Clinical trial · Interventional
A Rollover Protocol for Subjects Previously Treated With AGS-003
A Rollover Phase II Study Testing the Biologic Activity and Safety of AGS-003 in Renal Cell Carcinoma Subjects With Prolonged Response or Stable Disease and Ongoing AGS-003 Treatment in Protocol AGS-003-004 or AGS-003-006
NCT01482949CI-TRIAL-00033479terminatedPhase 2ClinicalTrials.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): Lack of efficacy
Summary
Brief summary (as posted)
The purpose of this study is to evaluate clinical response to AGS-003 alone or in combination with sunitinib therapy.
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 |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AGS-003 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AGS-003 in combination with sunitinib
- description
- Subjects will undergo Induction (AGS-003 every 3 weeks until 5 doses are administered) followed by Booster (AGS-003 at 3 month intervals). Subjects that will begin sunitinib therapy will be on this arm.
- interventionNames
- Drug: AGS-003
Primary outcomes (1)
- measure
- Tumor response
- timeFrame
- From date of registration until either disease progression, meeting a discontinuation criterion, or death; assessed up to 36 months.
- description
- Clinical antitumor activity of AGS-003 will be assessed as an objective tumor response by Response Evaluation Criteria in Solid Tumors (RECIST).
Secondary outcomes (11)
- measure
- Clinical benefit (stable disease or response)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * Subjects are receiving ongoing treatment with AGS-003 in protocol AGS- 003-004 or AGS-003-006. * Measurable disease that can be monitored per RECIST throughout the course of study participation. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate hematologic function, as defined by the following criteria: 1. White blood cell (WBC) ≥ 4000/µL (≥ 4.0 x 103/µL) 2. Absolute neutrophil count (ANC) ≥ 1500/µL (≥ 1.5 x 103/µL) 3. Platelets ≥ 100,000/µL (≥ 100 x 103/µL) 4. Hemoglobin (Hgb) ≥ 9.0 g/dL * Adequate renal and hepatic function, as defined by the following criteria: 1. Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or, if serum creatinine \> 1.5 x ULN, estimated glomerular filtration rate (eGFR) ≥ 30 mL/min 2. Total serum bilirubin ≤ 1.5 x ULN 3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN, or AST and ALT ≤ 5 x ULN if liver function abnormalities are due to underlying malignancy * Adequate coagulation function as defined by the following criteria: 1. Prothrombin time (PT) ≤ 1.5 x ULN 2. Activated partial thromboplastin time (PTT) \< 1.5 x ULN 3. Corrected calcium ≤ 11.5 mg/dL * Negative serum pregnancy test for female subjects with reproductive potential, and agreement of all male and female subjects of reproductive potential to use a reliable form of contraception during the study and for 12 weeks after the last dose of study drug * Able to abstain from taking prohibited drugs, either prescription or non- prescription, during the treatment phase of the study * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures * Signed and dated informed consent document indicating that the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment * No brain metastases detected by magnetic resonance imaging (MRI). Exclusion Criteria: * Any serious medical condition considered by the investigator to constitute an unwarranted high risk for investigational treatment * History of or known brain metastases, spinal cord compression, or carcinomatous meningitis, or evidence of brain or leptomeningeal disease on screening computed tomography (CT) scan or MRI * Pregnancy or breastfeeding * Active autoimmune disease or condition requiring chronic immunosuppressive therapy NOTE: Abnormal laboratory values for autoimmunity markers in the absence of other signs/symptoms of autoimmune disease are not exclusionary.
References
Publications (0)
Data not yet available
No reference posted for this study.