A Study of SC-007 in Subjects With Advanced Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-13

Study Completion Date

2018-04-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of SC-006 and in Combination With ABBV-181 in Subjects With Advanced Colorectal Cancer

NCT03035279

Colorectal Cancer

TERMINATED PHASE1

S9923 R115777 in Treating Patients With Advanced Colorectal Cancer

NCT00005833

Colorectal Cancer

COMPLETED PHASE2

S0030: Capecitabine in Treating Older Patients W/Metastatic or Recurrent Colorectal Cancer That Cannot Be Surgically Removed

NCT00049335

Colorectal Cancer

COMPLETED PHASE2

Study SBX-01-101: A Stool Collection Study in Colorectal Cancer (CRC) Patients Treated With Irinotecan-Based Regimens

NCT05821582

Colorectal Cancer

WITHDRAWN

SB-715992 in Treating Patients With Advanced or Metastatic Colorectal Cancer

NCT00103311

Recurrent Colon Cancer Recurrent Rectal Cancer Stage IIIA Colon Cancer +9 more

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer (CRC) Gastric Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SC-007

SC-007 intravenous (IV) (various doses and dose regimens)

Group Type EXPERIMENTAL

SC-007

Intervention Type DRUG

intravenous

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SC-007

intravenous

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes