Study of Safety and Efficacy of HDM201 in Combination With LEE011 in Patients With Liposarcoma

A Phase Ib/II, Open-label, Multicenter Study of Oral HDM201 in Combination With Oral LEE011 in Adult Patients With Liposarcoma

To determine the MTD/RP2D of the HDM201 and LEE011 combination and evaluate whether the combination is safe and has beneficial effects in patients with liposarcoma.

Inclusion Criteria:

• Patients with histologically documented, locally advanced or metastatic WD/DD liposarcoma who have received at least one prior systemic therapy
• Patients with radiologic progression, defined by RECIST v.1.1, occurring while on/or within 6 months after last systemic treatment, prior to enrollment
• ECOG performance status of 0-1

Exclusion Criteria:

• Prior treatment with compounds with the same mode of action
• Patients with TP53 mutated tumors, if the molecular status is known
• Symptomatic central nervous system metastases
• Inadequate organ function
• Previous and concomitant therapy that precludes enrollment, as defined by protocol

Other protocol-defined inclusion/exclusion criteria may apply.