A Study of SC-007 in Subjects With Advanced Cancer



Status:Terminated
Conditions:Colorectal Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/29/2018
Start Date:September 13, 2017
End Date:April 2, 2018

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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.


Inclusion Criteria:

- 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 Criteria:

- 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.
We found this trial at
7
sites
Houston, Texas 77030
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Houston, TX
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Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Los Angeles, CA
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Canton, OH
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Nashville, TN
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Rochester, Minnesota 55905
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Rochester, MN
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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San Antonio, TX
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