In this first-in-human study of the pan-BET inhibitor mivebresib (ABBV-075), the safety profile, MTD, and recommended phase II dose (RP2D) were determined in patients with advanced solid tumors.
<b>Purpose:</b> This phase Ib study was designed to determine the MTD, safety, preliminary efficacy, and pharmacokinetics of the HER3 (ErbB3) mAb SAR256212 in combination with the oral PI3K inhibitor SAR245408 for patients with metastatic or locally advanced solid tumors.<b>Experimental Design:</b> Patients received the combination of intravenous SAR256212 and oral SAR245408 in a 3 + 3 dose-escalation design until occurrence of disease progression or dose-limiting toxicity.
This Phase I study determined the MTD, pharmacokinetics (PK) and antitumor activity of ONT-380 in HER2-positive advanced solid tumors, with an expansion cohort of patients with HER2<sup>+</sup> MBC.<b>Experimental Design:</b> ONT-380 was administered twice daily (BID) in continuous 28-day cycles.
This phase I-II study was the first to evaluate single-agent oral rucaparib at multiple doses.<b>Experimental Design:</b> Part 1 (phase I) sought to determine the MTD, recommended phase II dose (RP2D), and pharmacokinetics of oral rucaparib administered in 21-day continuous cycles in patients with advanced solid tumors.
<b>Purpose:</b> To determine the MTD and to assess the safety, tolerability, and potential activity of LB-100, a first-in-class small-molecule inhibitor of protein phosphatase 2A (PP2A) in adult patients with progressive solid tumors.<b>Experimental Design:</b> LB-100 was administered intravenously daily for 3 days in 21-day cycles in a 3 + 3 dose escalation design.<b>Results:</b> There were 29 patient entries over 7 dose escalations.
<b>Purpose:</b> To evaluate the safety, MTD, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of TAK-117 (MLN1117/INK1117), an investigational PI3Kα-selective inhibitor, in patients with advanced solid tumors.<b>Experimental Design:</b> Seventy-one patients received oral TAK-117 once daily [100-300 mg (<i>n</i> = 24)] or 3 days per week [Monday-Wednesday-Friday (MWF), 200-1,200 mg (<i>n</i> = 27); Monday-Tuesday-Wednesday (MTuW), 200-900 mg (<i>n</i> = 20)], in 21-day cycles.