The primary objective of this study is:
to evaluate the efficacy and safety of luspatercept for the treatment of anemia in subjects
with MPN-associated myelofibrosis with and without RBC-transfusion dependence.
To evaluate the efficacy of niraparib in combination with bevacizumab, as assessed by 18-month progression-free survival (PFS) landmark analysis, in patients with Stage IIIB to IV ovarian cancer who have complete response (CR), partial response (PR), or no evidence of disease (NED) following front-line, platinum-based chemotherapy with bevacizumab
To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral TP-0903 administered daily for the first 21 days every 4 weeks, over a range of doses in patients with advanced solid tumors.
To establish the pharmacokinetics of orally administered TP-0903
To observe patients for any evidence of antitumor activity of TP-0903 by objective radiographic assessment
To study the pharmacodynamics of TP-0903 therapy by:
assessing biomarkers in tumor tissue
assessing biomarkers in peripheral blood mononuclear cells (PBMCs) and serum
To establish the Recommended Phase 2 Dose (RP2D) for future studies with TP-0903
Phase I part
To estimate the RP2D or MTD for the single agent LAG525 and the combination of LAG525 and PDR001.
Phase II part
To estimate the overall response rate per RECIST V1.1 for single agent LAG525 as well as for the combination of LAG525 and PDR001
To characterize the safety and tolerability of single agent LAG525 given alone and in combination with PDR001
To characterize the pharmacokinetic profile of single agent LAG525 given alone and in combination with PDR001
To assess emergence of anti-LAG525, and anti-PDR001 antibodies following one or more intravenous (i.v.) infusions of single agent LAG525 given alone or in combination with PDR001
To assess potential predictors of efficacy of single agent LAG525 and the combination of LAG525 and PDR001
To evaluate the preliminary antitumor activity of single agent LAG525 given alone or in combination of PDR001
To investigate patient selection and pharmacodynamic biomarkers in tumor tissue samples