Clinical trial · Interventional
Study of the CD40 Agonistic Monoclonal Antibody APX005M
Phase 1 Study to Evaluate the Safety and Tolerability of the CD40 Agonistic Monoclonal Antibody APX005M in Subjects With Solid Tumors
NCT02482168CI-TRIAL-00072413completedPhase 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)
This study is a phase 1 open-label dose escalation study of the immuno-activating monoclonal antibody APX005M in adults with solid tumors. Study is intended to establish the maximum tolerated dose and the overall safety and tolerability of APX005M in 3 different administration schedules.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
| MSI-H | — | UNRESOLVED | — |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| APX005M | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- APX005M every 3 week
- description
- Subjects receive APX005M intravenously every 3 week until disease progression, unacceptable toxicity or death.
- interventionNames
- Drug: APX005M
- type
- EXPERIMENTAL
- label
- APX005M every 2 week
- description
- Subjects receive APX005M intravenously every 2 week until disease progression, unacceptable toxicity or death.
- interventionNames
- Drug: APX005M
- type
- EXPERIMENTAL
- label
- APX005M every 1 week
- description
- Subjects receive APX005M intravenously every 1 week until disease progression, unacceptable toxicity or death.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Histologically documented diagnosis of solid tumor * For subjects in the every 2 week and every 1 week dosing cohorts histologically or cytologically documented diagnosis of urothelial carcinoma, melanoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, or any solid tumor with high microsatellite instability status (MSI-high) * No known effective therapy options are available * Measurable disease by RECIST 1.1 * ECOG performance status of 0 or 1 * Adequate bone marrow, liver and kidney function * No toxicities related to prior treatment related toxicities with the exception of alopecia and neuropathy * Negative pregnancy test for women of child bearing potential Key Exclusion Criteria: * Any history of or current hematologic malignancy * Major surgery or treatment with any other investigational agent within 4 weeks * Uncontrolled diabetes or hypertension * History of arterial thromboembolic event * History of congestive heart failure, symptomatic ischemia, conduction abnormalities uncontrolled by conventional intervention, or myocardial infarction * Active known clinically serious infections
References
Publications (0)
Data not yet available
No reference posted for this study.