A Study of SC-007 in Subjects With Advanced Cancer

AbbVie

Status and phase

Terminated

Phase 1

Conditions

Colorectal Cancer (CRC)

Gastric Cancer

Treatments

Drug: SC-007

Study type

Interventional

Funder types

Industry

Identifiers

NCT03253185

M16-310

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.