Study to Determine and Evaluate a Safe and Tolerated Dose of HDM201 in Patients With Selected Advanced Tumors That Are TP53wt

• Status: Completed
• Trial end date: 2020-06-09
• Target enrollment: 0
• Participant gender: All

Summary

To determine and evaluate a safe and tolerated dose of HDM201 in adult patients with selected advanced tumors characterized by wild-type TP53.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

Inclusion Criteria:

• Patient with a TP53wt locally advanced or metastatic solid malignancy and with measurable or non-measurable (but evaluable) disease as determined by RECIST 1.1 criteria.

• Patients with the TP53wt hematological tumors (AML, ALL, HR-MDS) who have failed prior therapies or who are considered inappropriate candidates for standard induction therapy.

Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

• Prior treatment with compounds with the same mode of action

• Subjects with significant or uncontrolled cardiovascular disease

• History of thromboembolic or cerebrovascular events within the last 6 months, including transient ischemic attack, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism

• Previous and concomitant therapy that precludes enrollment, as defined in the protocol

• Known Human Immunodeficiency Virus (HIV) infection and/or active Hepatitis B or Hepatitis C infection

• Patients who have undergone major surgery within the 2 weeks prior to starting study treatment or who have not fully recovered from previous surgery

• Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 2 weeks after study drug discontinuation

• Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply