Clinical trial · Interventional
Safety and Tolerability of hCBE-11 in Subjects With Advanced Solid Tumors
A Phase I, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of hCBE-11, a Humanized Monoclonal Antibody, in Subjects With Advanced Solid Tumors
- 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)
This is a Phase I, open-label, dose-escalation study on subjects with advanced solid tumors. This is the first study of hCBE-11 in humans and is designed to determine the safety and how well patients tolerate this investigational drug. The study duration is two years with treatment visits occurring weekly for either 4 or 8 weeks, follow-up for 8 weeks and long-term follow-up contact every 3 months thereafter.
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 |
|---|---|---|---|
| Tumors | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hCBE-11 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To evaluate the safety and tolerability of hCBE-11 in advanced solid tumors
- timeFrame
- up to 2 years
Secondary outcomes (1)
- measure
- To define the recommended Phase II dose of hCBE-11
- timeFrame
- up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Relapsed or refractory solid tumors not curable with standard therapy. * At least one measurable lesion * ECOG Performance Status less than or equal to 2 * Acceptable hematologic status * Albumin greater than or equal to 2.5 g/dL * Normal calculated glomerular filtration rate (GFR) * Acceptable liver function Exclusion Criteria: * Uncontrolled cardiac disease, angina, congestive heart failure, or myocardial infarction within 6 months prior to Study Day * Known history of hepatitis B or C, or HIV infection * Clinically significant effusions, including pericardial, pleural, and ascites * Serious non-malignant disease * Central nervous system (CNS) metastatic involvement except where the disease has been successfully treated * Investigational therapies within 4 weeks of Study Day 1 * Radiation therapy of tumors to be followed for this study * Chemotherapy, biologic therapy, or major surgery other than diagnostic within 4 weeks prior to Study Day 1 * Current Grade 3 or 4 neurological toxicity * Concurrent anti-neoplastic therapy and/or steroids
References
Publications (0)
Data not yet available