A Rollover Protocol for Subjects Previously Treated With AGS-003

• Status: Terminated
• Trial end date: 2018-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate clinical response to AGS-003 alone or in combination with sunitinib therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Argos Therapeutics

Criteria

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.