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About
This was a phase 1b, multi-arm, open-label study of HDM201 in combination with MBG453 or venetoclax in subjects with AML or high-risk MDS.
For all subjects, TP53wt status had to be characterized by, at a minimum, no mutations noted in exons 5, 6, 7 and 8.
Two treatment arms enrolled subjects in parallel to characterize the safety, tolerability, PK, PD and preliminary antitumor activity of HDM201+MBG453 (treatment arm 1) and HDM201+venetoclax (treatment arm 2).
Upon the completion of the escalation part, MTD(s) and/or RD(s) of HDM201 in combination with MBG453 or venetoclax in AML and high-risk MDS subjects was planned to be determined for each treatment arm.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
Main Inclusion Criteria:
Male or female patients ≥ 18 years of age at the date of ICF signature who present with one of the following:
ECOG performance status ≤ 1
TP53wt tumor. At minimum exons 5, 6, 7 and 8 in the TP53 gene must be sequenced and determined to contain no mutations. The TP53 status must be obtained from a bone-marrow sample, collected no longer than 3 months before signing the main ICF.
Patient must be a candidate for serial bone marrow aspirate and/or biopsy according to the institutional guidelines and be willing to undergo a bone marrow aspirate and/or biopsy at screening, during and at the end of therapy on this study. Exceptions may be considered after documented discussion with Novartis.
Main Exclusion Criteria:
Patients eligible for this study must not meet any of the following criteria:
Prior combination treatment with compounds having the same mode of action:
History of severe hypersensitivity reactions to any ingredient of study drug(s) and other monoclonal antibodies (mAbs) and/or their excipients.
Patients with acute promyelocytic leukemia with PML-RARA.
Allogeneic stem cell transplant (HSCT) within last 6 months and/or active GvHD requiring systemic immunosuppressive therapy.
GI disorders impacting absorption of oral HDM201 or venetoclax.
Evidence of active bleeding or bleeding diathesis or major coagulopathy (including familial).
Patients with active, known or suspected autoimmune disease (treatment arm 1 only).
Other eligibility criteria apply.
Primary purpose
Allocation
Interventional model
Masking
52 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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