Clinical trial · Interventional
A Study of Brontictuzumab With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal Cancer
A Phase 1b Dose Escalation Study of the Safety and Pharmacodynamics of Brontictuzumab in Combination With Chemotherapy for Subjects With Previously Treated Metastatic Colorectal Cancer
NCT03031691CI-TRIAL-00046557completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A Phase 1b Dose Escalation Study of the Safety and Pharmacodynamics of Brontictuzumab in Combination with Chemotherapy for Subjects with Previously Treated Metastatic Colorectal Cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brontictuzumab | Drug | — | UNRESOLVED |
| trifluridine/tipiracil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Brontictuzumab and trifluridine/tipiracil
- description
- Brontictuzumab will be administered per protocol and trifluridine/tipiracil per label.
- interventionNames
- Drug: brontictuzumab
- Drug: trifluridine/tipiracil
Primary outcomes (3)
- measure
- Percentage of patients with adverse events
- timeFrame
- up to approximately 2 years
- measure
- Percentage of patients with dose limiting toxicities
- timeFrame
- 28 days
- measure
- Percentage of patients with anti-brontictuzumab antibodies
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if KRAS wild-type, an anti-EGFR therapy * ECOG performance status 0 or 1 Exclusion Criteria: * Prior treatment with gamma secretase inhibitors or other Notch 1 inhibitors * Subjects with known active HIV infection. Subjects with HIV that are under a stable anti-retroviral regimen and have no evidence of immune deficiency (normal CD4 counts), undetectable viral load, and no HIV-related infections are eligible * Subjects with uncontrolled diarrhea \<30 days prior to first administration of study drug * Subjects with any history of or current clinically significant gastrointestinal disease including, but not limited to: * Inflammatory bowel disease (including ulcerative colitis and Crohn's disease) * Active peptic ulcer disease * Known intraluminal metastatic lesion(s) with risk of bleeding
References
Publications (0)
Data not yet available
No reference posted for this study.