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

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

sites

University of California at Los Angeles

Los Angeles, California 90095

310-825-4321