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Poster display session

5010 - Ongoing Phase 1 Trial of SL-801, a Novel XPO-1 Inhibitor, in Patients with Advanced Solid Tumors; Interim Results

Date

11 Sep 2017

Session

Poster display session

Topics

Cytotoxic Therapy;  Clinical Research

Presenters

Judy Wang

Citation

Annals of Oncology (2017) 28 (suppl_5): v122-v141. 10.1093/annonc/mdx367

Authors

J. Wang1, J. Nemunaitis2, G. Chiorean3, P. Lorusso4, K. Courtney5, A. Olguin6, J. Bullington7, S. Shemesh7, J. Chen6, C. Brooks8, T.M. Bauer9

Author affiliations

  • 1 Sarah Cannon Research Institute, Florida Cancer Specialists, 34232 - Sarasota/US
  • 2 Mary Crowley Cancer Research Center, Mary Crowley Cancer Research Center, Dallas/US
  • 3 Seattle Cancer Center Alliance, University of Washington, Seattle/US
  • 4 Yale Cancer Center, Yale University, New Haven/US
  • 5 Internal Medicine, UT Southwestern Medical Center, Dallas/US
  • 6 R&d, Stemline Therapeutics, New York/US
  • 7 Clinical Operations, Stemline Therapeutics, New York/US
  • 8 R&d, Stemline Therapeutics, 10022 - New York/US
  • 9 Medical Oncology, Tennessee Oncology, Nashville/US
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Resources

Abstract 5010

Background

Exportin-1 (XPO1) is a critical nuclear export protein involved in nuclear-cytoplasmic transport and is overexpressed in multiple malignancies. SL-801 is a novel oral small molecule inhibitor of XPO1 and has shown potent in vitro and in vivo anti-tumor activity against a broad range of hematologic and solid malignancies. SL-801 has been shown to reversibly inhibit XPO1, which may translate to selective activity and potential safety benefits. Study SL-801-0115 is a first-in-human, dose-escalation study in adult patients with locally advanced, unresectable or metastatic solid tumors that are resistant to or relapsed following available standard systemic therapy. Preliminary interim results in the ongoing dose-escalation Phase 1 clinical study are reported.

Methods

The objective of this multicenter, dose-escalation phase 1 trial is to evaluate the safety and tolerability of SL-801, identify the maximum tolerated dose (MTD), and assess pharmacokinetics (PK) with increasing doses. SL-801 is administered daily on Day 1 through Day 4 and Day 8 through Day 11 every 21 days. The starting dose cohort was 5 mg and has reached 35 mg to date.

Results

As of 3/31/17, 19 heavily pretreated (range: 1-11 prior therapies) adult patients with advanced solid tumors have received SL-801 (6 Females, 13 Males). Median age is 62 years (range: 39-75). MTD has not been reached. Median follow-up is 1.4 months (range: 0.1-4.9). Pharmacokinetic analyses are ongoing. The most frequent treatment-related Grade 1-2 AEs were fatigue and nausea (26%), diarrhea (16%), and myalgia, vomiting and decreased appetite (11% each). Grade 3 AEs, possibly treatment-related, included diarrhea (n = 1; 5 mg) and acute renal injury (n = 1; 30 mg). There were no grade 4 or 5 treatment-related events. Three patients achieved stable disease, for 3-7 cycles, by investigator assessment.

Conclusions

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.

Clinical trial identification

NCT02667873

Legal entity responsible for the study

Stemline Therapeutics

Funding

Stemline Therapeutics

Disclosure

A. Olguin, J. Bullington, S. Shemesh, J. Chen: Stemline Therapeutics: employment, stock options. C. Brooks: Stemline Therapeutics: employment, stock options, patents. All other authors have declared no conflicts of interest.

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