States
Study dates
8 Mar 2017to 28 Mar 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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants with histologically or cytologically confirmed advanced metastatic or unresectable colorectal cancer (CRC) that is relapsed, refractory, or progressive following at least 2 prior systemic regimens in the metastatic setting.
  • Participants with an Eastern Cooperative Oncology Group (ECOG) of 0 - 1.
  • Participants with adequate hematologic, hepatic, and renal function.

Who cannot join

  • Participants with prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug.
  • Additional Exclusion Criteria for the SC-006 and ABBV-181 Combination Treatment Regimen:
  • History of inflammatory bowel disease
  • Active autoimmune disease, with exception of psoriasis not requiring systemic treatment, vitiligo, type 1 diabetes mellitus and hypothyroidism
  • History of primary immunodeficiency, allogenic bone marrow transplantation, solid organ transplantation, or previous clinical diagnosis of tuberculosis
  • History of immune-mediated pneumonitis
  • Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • University of Michigan Hospitals /ID# 167101

    Ann Arbor, Michigan, 48109-5008

  • Highlands Oncology Group /ID# 201182

    Fayetteville, Arkansas, 72703-4005

  • Carolina BioOncology Institute /ID# 202712

    Huntersville, North Carolina, 28078

  • University of California, Los Angeles /ID# 160882

    Los Angeles, California, 90095

  • Tennessee Oncology-Nashville Centennial /ID# 160880

    Nashville, Tennessee, 37203-1632

  • Memorial Sloan Kettering Cancer Center /ID# 160881

    New York, New York, 10065-6007

  • Oklahoma University /ID# 202713

    Oklahoma City, Oklahoma, 73104

  • Mayo Clinic - Rochester /ID# 160884

    Rochester, Minnesota, 55905-0001

  • Washington University-School of Medicine /ID# 160883

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: An Open Label Phase 1 Study of SC-006 as a Single Agent and in Combination With ABBV-181 in Subjects With Advanced Colorectal Cancer

This is a multicenter, open-label, Phase 1 study of SC-006 given as a single agent and in combination with ABBV-181 in participants with advanced colorectal cancer (CRC), and consists of Part A (single agent SC-006 dose regimen finding), followed by Part B (single agent SC-006 dose expansion), and Part C (SC-006 and ABBV-181 combination escalation and expansion). Part A (dose regimen finding) will involve dose escalation and possible dose interval modification to define the maximum tolerated dose (MTD) and/or recommended Part B dose and schedule. Part B (dose expansion) will enroll additional participants who will be treated with a study drug dose at or below the MTD determined in Part A. Part C is dose escalation of SC-006 and fixed dose of ABBV-181 in combination. Recommended dose cohort of SC-006 with ABBV-181 will be expanded.

Being tested
SC-006, ABBV-181
Keywords
Advanced colorectal cancer, Cancer, Metastatic colorectal cancer, Unresectable colorectal cancer, Maximum tolerated dose, Pharmacokinetics
Medical subject headings
Colorectal Neoplasms, Neoplasms

What participants receive

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

  • SC-006Drug

    Intravenous

  • ABBV-181Drug

    Intravenous

Study groups in NCT03035279
Study groupRoleWhat they receive
Arm AExperimentalSC-006 Dose regimen finding
Receives: Drug: SC-006
Arm BExperimentalSC-006 Dose expansion
Receives: Drug: SC-006
Arm CExperimentalSC-006 and ABBV-181 Combination escalation and expansion
Receives: Drug: SC-006; 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 (11)

  1. Overall Survival (OS)

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

    Measured: Approximately 2 years

  2. Progression Free Survival (PFS)

    PFS time is defined as the time from the participant's first dose of study drug (Day 1) to either the participant's disease progression or death due to any cause.

    Measured: Approximately 2 years

  3. Time to Cmax (Tmax) of SC-006

    Time to Cmax of SC-006

    Measured: Approximately 1 year

  4. Area under the plasma concentration-time curve within a dosing interval (AUC) of SC-006

    Area under the plasma concentration-time curve within a dosing interval of SC-006

    Measured: Approximately 1 year

  5. Duration of Clinical Benefit (DOCB)

    DOCB is defined as the time from the initial partial response (PR), complete response (CR), or stable disease to disease progression.

    Measured: Approximately 2 years

  6. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants whose best overall response is either complete response (CR) or partial response (PR), as determined by Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: Approximately 2 years

  7. Terminal half life (T1/2) of SC-006

    Terminal half life (T1/2) of SC-006

    Measured: Approximately 1 year

  8. Duration of response (DOR)

    DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression or death, whichever occurs first.

    Measured: Approximately 2 years

  9. Observed plasma concentrations at trough (Ctrough) of SC-006

    Observed plasma concentrations at trough of SC-006

    Measured: Approximately 1 year

  10. Clinical Benefit Rate (CBR) defined as CR, PR, or stable disease (SD)

    CBR is defined as the percentage of participants who achieve a best response of CR, PR, or stable disease (SD).

    Measured: Approximately 2 years

  11. Maximum observed serum concentration (Cmax) of SC-006

    Maximum observed serum concentration of SC-006

    Measured: Approximately 1 year

Timeline

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

  1. First posted30 Jan 2017 (estimated)
  2. Study start8 Mar 2017
  3. Primary completion28 Mar 2019
  4. Study completion28 Mar 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
Sequential
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03035279
Sponsor's protocol ID
M16-312
Status last verified
Feb 2020
First submitted
23 Jan 2017
Last updated
20 Feb 2020
Results posted
No
Data monitoring committee
Yes
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-006 and ABBV-181 in people with Colorectal Cancer, run by AbbVie at 9 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 3 inclusion and 7 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 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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 NCT03035279.

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 20 Feb 2020.

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