Clinical trial · Interventional
A Study of OMP-305B83 in Subjects With Metastatic Colorectal Cancer
A Phase 1b Study of OMP-305B83 Plus FOLFIRI or FOLFOX as Second Line Therapy in Subjects With Metastatic Colorectal Cancer
- 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)
The purpose of this study is to test the safety and efficacy of an experimental drug, OMP-305B83, when given in combination with FOLFIRI or FOLFOX. OMP-305B83 is a humanized bispecific monoclonal antibody and was developed to target cancer stem cells. Based on preclinical studies, it is believed that OMP-305B83 may block the growth of cancer stem cells and may also impair the productive growth of new blood vessels, which tumors need to grow and spread. The study is sponsored by OncoMed Pharmaceuticals, which is referred to as OncoMed or the Sponsor.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FOLFIRI | Drug | FOLFIRI Regimen | ALIAS |
| FOLFOX | Drug | FOLFOX Regimen | ALIAS |
| OMP-305B83 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OMP-305B83 combined with FOLFIRI or FOLFOX
- interventionNames
- Drug: OMP-305B83
- Drug: FOLFIRI
- Drug: FOLFOX
Primary outcomes (1)
- measure
- Incidence of dose limiting toxicities
- timeFrame
- Subjects will be treated and observed for DLT through the end of the first cycle (Days 0-28).
- description
- The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with OMP-305B83 in combination with FOLFIRI or FOLFOX
Secondary outcomes (5)
- measure
- Safety of OMP-305B83 in combination with FOLFIRI or FOLFOX will be assessed by adverse event monitoring, physical exams, vital signs, clinical laboratory testing, ECGs, echocardiograms, anti-OMP-305B83 testing, and subject interview on an ongoing basis.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * Measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1 * Age \>21 years * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate organ and marrow function * For women of childbearing potential and men with partners of childbearing potential, agreement (by patient and/or partner) to use two effective forms of contraception from study entry through at least 6 months after the termination visit. * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Receiving any other investigational agents or any other anti-cancer therapy * Receiving prior hepatic intra-arterial chemotherapy * Known significant clinically significant gastrointestinal disease * Patients with brain metastases (treated or untreated) leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease * Significant intercurrent illness that will limit the patient's ability to participate in the study or may result in their death over the next 18 months * Pregnant or nursing women * Inability to comply with study and follow up procedure
References
Publications (0)
Data not yet available