Clinical trial · Interventional
A Study of SC-007 in Subjects With Advanced Cancer
An Open Label Study of SC-007 in Subjects With Advanced Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Benefit/Risk Imbalance
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer (CRC) | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SC-007 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SC-007
- description
- SC-007 intravenous (IV) (various doses and dose regimens)
- interventionNames
- Drug: SC-007
Primary outcomes (1)
- measure
- Number of participants with dose-limiting toxicities (DLTs)
- timeFrame
- Minimum first cycle of dosing (Up to 21 days)
- description
- DLTs graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Secondary outcomes (12)
- measure
- Clinical Benefit Rate (CBR)
- timeFrame
- Approximately 4 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available