A Phase 1 Dose Escalation Study of AV-203, an ERBB3 Inhibitory Antibody, in Subjects With Advanced Solid Tumors
| Status: | Completed |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/3/2014 |
| Start Date: | May 2012 |
| End Date: | October 2014 |
| Contact: | Philip Komarnitsky, MD |
| Email: | pkomarnitsky@aveooncology.com |
| Phone: | 617-299-5654 |
A Phase 1 Open-label, Multiple Dose, Dose Escalation Study of Monoclonal Antibody AV-203 Administered in Subjects With Metastatic or Advanced Solid Tumors
This is a Phase 1, multi-center, open-label, multiple dose, dose escalation study to
evaluate the safety, tolerability, dose limiting toxicities (DLTs), maximum tolerated dose
(MTD) and/or Recommended Phase 2 Dose (RP2D), pharmacokinetic (PK), pharmacodynamics, and
preliminary anti-tumor activity of AV-203, an ERBB3 inhibitory antibody, administered once
every 2 weeks via intravenous (IV) infusion in subjects with metastatic or advanced solid
tumors. Once the RP2D is determined, patients with tumor types of interest will be
evaluated in an expansion cohort at the RP2D for safety and anti-tumor activity.
evaluate the safety, tolerability, dose limiting toxicities (DLTs), maximum tolerated dose
(MTD) and/or Recommended Phase 2 Dose (RP2D), pharmacokinetic (PK), pharmacodynamics, and
preliminary anti-tumor activity of AV-203, an ERBB3 inhibitory antibody, administered once
every 2 weeks via intravenous (IV) infusion in subjects with metastatic or advanced solid
tumors. Once the RP2D is determined, patients with tumor types of interest will be
evaluated in an expansion cohort at the RP2D for safety and anti-tumor activity.
Inclusion Criteria:
- ≥ 18 years of age
- Histologically and/or cytologically confirmed primary diagnosis
- Metastatic or advanced solid tumor, that has recurred or progressed following
standard therapies, or for which no standard therapy exists
- Must have available tumor tissue or be willing to undergo biopsy prior to enrollment
- Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1
- Blood Chemistry and Hematology results within defined limits
Exclusion Criteria:
- History of severe allergic or anaphylactic reactions or hypersensitivity to
recombinant proteins or excipients in the investigational agent
- Current central nervous system (CNS) or leptomeningeal metastases, or history of CNS
or leptomeningeal metastases.
- Significant conduction disturbance, history of a severe arrhythmia, or history of a
familial arrhythmia
- Significant cardiovascular disease
- Significant thromboembolic or vascular disorders within prior 3 months
- Any other medical condition or psychiatric condition that, in the opinion of the
Investigator, might interfere with the subject's participation in the trial or
interfere with the interpretation of trial results
- Known history of positive results for hepatitis C, hepatitis B, or human
immunodeficiency virus.
- For female subjects, pregnancy or lactation.
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