Proposed Mechanism of Action
NA
Additional Detail
NA
Proposed Mechanism of Action
SERD (ER)
Additional Detail
ELCIN Trial is an open-label multicenter Ph 2 trials of Elacestrant in women and men with CDK4/6 inhibitor naïve ER+/HER2- metastatic breast cancer. The study investigates elacestrant as single agent without prior CDK4/6i exposure.
Proposed Mechanism of Action
SERD (ER)
Additional Detail
ELECTRA Trial is An Open-label Multicenter Phase 1b/2 Study of Elacestrant in Combination with Abemaciclib in Women and Men with Brain Metastasis from Estrogen Receptor positive, HER-2 Negative Breast Cancer. ELECTRA is a Global Study with the aim of determining the activity of elacestrant in combination with Abemaciclib in BC EH+/HER2- with brain metastases.
Proposed Mechanism of Action
SERD (ER)
Additional Detail
ELEVATE Trial is A Phase 1b/2, Open-Label Umbrella Study to Evaluate Safety and Efficacy of Elacestrant in various combination in patients with ER+/HER2- metastatic Breast Cancer. ELEVATE is a Global Study which the aim of determining safety and efficacy of combining elacestrant with other agents in the metastatic setting.
Proposed Mechanism of Action
Targeted Biologic (CD123)
Additional Detail
TAGRAXOFUSP is a novel targeted therapy directed to the IL-3 receptor α (CD123), a target present on a wide range of malignancies including Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN). It comprises human IL-3 recombinantly fused to a truncated diphtheria toxin (DT) payload engineered such that IL-3 replaces the native DT receptor-binding domain. The IL-3 domain of TAGRAXOFUSP directs the cytotoxic DT payload to cells expressing CD123. Upon internalization, TAGRAXOFUSP irreversibly inhibits protein synthesis and induces apoptosis of the target cell. TAGRAXOFUSP was approved by the U.S. FDA in 2018 for the treatment of adult and pediatric patients, 2 years or older, with BPDCN.
Indication
BPDCN
Proposed Mechanism of Action
Targeted Biologic (CD123)
Additional Detail
ELZONRIS was approved by the EMA in 2021 as monotherapy for the first-line treatment of adult patients with BPDCN.
Miami Breast Cancer Conference® (MBCC)
Posters
Elacestrant vs standard-of-care in ER+/HER2- advanced or metastatic breast cancer (mBC) with ESR1 mutation: Key biomarkers and clinical subgroup analyses from the phase 3 EMERALD trial
Product: Orserdu
Bardia A, Shaughnessy JO, Bidard FC, et al
Miami Breast Cancer Conference® (MBCC) March 2024
Poster 10
EMERALD trial analysis of patient-reported outcomes (PROs) in patients with ER+/HER2− advanced or metastatic breast cancer (mBC) comparing oral elacestrant vs standard of care (SoC) endocrine therapy
Product: Orserdu
Cortes J, Bidard FC, Bardia A, et al
Miami Breast Cancer Conference® (MBCC) March 2024
Poster 14
ELECTRA: An open-label, multicenter, phase 1b/2 study of elacestrant in combination with abemaciclib in patients with brain metastasis (mets) from estrogen receptor-positive (ER+), HER2-negative (HER2-) breast cancer (BC)
Product: Orserdu
Ibrahim N, Kim SB, Lin NU, et al
Miami Breast Cancer Conference® (MBCC) March 2024
Poster 25
ELEVATE: A phase 1b/2, open-label, umbrella study evaluating elacestrant in various combinations in patients (pts) with estrogen receptor-positive (ER+), HER2-negative (HER2-) locally advanced or metastatic breast cancer (mBC)
Product: Orserdu
Rugo HS, Bardia A, Hamilton E, et al
Miami Breast Cancer Conference® (MBCC) March 2024
Poster 32
Estimating the direct and indirect resource burden of treatment management with current standard of care or elacestrant for ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer patients: A population-level provider model
Product: Orserdu
Vidal GA, Cinfio F, Badaracco J, et al
Miami Breast Cancer Conference® (MBCC) March 2024
Poster 40
Miami Breast Cancer Conference® (MBCC)
Posters
Elacestrant, an oral selective estrogen receptor degrader (SERD), vs investigator’s choice of endocrine monotherapy for ER+/HER2- advanced/metastatic breast cancer (mBC) following progression on prior endocrine and CDK4/6 inhibitor therapy: Results of EMERALD phase 3 trial
Product: Orserdu
Bardia A, Neven P, Montero AJ, et al
Miami Breast Cancer Conference® (MBCC) March 2022
Poster
American Association for Cancer Research® (AACR)
Posters
Efficacy of novel oral SERD elacestrant in fulvestrant-refractory hormone receptor-positive (HR+) breast cancer: A translational investigation
Product: Orserdu
Dubash TD, Bardia A, Chirn B, et al
American Association for Cancer Research® (AACR) April 2023
Poster CT073
The oral SERD elacestrant in combination with the PI3K inhibitor MEN1611 inhibits tumor growth in ER+/HER2- breast cancer in vitro and in PDX models
Product: Orserdu
Merlino G, Fiascarelli A, Talucci S, et al
American Association for Cancer Research® (AACR) April 2023
Poster 2849
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Pipeline and Clinical Trials
At Stemline Therapeutics, we are committed to applying our scientific leadership to transform the lives of people with cancer. We are focused on the development of a broad pipeline of innovative, transformative therapies in oncology.
Stemline Pipeline
Clinical Trials
Hematology
Tagraxofusp | Anti-CD123
|
REGIMEN PATIENT POPULATION |
TRIAL | PHASE |
|---|---|---|
|
Monotherapy R/R AML |
NCT02113982 |  |
|
+ Venetoclax + azacitidine 1L unfit CD123+ AML |
NCT06456463 |  |
|
Monotherapy High-risk 1L or R/R CMML or R/R MF |
NCT02268253 | |
MEN1703 | PIM/FLT3 inhibitor
|
REGIMEN PATIENT POPULATION |
TRIAL | PHASE |
|---|---|---|
|
+ Glofitamab R/R DLBCL |
JASPIS-01 NCT06534437 f |
|
Tagraxofusp | Anti-CD123
REGIMEN | PATIENT POPULATION
Monotherapy | R/R AML
TRAIL
NCT02113982
PHASE
REGIMEN | PATIENT POPULATION
+ Venetoclax + azacitidine 1L unfit CD123+ AML
TRAIL
NCT06456463
PHASE
REGIMEN | PATIENT POPULATION
Monotherapy
High-risk 1L or R/R CMML or R/R MF
TRAIL
NCT02268253
PHASE
MEN1703 | PIM/FLT3 inhibitor
REGIMEN | PATIENT POPULATION
+ Glofitamab
R/R DLBCL
TRAIL
JASPIS-01 | NCT06534437f
PHASE
Solid Tumors
Elacestrant | SERD
|
REGIMEN PATIENT POPULATION |
TRIAL | PHASE |
|---|---|---|
|
Monotherapy ER+/HER2− eBC with high risk of recurrence |
ELEGANT NCT06492616 |
 |
|
+ Everolimus ER+/HER2−, ESR1-mut advanced BC with progression on ET + CDK4/6i |
ADELA* NCT06382948a *This is a global study with no US trial sites. |
|
|
+ Alpelisib, everolimus, capivasertib, ribociclib, palbociclib, or abemaciclib ER+/HER2− mBC |
ELEVATE NCT05563220 |
|
|
+ Abemaciclib ER+/HER2− mBC with brain metastases |
ELECTRA NCT05386108 |
|
|
Monotherapy CDK4/6i-naive ER+/HER2− mBC |
ELCIN NCT05596409 |
|
|
+ Samuraciclib ER+/HER2− locally advanced or mBC |
SUMIT-ELA NCT05963997b |
|
|
Monotherapy ER+/HER2− eBC with ctDNA relapse |
TREAT ctDNA NCT05512364c |
|
|
+ Olaparib HR+/HER2− a/mBC with g/tBRCA1/2 mutations |
ELEMENT NCT06201234d |
|
MEN1611 | PI3Ki δ sparing
|
REGIMEN PATIENT POPULATION |
TRIAL | PHASE |
|---|---|---|
|
+ Trastuzumab ± fulvestrant PIK3CA-mut, HER2+ advanced or mBC |
B-PRECISE-01 NCT03767335 |
|
MEN2312 | KAT6 inhibitor
|
REGIMEN PATIENT POPULATION |
TRIAL | PHASE |
|---|---|---|
| Mono- and combination therapy |  |
MEN1611 | PI3Ki δ sparing
|
REGIMEN PATIENT POPULATION |
TRIAL | PHASE |
|---|---|---|
|
+ Cetuximab Metastatic colorectal cancer |
C-PRECISE-01 NCT04495621 |
|
SL-701 | IL-13Rα2, EphA2, survivin
|
REGIMEN PATIENT POPULATION |
TRIAL | PHASE |
|---|---|---|
|
+ Bevacizumab Recurrent glioblastoma multiforme |
NCT02078648 | |
MEN1309 | Anti-CD205 ADC
|
REGIMEN PATIENT POPULATION |
TRIAL | PHASE |
|---|---|---|
|
Monotherapy CD205+ recurrent or metastatic solid tumors |
NCT04064359e | |
Felezonexor | XPO1 inhibitor
|
REGIMEN PATIENT POPULATION |
TRIAL | PHASE |
|---|---|---|
|
Monotherapy Advanced solid tumors |
NCT02667873 | |
Solid Tumors
Elacestrant | SERD
REGIMEN | PATIENT POPULATION
Monotherapy | ER+/HER2− eBC with high risk of recurrence
TRAIL
ELEGANT | NCT06492616
PHASE
REGIMEN | PATIENT POPULATION
+ Everolimus | ER+/HER2−, ESR1-mut advanced BC with progression on ET + CDK4/6i
TRAIL
ADELA* | NCT06382948a
*This is a global study with no US trial sites.
PHASE
REGIMEN | PATIENT POPULATION
+ Alpelisib, everolimus, capivasertib, ribociclib, palbociclib, or abemaciclib | ER+/HER2− mBC
TRAIL
ELEVATE | NCT05563220
PHASE
REGIMEN | PATIENT POPULATION
+ Abemaciclib | ER+/HER2− mBC with brain metastases
TRAIL
ELECTRA | NCT05386108
PHASE
REGIMEN | PATIENT POPULATION
Monotherapy | CDK4/6i-naive ER+/HER2− mBC
TRAIL
ELCIN | NCT05596409
PHASE
REGIMEN | PATIENT POPULATION
+ Samuraciclib | ER+/HER2− locally advanced or mBC
TRAIL
SUMIT-ELA | NCT05963997b
PHASE
REGIMEN | PATIENT POPULATION
Monotherapy | ER+/HER2− eBC with ctDNA relapse
TRAIL
TREAT ctDNA | NCT05512364c
PHASE
REGIMEN | PATIENT POPULATION
+ Olaparib | HR+/HER2− a/mBC with g/tBRCA1/2 and/or g/tPALB2 mutations
TRAIL
ELEMENT | NCT06201234d
PHASE
MEN1611 | PI3Ki δ sparing
REGIMEN | PATIENT POPULATION
+ Trastuzumab ± fulvestrant | PIK3CA-mut, HER2+ advanced or mBC
TRAIL
B-PRECISE-01 | NCT03767335
PHASE
MEN2312 | KAT6 inhibitor
REGIMEN | PATIENT POPULATION
Mono- and combination therapy
TRAIL
PHASE
REGIMEN | PATIENT POPULATION
+ Cetuximab | Metastatic colorectal cancer
TRAIL
C-PRECISE-01 | NCT04495621
PHASE
SL-701 | IL-13Rα2, EphA2, survivin
REGIMEN | PATIENT POPULATION
+ Bevacizumab | Recurrent glioblastoma multiforme
TRAIL
NCT02078648
PHASE
MEN1309 | Anti-CD205 ADC
REGIMEN | PATIENT POPULATION
Monotherapy | CD205+ recurrent or metastatic solid tumors
TRAIL
NCT04064359e
PHASE
Felezonexor | XPO1 inhibitor
REGIMEN | PATIENT POPULATION
Monotherapy | Advanced solid tumors
TRAIL
NCT02667873
PHASE
The information in the table reflects the development pipeline and is not intended for promotional or marketing purposes. The safety and efficacy of the investigational compounds, or investigational uses of marketed products have not been established and marketing approval has yet to be granted by regulatory authorities.
1L: first-line; ADC: antibody drug conjugate; adv: advanced; a/mBC: advanced or metastatic BC; AML: acute myeloid leukemia; BC: breast cancer; CD123: interleukin-3 receptor; CDK4/6i: cyclin-dependent kinase 4/6 inhibitor; CMML: chronic myelomonocytic leukemia; DLBCL: diffuse large B-cell lymphoma; eBC: early breast cancer; EphA2: ephrin receptor A2; ER+: estrogen receptor-positive ESR1: estrogen receptor 1; ET: endocrinetherapy; HER2−:humanepidermalgrowthfactor receptor2-negative; HR+: hormonereceptor-positive; IL-13Rα2: interleukin-13receptor subunitalpha2; IND: Investigationalnew drug; KAT6i: K(lysine)acetyltransferase 6 inhibitor; mBC: metastatic breastcancer; MF: myelofibrosis; MOA: mechanismofaction; mut:mutant; PI3Ki: phosphoinositide3 kinaseinhibitor; PIK3CA: phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha; R/R: relapsed or refractory; SERD: selective estrogen receptor degrader; XPO1: exportin 1.
Clinical trial collaboration with: aMEDSIR; bCarrick Therapeutics; cInvestigator initiated clinical study sponsored by EORTC; dInvestigator initiated clinical study sponsored by German Breast Group; eClinical development partnered with Oxford BioTherapeutics; fRyvu Therapeutics S.A. sponsored study.
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- Summary & Overview
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Summary
Phase 2, Phase 1
(Adult, Older Adult )
Enrollment ()
Study type
Location
Study Start
Primary Completion
Study Completion
Overview
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Clinical Trial Cards
Elacestrant in women and men with CDK4/6 inhibitor-naive ER+/HER2− metastatic breast cancer: An open-label multicenter Phase 2 study
Valid Till: 15-10-2026
An open-label multicenter Phase 1b/2 study of elacestrant in combination with abemaciclib in women and men with brain metastasis from ER+/HER2− breast cancer
Valid Till: 15-10-2026
A Phase 3 study of elacestrant ± everolimus in patients with ESR1-mut ER+/HER2– mBC who progressed on prior ET + CDK4/6i
Valid Till: 21-11-2026
A randomized Phase 3 study of elacestrant vs standard ET in patients with ER+/HER2− eBC with a high risk of recurrence
Valid Till: 11-10-2026
Phase III ELEGANT Study Design Summary
Valid Till: 25-02-2027
Acute Myeloid Leukemia Clinical Trial Overview.Triplet Therapy.November 2024
Valid Till: 08-11-2026
A Phase 1b/2, open-label umbrella study to evaluate safety and efficacy of elacestrant in various combinations in patients with metastatic breast cancer
Valid Till: 15-10-2026
A Phase 1b/2 open-label study of samuraciclib in combination with elacestrant in participants with metastatic or locally advanced HR+/HER2− breast cancer
Valid Till: 18-10-2026
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