AN OPEN-LABEL MULTICENTER PHASE 1/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF AB-2100 IN PATIENTS WITH RECURRENT ADVANCED OR METASTATIC CLEAR-CELL RENAL CELL CARCINOMA (CCRCC)
Brief description of study
This is an open-label, multicenter Phase 1/2 study evaluating the safety, efficacy, cellular kinetics, immunogenicity, and pharmacodynamics of AB-2100 in adult subjects with recurrent advanced or metastatic ccRCC. Up to approximately 60 subjects may be treated in the phase 1 portion, including dose escalation and backfill cohorts. Depending on the number of dose-escalation steps and the occurrence of DLTs, the planned number of subjects could vary. In addition, approximately 70 evaluable subjects may be treated in the phase 2 portion of the study, once a RP2D is determined. Conditioning begins on Day -5 and includes 3 days for administration of fludarabine and cyclophosphamide. AB-2100 cells will be administered on Day 0. The phase 1 portion of the study is modular in design, allowing evaluation of the safety, tolerability, cell kinetics, and preliminary anti-tumor activity of one or more versions of AB-2100 in patients with ccRCC (FDA Guidance for Industry). The aim of phase 1 is to define the MTD/MAD of AB-2100 following conditioning, and to establish the RP2D. Successive cohorts of subjects will receive escalating doses of AB-2100 in a 3+3 design. The phase 2 portion will involve a single version of AB-2100 to be evaluated further for efficacy, as measured by objective response rate in subjects with recurrent ccRCC.
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