A Phase 1, Open-Label, Multi-center, Dose Escalation Study of the Safety and Pharmacokinetics of AGS-16M18 Given as Monotherapy in Subjects With Advanced Renal Cell Carcinoma
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Astellas Pharma Inc
- Enrollment
- 7
- Locations
- 2
- Primary Endpoint
- Incidence of adverse events
Study Overview
Brief Summary
This is a first in human study of AGS-16M18 given every week to subjects with advanced renal cell cancer. AGS-16M18 will be administered as a 60 minute IV infusion on consecutive days until the disease worsens.
Detailed Description
Subjects will be enrolled sequentially into 5 planned dose cohorts according to a standard, dose escalation study design. A disease assessment will be performed at study week 5 (+/- 3 days) by the investigator. The assessment will be based both on changes in clinical symptoms, and radiographic images. Subjects without evidence of disease progression may receive AGS-16M18 extended therapy at the dose and schedule of their assigned cohort until disease progression or intolerability of AGS-16M18. Disease assessments will be performed every 8 weeks during the extended period. A safety follow-up visit will occur 4 weeks after the last infusion of AGS-16M18.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologic or cytologic diagnosis (recent or remote) of metastatic renal cell carcinoma (including papillary, clear cell, and excluding transitional cell types) that is not amendable to cure by surgery or other means, and must have failed at least one prior systemic therapy, including but not limited to treatment with sunitinib, temsirolimus or sorafenib
- •Evaluable/Measureable disease according to Response Criteria for Solid tumors
- •Eastern Cooperative Group performance status of 0-1
- •Therapeutic anti-coagulation (PT, and/or INR, PTT) permitted, if clinically stable and >/= 3 months from initiation
Exclusion Criteria
- •Past or present documented central nervous system (CNS) tumor or CNS metastasis
- •Use of investigational drug (including marketed drugs not approved for this indication) within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer)
- •History of thromboembolic events and bleeding disorders </= 3 months (e.g., DVT or PE)
- •Major Surgery (that requires general anesthesia) within 4 weeks of study enrollment
Outcomes
Primary Outcomes
Incidence of adverse events
Time Frame: Throughout the treatment
Assessment of PK variables
Time Frame: Weeks 0 - 5, week 8, weekly during extension period, 2 and 3 months after last dose
Secondary Outcomes
- Incidence of anti-AGS-16M18 antibody formation(Week 0, week 1, week 4, week 8, every 8 weeks during extension period, 2 and 3 months after last dose)
- Changes in tumor status(Week 5, week 8, every 8 weeks during extension period)