Status:
TERMINATED
A Study of SC-007 in Subjects With Advanced Cancer
Lead Sponsor:
AbbVie
Conditions:
Colorectal Cancer (CRC)
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 find...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 13 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2018
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03253185
Start Date
September 13 2017
End Date
April 2 2018
Last Update
April 27 2018
Active Locations (7)
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1
University of California, Los Angeles
Los Angeles, California, United States, 90095
2
Mayo Clinic
Rochester, Minnesota, United States, 55905-0001
3
Washington University-School of Medicine
St Louis, Missouri, United States, 63110
4
Gabrail Cancer Center Research
Canton, Ohio, United States, 44718