Colorectal Cancer (CRC)Phase 1NCT03253185
A Study of SC-007 in Subjects With Advanced Cancer
A Phase 1 study testing SC-007 in people with Colorectal Cancer (CRC) and Gastric Cancer, run by AbbVie at 7 sites in United States.
Trial summary
This is a multicenter, open-label, Phase 1 study in participants with colorectal cancer (CRC) or gastric cancer to study the safety and tolerability of SC-007 and consists of Part A (dose regimen finding) in participants with CRC followed by Part A in participants with gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer (CRC), Gastric Cancer
- What is being tested?
- SC-007
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 7 sitesUnited States
- Study dates
- 13 Sep 2017to 2 Apr 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed advanced metastatic or unresectable advanced colorectal cancer (CRC) or gastric cancer that is relapsed, refractory, or progressive after:
- CRC: at least 2 prior systemic regimens in the metastatic setting, and as appropriate in patients whose tumors are microsatellite instability-high (MSI-H), pembrolizumab as well.
- Gastric cancer (including gastric and EGJ cancers): at least 2 prior systemic regimens in adjuvant, advanced, or metastatic setting and, as appropriate, a human epidermal growth factor receptor 2 (HER2) targeted agent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate hematologic, hepatic, and renal function.
Who cannot join
- Any significant medical condition that, in the opinion of the investigator or sponsor, may place the participant at undue risk from the study.
- Has electrocardiogram (ECG) abnormalities that make QT interval corrected (QTc) evaluation difficult.
- Prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Gabrail Cancer Center Research
Canton, Ohio, 44718
MD Anderson Cancer Center
Houston, Texas, 77030
University of California, Los Angeles
Los Angeles, California, 90095
Tennessee Oncology-Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Mayo Clinic
Rochester, Minnesota, 55905-0001
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
Washington University-School of Medicine
St Louis, Missouri, 63110
About this study
Official title: An Open Label Study of SC-007 in Subjects With Advanced Cancer
This is a multicenter, open-label, Phase 1 study in participants with colorectal cancer (CRC) or gastric cancer to study the safety and tolerability of SC-007 and consists of Part A (dose regimen finding) in participants with CRC followed by Part A in participants with gastric cancer. Part B (dose expansion) will enroll participants into separate disease specific cohorts of CRC or gastric cancer.
- Conditions
- Colorectal Cancer (CRC), Gastric Cancer
- Being tested
- SC-007
- Keywords
- Cancer, Advanced cancer, Esophagogastric junction (EGJ) cancers, Maximum tolerated dose (MTD), Maximum Tolerated Dose, Pharmacokinetics
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SC-007Drug
intravenous
| Study group | Role | What they receive |
|---|---|---|
| SC-007 | Experimental | SC-007 intravenous (IV) (various doses and dose regimens) Receives: Drug: SC-007 |
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 first cycle of dosing (Up to 21 days)
Secondary outcomes (12)
Clinical Benefit Rate (CBR)
CBR is defined as the proportion of participants with an objective response or stable disease (CR+PR+SD).
Measured: Approximately 4 years
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 4 years
Observed plasma concentrations at trough (Ctrough) of SC-007
Observed plasma concentrations at trough of SC-007
Measured: Approximately 1 year
Incidence of Anti-therapeutic Antibodies (ATAs) against SC-007
Incidence of ATAs against SC-007
Measured: Approximately 4 years
Overall Survival (OS)
OS is defined as the time from the participant's first dose date to death due to any cause.
Measured: Approximately 4 years
Terminal half life (T1/2) of SC-007
Terminal half life of SC-007
Measured: Approximately 1 year
Objective Response Rate (ORR)
ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
Measured: Approximately 4 years
Duration of Response (DOR)
DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first.
Measured: Approximately 4 years
Time to Cmax (Tmax) of SC-007
Time to Cmax of SC-007
Measured: Approximately 1 year
Area under the plasma concentration-time curve within a dosing interval (AUC) of SC-007
Area under the plasma concentration-time curve within a dosing interval of SC-007
Measured: Approximately 1 year
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)
Maximum observed serum concentration (Cmax) of SC-007
Maximum observed serum concentration of SC-007
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.
- First posted17 Aug 2017
- Study start13 Sep 2017
- Primary completion20 Mar 2018
- Study completion2 Apr 2018
Why it stopped: Benefit/Risk Imbalance
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC)Studies 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
- 7 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
- NCT03253185
- Sponsor's protocol ID
- M16-310
- Status last verified
- Apr 2018
- First submitted
- 14 Aug 2017
- Last updated
- 27 Apr 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 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Study of SC-007 in Subjects With Advanced Cancer
- ClinicalTrials.gov ID
- NCT03253185
- Acronym / sponsor ID
- M16-310
- Conditions
- Colorectal Cancer (CRC), Gastric Cancer
- Keywords
- Cancer, Advanced cancer, Esophagogastric junction (EGJ) cancers, Maximum tolerated dose (MTD), Maximum Tolerated Dose, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Benefit/Risk Imbalance
- Enrolment
- 7 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2017 (actual)
- Primary completion
- 20 Mar 2018 (actual)
- Study completion
- 2 Apr 2018 (actual)
- First posted
- 17 Aug 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, Phase 1 study in participants with colorectal cancer (CRC) or gastric cancer to study the safety and tolerability of SC-007 and consists of Part A (dose regimen finding) in participants with CRC followed by Part A in participants with gastric cancer. Part B (dose expansion) will enroll participants into separate disease specific cohorts of CRC or gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SC-007 | Experimental | Drug: SC-007SC-007 intravenous (IV) (various doses and dose regimens) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed advanced metastatic or unresectable advanced colorectal cancer (CRC) or gastric cancer that is relapsed, refractory, or progressive after:
- CRC: at least 2 prior systemic regimens in the metastatic setting, and as appropriate in patients whose tumors are microsatellite instability-high (MSI-H), pembrolizumab as well.
- Gastric cancer (including gastric and EGJ cancers): at least 2 prior systemic regimens in adjuvant, advanced, or metastatic setting and, as appropriate, a human epidermal growth factor receptor 2 (HER2) targeted agent.
- 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 that, in the opinion of the investigator or sponsor, may place the participant at undue risk from the study.
- Has electrocardiogram (ECG) abnormalities that make QT interval corrected (QTc) evaluation difficult.
- Prior exposure to a pyrrolobenzodiazepine or indolinobenzodiazepine based drug.
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-007intravenous | Drug | SC-007 |
Primary outcome
Number of participants with dose-limiting toxicities (DLTs)
Time frame: Minimum first cycle of dosing (Up to 21 days)
DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
12 secondary outcomes
Clinical Benefit Rate (CBR)
Time frame: Approximately 4 years
Progression Free Survival (PFS)
Time frame: Approximately 4 years
Observed plasma concentrations at trough (Ctrough) of SC-007
Time frame: Approximately 1 year
Incidence of Anti-therapeutic Antibodies (ATAs) against SC-007
Time frame: Approximately 4 years
Overall Survival (OS)
Time frame: Approximately 4 years
Terminal half life (T1/2) of SC-007
Time frame: Approximately 1 year
Objective Response Rate (ORR)
Time frame: Approximately 4 years
Duration of Response (DOR)
Time frame: Approximately 4 years
Time to Cmax (Tmax) of SC-007
Time frame: Approximately 1 year
Area under the plasma concentration-time curve within a dosing interval (AUC) of SC-007
Time frame: Approximately 1 year
QTcF Change from Baseline
Time frame: Up to 9 weeks based on 3 cycles of dosing (21-day cycles)
Maximum observed serum concentration (Cmax) of SC-007
Time frame: Approximately 1 year
Results and safety
The study was stopped early (reason given: Benefit/Risk Imbalance). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 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
7 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-007 in people with Colorectal Cancer (CRC) and Gastric Cancer, run by AbbVie at 7 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 5 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 27 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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: Benefit/Risk Imbalance). 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 first cycle of dosing (Up to 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 27 Apr 2018.