A Study Of PF-05082566 As A Single Agent And In Combination With Rituximab (NCT01307267) | Clinical Trial Compass
CompletedPhase 1
A Study Of PF-05082566 As A Single Agent And In Combination With Rituximab
United States190 participantsStarted 2011-06-21
Plain-language summary
A study of PF-05082566, a 4-1BB agonist monoclonal antibody (mAb), in patients with solid tumors or b-cell lymphomas, and in combination with rituximab in patients with CD20 positive Non-Hodgkin's Lymphoma (NHL).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria
* Portion A: Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy or B cell lymphoma, for which no curative therapy is available. Portion A expansion includes patients who have documented disease progression on a checkpoint inhibitor (anti CTLA 4, anti PD1/PD L1 antibodies) per RECIST criteria. Tumor types include metastatic melanoma, renal cell carcinoma (RCC), non-small cell lung cancer (NCSLC) and squamous cell carcinoma of the head and neck (SCCHN). Patients in the dose expansion stage are required to provide archival or baseline (obtained during the screening period) tumor biopsies.
* Portion B: Histological confirmed relapsed or refractory CD20 positive NHL for which no curative therapy is available. Patients enrolled in the expansion cohort must have archival tissue available, sampled within 6 months of study entry. The Expansion cohort includes patients with FL or DLBCL with relapsed or refractory disease.
* Measurable disease with at least one extranodal tumor mass \>1.0 cm in the greatest transverse diameter (GTD) or in the case of malignant lymph nodes \>1.5 cm in the GTD.
* ECOG performance status of ≤ 1.
* Adequate bone marrow function, for Portion A: absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelet count ≥100 x 109/L, hemoglobin \>9.0 g/dL. For Portion B: ANC ≥ 1.0 x 109/L, platelet count ≥ 75 x 109/L, and hemoglobin ≥ 8.0 g/dL. In both cases, patients must be transfusion independent at least 14 days prio…
What they're measuring
1
Number of Participants With Dose-Limiting Toxicities (DLTs) in First 2 Cycles of Portion A
Timeframe: Cycle 1 Day 1 to Cycle 2 Day 29 in Portion A (up to 57 days, each cycle = 28 days)
2
Number of Participants With DLTs in First 2 Cycles of Portion B
Timeframe: Cycle 1 Day 1 to Cycle 2 Day 29 in Portion B (up to 57 days, each cycle = 28 days)