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• W2891494826 abstract "3072 Background: CX-072 is a Pb-Tx directed against programmed cell death ligand 1 (PD-L1), designed to be preferentially activated by tumor-associated proteases but not in healthy tissue. Preclinically, the combination of a PD-1 Pb-Tx with an anti–CTLA-4 antibody showed comparable efficacy but improved safety compared to the non–Pb-Tx combination control. This dose-escalation cohort of CX-072 + ipi in pts with advanced solid tumors was designed to examine the safety and tolerability of combination therapy. Preliminary safety and antitumor activity are reported. Methods: In this ongoing phase 1-2 study (NCT03013491), pts receive CX-072 + ipi in a concomitant dosing schedule (study Part B1). Eligible pts are PD-1, PD-L1, and CTLA-4 inhibitor naive. Planned doses are CX-072 0.3-30 mg/kg IV every 21 days + ipi 3 mg/kg or 10 mg/kg IV every 21 days for 4 cycles, followed by CX-072 monotherapy every 14 days. Results: As of data cut (Nov 30, 2017), part B1 enrolled 9 pts. Median age was 44 years (range, 28-70); 6 pts (67%) were male. Median number of prior anticancer treatments was 4 (range, 2-18). At the time of data cut, 6 pts remained on treatment. Median number of doses of CX-072 (0.3 and 1 mg/ kg) and ipi (3 mg/kg) was 2 (range, 2-10) and 2 (range, 2-4), respectively. 1 DLT (grade 3 dyspnea, 0.3 mg/kg CX-072 + 3 mg/kg ipi) was observed. MTD has not been reached and dose escalation continues. Grade 1-2 treatment-related adverse events (TRAEs) occurred in 6 pts (67%). 4 grade 3 TRAEs were experienced by 2 pts (22%) and included colitis, pneumonitis, and AST and ALT increases (0.3 mg/kg CX-072 + 3 mg/kg ipi). At cutoff, 1 of 4 evaluable pts showed target lesion reduction of 31% from baseline (0.3 mg/kg CX-072, anal SCC, MSI stable, and intermediate tumor mutation burden). As of Dec 4, this patient had a confirmed PR with 56% reduction in target lesion. Conclusions: Preliminary data for CX-072 + ipi show a manageable safety profile and signals of antitumor activity. The study is ongoing, and all cohorts through 10 mg/kg CX-072, the dose selected for monotherapy cohort expansion, are now enrolled. Escalation of ipi dose to 10 mg/kg is pending. Clinical trial information: NCT03013491." @default.
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• W2891494826 date "2018-05-20" @default.
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• W2891494826 title "Preliminary interim results of the first-in-human, dose-finding PROCLAIM-CX-072 trial of the PD-L1 Probody therapeutic (Pb-Tx) CX-072 in combination with ipilimumab (ipi) in patients (pts) with advanced solid tumors." @default.
• W2891494826 doi "https://doi.org/10.1200/jco.2018.36.15_suppl.3072" @default.
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