HDM201

DRUG11 trials

Sponsors

Centre Leon Berard, Novartis Pharma Services AG, Novartis Pharmaceuticals, Insel Gruppe AG, University Hospital Bern

Conditions

AML, AdultAcute Myeloid Leukemia (AML)Advanced / metastatic cancersAdvanced CancerAdvanced Soft-tissue SarcomaAdvanced Solid and Hematological TP53wt TumorsColorectal CancerColorectal Cancer, Non-small Cell Lung Carcinoma (Adenocarcinoma), Triple Negative Breast Cancer, Renal Cell Carcinoma

Phase 1

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

CompletedNCT02143635

Novartis PharmaceuticalsAdvanced Solid and Hematological TP53wt Tumors

Start: 2014-07-07End: 2020-06-09Updated: 2021-05-21

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

CompletedNCT02343172

Novartis PharmaceuticalsLiposarcoma

Start: 2015-03-13End: 2019-10-16Updated: 2020-12-09

A Study of PDR001 in Combination With LCL161, Everolimus or Panobinostat

CompletedNCT02890069

Novartis PharmaceuticalsColorectal Cancer, Non-small Cell Lung Carcinoma (Adenocarcinoma), Triple Negative Breast Cancer, Renal Cell Carcinoma

Start: 2016-10-14End: 2022-02-22Updated: 2023-01-11

Trametinib + HDM201 in CRC Patients With RAS/RAF Mutant and TP53 Wild-type Advanced/Metastatic Colorectal Cancer Mutant and TP53 Wild-type

CompletedNCT03714958

Centre Leon BerardAdvanced Cancer, Colorectal Cancer, Metastatic Cancer

Start: 2018-12-20End: 2023-09-12Updated: 2023-09-13

HDM201 Added to CT in R/R or Newly Diagnosed AML

WithdrawnNCT03760445

Novartis PharmaceuticalsLeukemia, Myeloid, Acute

Start: 2019-11-15End: 2023-06-13Updated: 2020-01-09

HDM201 in Combination With MBG453 or Venetoclax in Patients With Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (MDS)

TerminatedNCT03940352

Novartis PharmaceuticalsAcute Myeloid Leukemia (AML), High-risk Myelodysplastic Syndrome (MDS)

Start: 2019-06-24End: 2024-08-20Updated: 2025-10-10

HDM201 and Midostaurin (HDMM) in Relapsed/Refractory AML With FLT3mut and TP53wt.

TerminatedNCT04496999

Insel Gruppe AG, University Hospital BernAML, Adult

Start: 2020-07-13End: 2022-09-09Updated: 2022-10-06

HDM201 and Pazopanib in Patients With P53 Wild-type Advanced/Metastatic Soft Tissue Sarcomas

Active, not recruitingNCT05180695

Centre Leon BerardAdvanced Soft-tissue Sarcoma, Metastatic Soft-tissue Sarcoma

Start: 2022-04-15End: 2027-02-01Updated: 2026-02-10

Phase 2

A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors.

RecruitingNCT04116541

Centre Leon BerardMalignant Solid Tumor

Start: 2020-01-28End: 2026-11-30Target: 455Updated: 2025-11-21

MegaMOST - A multicenter, open-label, biology driven, Phase II study evaluating the activity of anti-cancer treatments targeting tumor molecular alterations/characteristics in advanced / metastatic tumors

RecruitingCTIS2023-510567-35-00

Centre Leon BerardAdvanced / metastatic cancers

Start: 2020-06-10Target: 455Updated: 2026-01-08

Phase 4

An open label, multi-center, Phase IV rollover protocol for patients who have completed a prior global Novartis or Incyte sponsored ruxolitinib (INC424) study or a study of ruxolitinib in combination with either panobinostat (LBH589) or siremadlin (HDM201) or rineterkib (LTT462), and are judged by the investigator to benefit from continued treatment

Active, not recruitingCTIS2024-515283-31-00

Novartis Pharma Services AGdepending on the parent protocol, This study is designed to accept patients with varied disease origins

Start: 2015-07-30Target: 33Updated: 2025-12-09

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