felezonexor (CBS9106) / CanBas, Menarini - LARVOL DELTA

A Phase 1 Trial of a Novel XPO1 Inhibitor in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=72 | Completed | Sponsor: Stemline Therapeutics, Inc. | Terminated ➔ Completed

Metastases • Trial completion • Gastrointestinal Cancer • Oncology • Solid Tumor

Ongoing phase 1 trial of SL-801, a novel XPO-1 inhibitor, in patients with advanced solid tumors; Interim results (ESMO 2017) - P1; "The initial dose-escalation of SL-801 appears to be well tolerated to date in patients with advanced solid malignancies. Enrollment continues in this ongoing Phase 1 trial and updated safety and efficacy data will be presented. Clinical trial information: NCT02667873."

P1 data • Solid Tumor

A Phase 1 Trial of a Novel XPO1 Inhibitor in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=72 | Terminated | Sponsor: Stemline Therapeutics, Inc. | Trial completion date: Jun 2022 ➔ Jan 2022 | Recruiting ➔ Terminated; Enrollment completed

Trial completion date • Trial termination • Gastrointestinal Cancer • Oncology • Solid Tumor

Interim results from trial of SL-801, a novel XPO-1 inhibitor, in patients with advanced solid tumours (ESMO 2019) - P1; "SL-801 reversibly binds XPO1, a clinically validated target in oncology. To date 27% of heavily pre-treated patients have achieved SD as best response. Enrollment and dose escalation continue."

Clinical • Hematological Malignancies • Oncology

[VIRTUAL] Updated results of a phase I study of Felezonexor (SL-801), a novel XPO-1 reversible inhibitor, in patients with relapsed/refractory solid tumours (ESMO 2020) - P1 | "Funding: Stemline Therapeutics, Inc. Clinical trial identification: NCT02667873."

Clinical • IO biomarker • P1 data • Basal Cell Carcinoma • Colorectal Cancer • Gastrointestinal Cancer • Hematological Malignancies • Multiple Myeloma • Oncology • Solid Tumor • BIRC5 • CCND1 • KRAS

Interim Results from a Phase 1 Trial of SL-801, a Novel XPO-1 Inhibitor, in Patients with Advanced Solid Tumors (ESMO 2018) - P1; "SL-801 appears to be well tolerated in advanced solid tumor patients, and to date 23% of heavily pre-treated patients have achieved SD as best response. Enrollment and dose escalation continue."

Clinical • P1 data • Breast Cancer • Gastrointestinal Cancer

Interim results from a phase 1 trial of SL-801, a novel XPO-1 inhibitor, in patients with advanced solid tumors. (ASCO 2018) - P1; "SL-801 appears to be well tolerated in advanced solid tumor patients, and 29% of patients achieved SD as best reponse. Enrollment and dose escalation continue in an effort to identify an optimal dose and regimen."

Clinical • P1 data • Breast Cancer

A Phase 1 Trial of a Novel XPO1 Inhibitor in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=70; Recruiting; Sponsor: Stemline Therapeutics, Inc.; Trial completion date: Jun 2021 ➔ Jun 2022; Trial primary completion date: Dec 2020 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Gastrointestinal Cancer • Oncology • Solid Tumor

Stemline Therapeutics announces SL-701 and SL-801 clinical data to be featured, including an oral presentation, at upcoming ESMO 2018 Congress (GlobeNewswire) - "Stemline Therapeutics...announced...that clinical data from its SL-701 and SL-801 trials have been selected for presentation, including an oral presentation, at the upcoming European Society of Medical Oncology (ESMO) Annual Congress 2018 to be held from October 19-23, in Munich, Germany. The details of the data presentations...Results of Phase II Trial Of SL-701, a Novel Immunotherapy Targeting IL-13Ra2, Epha2, and Survivin, in Adults with Second-Line Recurrent Glioblastoma (GBM)....Interim Results from a Phase 1 Trial of SL-801, a Novel XPO-1 Inhibitor, in Patients with Advanced Solid Tumors."

P1 data • P2 data • Brain Cancer • Glioblastoma • Oncology • Solid Tumor

[VIRTUAL] Updated results of a phase I study of felezonexor (SL-801), a novel XPO-1 reversible inhibitor, in adult patients with relapsed/refractory solid tumors. (ASCO 2020) - No abstract available

Clinical • P1 data • Oncology • Solid Tumor

A Phase 1 Trial of a Novel XPO1 Inhibitor in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=70; Recruiting; Sponsor: Stemline Therapeutics, Inc.; Trial completion date: Jun 2020 ➔ Jun 2021; Trial primary completion date: Dec 2019 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date

Stemline Therapeutics Recaps Felezonexor (SL-801) Clinical Data Presentation From ESMO 2019 Congress (GlobeNewswire, Stemline Therapeutics, Inc.) - "NEW YORK, Oct 01, 2019 (GLOBE NEWSWIRE) -- Stemline Therapeutics...presented updated clinical data on the felezonexor (SL-801) Phase 1 trial in patients with advanced solid tumors at the European Society of Medical Oncology (ESMO) 2019 Annual Congress in Barcelona, Spain...Partial response (PR) achieved with single agent felezonexor in a 4th line patient with KRAS-positive, microsatellite stable (MSS) colorectal cancer (18+ weeks, ongoing)...Stable disease (SD) achieved in 12 patients, with 11/12 of these patients 3rd line or greater"

Clinical data • Preclinical • Regulatory

Stemline Therapeutics Announces Felezonexor (SL-801) Clinical Data to be Featured at Upcoming ESMO 2019 Congress (GlobeNewswire, Stemline Therapeutics, Inc.) - "Stemline Therapeutics, Inc (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, today announced that clinical data on felezonexor (SL-801) has been selected for presentation at the upcoming European Society of Medical Oncology (ESMO) Annual Congress 2019 to be held from September 25-30, in Barcelona, Spain. Interim Results from a Phase 1 Trial of SL-801, a Novel XPO-1 Inhibitor, in Patients with Advanced Solid Tumors."

Clinical data

Stemline Therapeutics reports second quarter 2019 financial results (GlobeNewswire) - “Commercial: Net revenue of ELZONRIS were $13.0 million during the second quarter, representing a 157% increase over last quarter; Stemline continues to advance its clinical stage assets, including SL-801 (felezonexor), a reversible inhibitor of XPO1. Updated Phase 1 data were selected for presentation at the upcoming European Society for Medical Oncology (ESMO) meeting. Stemline is also developing its preclinical assets SL-1001 (RET kinase inhibitor) and SL-901 (kinase inhibitor), both of which are in IND-enabling studies and are expected to enter the clinic next year.”

P1 data • Preclinical • Sales

Stemline Therapeutics reports first quarter 2019 financial results (GlobeNewswire) - “First Quarter 2019 Financial Results Review: Net revenue for ELZONRIS was $5.05 million for the quarter ended March 31, 2019; ELZONRIS™ (tagraxofusp) – Blastic plasmacytoid dendritic cell neoplasm (BPDCN): We submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in January 2019 seeking marketing approval in Europe. The MAA was granted accelerated assessment and is currently under review; Other pipeline candidates: We expect to provide periodic updates on our other product candidates, SL-701, SL-801…later this year.”

Clinical data • European regulatory • Sales

A Phase 1 Trial of a Novel XPO1 Inhibitor in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1; N=70; Recruiting; Sponsor: Stemline Therapeutics, Inc.; N=50 ➔ 70; Trial completion date: Dec 2019 ➔ Jun 2020; Trial primary completion date: Jun 2019 ➔ Dec 2019

Clinical • Enrollment change • Trial completion date • Trial primary completion date