Breast CancerPhase 1NCT03316794
A Study of SC-005 in Subjects With Triple Negative Breast Cancer (TNBC)
A Phase 1 study testing SC-005 in people with Breast Cancer, run by AbbVie at 8 sites in United States.
Trial summary
This is a multicenter, open-label study in participants with triple negative breast cancer (TNBC) to study the safety, tolerability, pharmacokinetics and preliminary efficacy of SC-005. This study consists of 2 parts: Part A (dose regimen finding) followed by Part B (dose expansion). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SC-005
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 8 sitesUnited States
- Study dates
- 4 Jan 2018to 5 Oct 2018
- 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
- Histologically or cytologically confirmed advanced TNBC that is relapsed, refractory, or progressive and not eligible for another standard therapy that would confer clinical benefit to the subject.
- Advanced disease is defined as metastatic disease or locally advanced disease that is not amenable to surgery or radiotherapy with curative intent
- TNBC is defined as:
- <1% staining by immunohistochemistry (IHC) for estrogen (ER) and progesterone (PR) receptors, 0 or 1+ IHC for human epidermal growth factor receptor 2 (HER2), OR
- Negative for HER2 amplification by in situ hybridization (ISH) for 2+ IHC disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate hematologic, hepatic, and renal function.
Who cannot join
- Any significant medical condition including any suggested by Screening laboratory findings that, in the opinion of the Investigator or Sponsor, may place the subject at undue risk from the study.
- Has ECG abnormalities that make QT interval corrected (QTc) evaluation difficult (e.g., severe morphologic abnormalities).
- Prior exposure to a pyrrolobenzodiazepine or indolino-benzodiazepine based drug, or known hypersensitivity or contraindication to SC-005 or excipient contained in the drug formulation.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Gabrail Cancer Center Research /ID# 168756
Canton, Ohio, 44718
University of Chicago /ID# 169231
Chicago, Illinois, 60637-1443
Baylor University /ID# 169860
Houston, Texas, 77030
MD Anderson Cancer Center /ID# 169232
Houston, Texas, 77030
Tennessee Oncology-Sarah Cannon Research Institute /ID# 169233
Nashville, Tennessee, 37203
Memorial Sloan Kettering /ID# 201016
New York, New York, 10065
Oklahoma University /ID# 200937
Oklahoma City, Oklahoma, 73104
Washington University School /ID# 169177
St Louis, Missouri, 63108
About this study
Official title: An Open-Label Study of SC-005 in Subjects With Triple Negative Breast Cancer (TNBC)
This is a multicenter, open-label study in participants with triple negative breast cancer (TNBC) to study the safety, tolerability, pharmacokinetics and preliminary efficacy of SC-005. This study consists of 2 parts: Part A (dose regimen finding) followed by Part B (dose expansion).
- Conditions
- Breast Cancer
- Being tested
- SC-005
- Keywords
- Triple Negative Breast Cancer, Cancer, Breast Cancer, Maximum tolerated dose (MTD), Pharmacokinetics
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SC-005Drug
intravenous
| Study group | Role | What they receive |
|---|---|---|
| SC-005 | Experimental | SC-005 intravenous (IV) (various doses and dose regimens) Receives: Drug: SC-005 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Dose-limiting Toxicities (DLTs)
DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Measured: Minimum 21 days
Secondary outcomes (11)
QTcF Change from Baseline
QT interval measurement corrected by Fridericia's formula (QTcF)
Measured: Up to approximately 9 weeks
Area Under the Plasma Concentration-time Curve (AUC)
Area under the plasma concentration-time curve (AUC) of SC-005.
Measured: Up to approximately 9 weeks
Clinical benefit rate (CBR)
CBR is defined as the proportion of participants with an objective response or stable disease (CR+PR +SD).
Measured: Up to approximately 4 years
Maximum plasma concentration observed (Cmax)
Maximum plasma concentration observed (Cmax) of SC-005
Measured: Up to approximately 9 weeks
Overall Survival (OS)
OS is defined as the time from the participant's first dose date to death due to any cause.
Measured: Up to approximately 4 years
Observed Plasma Concentrations at Trough
Observed plasma concentrations at trough of SC-005.
Measured: Up to approximately 9 weeks
Duration of Clinical Benefit (DOCB)
DOCB is defined as the time from the participant's initial observation of clinical benefit (CR or PR or stable disease [SD]) to PD or death due to any cause, whichever occurs first.
Measured: Up to approximately 4 years
Objective Response Rate (ORR)Up to approximately 4 years
Objective response rate is defined as the proportion of participants with complete response (CR) or partial response (PR) based on RECIST version 1.1.
Measured: Up to approximately 4 years
Time of Cmax (Tmax)
Time of Cmax (Tmax) of SC-005.
Measured: Up to approximately 9 weeks
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: Up to approximately 4 years
Duration of Response (DOR)
DOR is defined as the time from the participants initial objective response (CR or PR) to disease progression (PD) or death due to any cause, whichever occurs first.
Measured: Up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start4 Jan 2018
- Primary completion5 Oct 2018
- Study completion5 Oct 2018
Why it stopped: Strategic considerations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316794
- Sponsor's protocol ID
- M16-735
- Status last verified
- Dec 2018
- First submitted
- 18 Oct 2017
- Last updated
- 17 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study of SC-005 in Subjects With Triple Negative Breast Cancer (TNBC)
- ClinicalTrials.gov ID
- NCT03316794
- Acronym / sponsor ID
- M16-735
- Conditions
- Breast Cancer
- Keywords
- Triple Negative Breast Cancer, Cancer, Breast Cancer, Maximum tolerated dose (MTD), Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic considerations
- Enrolment
- 2 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 5 Oct 2018 (actual)
- Study completion
- 5 Oct 2018 (actual)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, open-label study in participants with triple negative breast cancer (TNBC) to study the safety, tolerability, pharmacokinetics and preliminary efficacy of SC-005. This study consists of 2 parts: Part A (dose regimen finding) followed by Part B (dose expansion).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SC-005 | Experimental | Drug: SC-005SC-005 intravenous (IV) (various doses and dose regimens) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed advanced TNBC that is relapsed, refractory, or progressive and not eligible for another standard therapy that would confer clinical benefit to the subject.
- <1% staining by immunohistochemistry (IHC) for estrogen (ER) and progesterone (PR) receptors, 0 or 1+ IHC for human epidermal growth factor receptor 2 (HER2), OR
- Negative for HER2 amplification by in situ hybridization (ISH) for 2+ IHC disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate hematologic, hepatic, and renal function.
Key exclusion criteria (3 listed)
- Any significant medical condition including any suggested by Screening laboratory findings that, in the opinion of the Investigator or Sponsor, may place the subject at undue risk from the study.
- Has ECG abnormalities that make QT interval corrected (QTc) evaluation difficult (e.g., severe morphologic abnormalities).
- Prior exposure to a pyrrolobenzodiazepine or indolino-benzodiazepine based drug, or known hypersensitivity or contraindication to SC-005 or excipient contained in the drug formulation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SC-005intravenous | Drug | SC-005 |
Primary outcome
Number of Participants with Dose-limiting Toxicities (DLTs)
Time frame: Minimum 21 days
DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
11 secondary outcomes
QTcF Change from Baseline
Time frame: Up to approximately 9 weeks
Area Under the Plasma Concentration-time Curve (AUC)
Time frame: Up to approximately 9 weeks
Clinical benefit rate (CBR)
Time frame: Up to approximately 4 years
Maximum plasma concentration observed (Cmax)
Time frame: Up to approximately 9 weeks
Overall Survival (OS)
Time frame: Up to approximately 4 years
Observed Plasma Concentrations at Trough
Time frame: Up to approximately 9 weeks
Duration of Clinical Benefit (DOCB)
Time frame: Up to approximately 4 years
Objective Response Rate (ORR)Up to approximately 4 years
Time frame: Up to approximately 4 years
Time of Cmax (Tmax)
Time frame: Up to approximately 9 weeks
Progression Free Survival (PFS)
Time frame: Up to approximately 4 years
Duration of Response (DOR)
Time frame: Up to approximately 4 years
Results and safety
The study was stopped early (reason given: Strategic considerations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AbbVie Inc. study director
AbbVie
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SC-005 in people with Breast Cancer, run by AbbVie at 8 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 7 inclusion and 3 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 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 (DLTs) (time frame: Minimum 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2018.