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
To determine the MTD/RDE of PCA062 in patients with pCAD-positive tumors in the dose escalation part.
To characterize the safety and tolerability of PCA062
To characterize the pharmacokinetic profile of PCA062
To assess emergence of anti-PCA062 antibodies following one or more intravenous infusions of PCA062
To assess the preliminary anti-tumor activity of PCA062 in patients with pCAD-positive triple negative breast cancer (TBNC), head and neck squamous cell carcinoma (HNSCC) or esophageal cancer (squamous and adenocarcinoma)