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HDM201

Phase 1

Advanced Solid and Hematological TP53wt Tumors | Small molecule | Oncology |Novartis AG|Last Updated: May 21, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment208
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02143635Study to Determine and Evaluate a Safe and Tolerated Dose of HDM201 in Patients With Selected Advanced Tumors That Are TP53wtPHASE1 COMPLETED 208Jul 7, 2014Jun 9, 2020May 21, 202115 United States, France +6
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Study Endpoints
Primary Endpoints
Incidence of dose limiting toxicities (DLTs)
up to 28 days

DLTs in the first cycle of treatment.

Secondary Endpoints
Number of patients with adverse events (AEs)
For the duration of treatment, an average of 16 weeks
Pharmacokinetics (PK) parameters of HDM201
Up to 42 days
Changes from baseline of Pharmacodynamics markers
Baseline, up to 28 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm AEXPERIMENTAL -
Arm BEXPERIMENTAL -
Arm CEXPERIMENTAL -
Arm DEXPERIMENTAL -
Interventions
NameTypeDescription
HDM201DRUG -
ancillary treatmentDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites15

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 a...

Countries:United StatesFranceGermanyJapanNetherlandsSingaporeSpainTaiwan
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