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Study of the PI3K Inhibitor SL-901 in Patients With Advanced Solid Tumors With Advanced Solid Tumors

Sponsor
Stemline Therapeutics, Inc. (Other)
Overall Status
Recruiting
CT.gov ID
NCT05382936
Collaborator
(none)
60
Enrollment
2
Locations
2
Arms
32.4
Anticipated Duration (Months)
30
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study STML-901-0119 is a dose-escalation study evaluating multiple doses and schedules of orally administered SL-901 in patients with Advanced Solid Tumors.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

Study STML-901-0119 is a multi-center, open-label, dose-escalation and regimen-finding study aimed to investigate the safety, PK, and PD of SL-901 in patients with advanced solid tumors.

Part 1a will take place in up to 5 centers in the United Kingdom and follow a 3+3 dose-escalation design to determine the maximum tolerated dose of SL-901 when administered on both a QD and BID schedule. Eligible patients will be enrolled and receive treatment with SL-901 daily on a 28-day cycle. SL-901 will be administered orally and the dose regimen will depend on the cohort and regimen in which the patient is enrolled.

Part 1b will utilize the selected dose from Part 1a, and the clinical activity of SL-901 will be evaluated in patients with advanced solid tumors known to have specific genetic alterations, who may derive benefit from treatment with a phosphoinositide 3-kinase (PI3K) inhibitor.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Patients will be assigned to the QD or BID regimen based on cohort assignment.Patients will be assigned to the QD or BID regimen based on cohort assignment.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1, Open-label, Dose-escalation Study of the PI3K Inhibitor SL-901 in Patients With Advanced Solid Tumors
Actual Study Start Date :
Mar 19, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: QD Regimen

Patients in the QD regimen will take study medication once daily.

Drug: SL-901
Patients will take study medication daily, with dosage based on their assigned cohort and regimen.
Experimental: BID Regimen

Patients in the BID regimen will take study medication twice daily.

Drug: SL-901
Patients will take study medication daily, with dosage based on their assigned cohort and regimen.

Outcome Measures

Primary Outcome Measures

  1. Maximum tolerated dose [Approximately 1 year]

    Identify the maximum tolerated dose (or maximum tested dose if no maximum tolerated dose is identified) of SL-901 to be utilized.

  2. Identify an appropriate dosing regimen for further investigation of SL-901 [Approximately 1 year]

    Identify if the QD or BID dosing regimen will be utilized

  3. Characterize the pharmacokinetics (PK) profile of SL-901 [Approximately 1 year]

    Determine the maximum concentration of SL-901 in plasma

  4. Perform initial assessment of the safety profile of SL-901 [Approximately 1 year]

    The percentage of patients experiencing treatment-related and treatment-emergent adverse events

Secondary Outcome Measures

  1. Characterize the pharmacodynamics (PD) of SL-901 in blood [Approximately 1 year]

  2. Assess preliminary clinical activity of SL-901 [Approximately 1 year]

    Determine the objective response rate

  3. Characterize the pharmacodynamics (PD) of SL-901 in tissue [Approximately 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. 18 years old or older.

  2. Population by study stage:

  3. Part 1a: Patients with advanced, metastatic, and/or progressive solid tumors for whom there is no effective standard therapy available.

  4. Part 1b: Patients with histologically confirmed, advanced, metastatic, unresectable, and/or progressive solid tumors for whom there is no effective standard therapy available and their PI3K or DNA-PK pathway is deregulated or their tumor genetic profile has been shown to correlate with sensitivity to PI3K and/or DNA-PK inhibition based on clinical and preclinical experience. Specific criteria will be determined based on ongoing experiments and will be introduced in a future protocol amendment.

  5. Evaluable or measurable disease.

  6. Eastern Cooperative Oncology Group (ECOG) performance status ≤2.

  7. Able to take oral medications.

  8. If a woman of childbearing potential (WOCBP), the patient has a negative serum or urine pregnancy test within 1 week before Cycle 1, Day 1 (C1D1). Refer to Section 8.1.3 for further practical information about contraception.

  9. The patient (either male or female) agrees to use acceptable contraceptive methods for the duration of time in the study, and to continue to use acceptable contraceptive methods for 1 month after the last dose of SL-901. Refer to Section 8.1.3 for further practical information about contraception.

  10. Able to provide written informed consent.

  11. Willing to provide consent for biomarker analysis of existing paraffin-embedded tumor samples.

Exclusion Criteria:

  1. Received an investigational anticancer drug within 4 weeks of the first planned SL-901 dose.

  2. Received major surgery, radiotherapy, or immunotherapy within 4 weeks of C1D1. Localized palliative radiotherapy is permitted for symptom control.

  3. Received chemotherapy regimens with delayed toxicity within 4 weeks (6 weeks for prior nitrosourea or mitomycin C) of C1D1.

  4. Received chemotherapy regimens given continuously or on a weekly basis which have limited potential for delayed toxicity within 2 weeks of C1D1.

  5. Clinically significant, unresolved toxicity from previous anticancer therapy ≥Grade 2 (except alopecia), as determined by the Investigator using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0.

  6. Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs.

  7. Left ventricular ejection fraction <50%.

  8. Corrected QT interval (based on Fridericia's formula) >450 msec.

  9. Type 1 or 2 diabetes mellitus requiring medication. (In Part 1b, patients with type 2 diabetes mellitus controlled by medication, as indicated by a glycated hemoglobin of ≤7.5% are eligible.)

  10. Known active human immunodeficiency virus, hepatitis B, or hepatitis C infection.

  11. Ongoing systemic bacterial, fungal, or viral infection.

  12. History of interstitial pneumonitis.

  13. Absolute neutrophil count (ANC) 1.5×10⁹/L.

  14. Hemoglobin <10 g/dL.

  15. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5x the upper limit of normal (ULN).

  16. Known hypersensitivity or allergy to the active ingredient or excipients of SL-901.

  17. Breast-feeding females.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Royal Marsden Hospital Sutton Surrey United Kingdom SM2 5PT
2 Christie Hospital Manchester United Kingdom M20 4BX

Sponsors and Collaborators

  • Stemline Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Stemline Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT05382936
Other Study ID Numbers:
  • STML-901-0119
First Posted:
May 19, 2022
Last Update Posted:
May 19, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of May 19, 2022