Clinical trial NCT03253185: A Study of SC-007 in Subjects With Advanced Cancer
Official title: An Open Label Study of SC-007 in Subjects With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Colorectal Cancer (CRC)
Gastric Cancer
Keywords: Cancer
Advanced cancer
Esophagogastric junction (EGJ) cancers
Maximum tolerated dose (MTD)
Maximum Tolerated Dose
Pharmacokinetics
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-08-17
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with dose-limiting toxicities (DLTs)
timeFrame: Minimum first cycle of dosing (Up to 21 days)
Secondary outcomes:
measure: Clinical Benefit Rate (CBR)
timeFrame: Approximately 4 years
measure: Progression Free Survival (PFS)
timeFrame: Approximately 4 years
measure: Observed plasma concentrations at trough (Ctrough) of SC-007
timeFrame: Approximately 1 year
measure: Incidence of Anti-therapeutic Antibodies (ATAs) against SC-007
timeFrame: Approximately 4 years
measure: Overall Survival (OS)
timeFrame: Approximately 4 years
measure: Terminal half life (T1/2) of SC-007
timeFrame: Approximately 1 year
measure: Objective Response Rate (ORR)
timeFrame: Approximately 4 years
measure: Duration of Response (DOR)
timeFrame: Approximately 4 years
measure: Time to Cmax (Tmax) of SC-007
timeFrame: Approximately 1 year
measure: Area under the plasma concentration-time curve within a dosing interval (AUC) of SC-007
timeFrame: Approximately 1 year
measure: QTcF Change from Baseline
timeFrame: Up to 9 weeks based on 3 cycles of dosing (21-day cycles)
measure: Maximum observed serum concentration (Cmax) of SC-007
timeFrame: Approximately 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University-School of Medicine
state: Missouri
city: Canton
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Nashville
country: United States
facility: Tennessee Oncology-Sarah Cannon Research Institute
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics
state: Texas
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: