Clinical trial · Interventional
A Phase 1 Study of the Safety and Pharmacokinetics of AGS-16M18 in Subjects With Advanced Renal Cell Cancer
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
NCT00816686CI-TRIAL-00009577terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Trial was terminated due to the need to re-formulate the study drug.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Renal Cell | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Kidney Diseases | — | UNRESOLVED | — |
| Kidney Neoplasms | Kidney Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AGS-16M18 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- 1. AGS-16M18 Dose 1
- interventionNames
- Biological: AGS-16M18
- type
- EXPERIMENTAL
- label
- 2. AGS-16M18 Dose 2
- interventionNames
- Biological: AGS-16M18
- type
- EXPERIMENTAL
- label
- 3. AGS-16M18 Dose 3
- interventionNames
- Biological: AGS-16M18
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.