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Advanced Solid TumorPhase 1NCT05382936

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

A Phase 1 study testing SL-901 in people with Advanced Solid Tumor, run by Stemline Therapeutics, Inc. at 2 sites in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Study STML-901-0119 was a dose-escalation study evaluating multiple doses and schedules of orally administered SL-901 in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
SL-901
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesUnited Kingdom
Study dates
19 Mar 2021to 5 May 2023
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years old or older.
  • Population by study stage:
  • Part 1a: Patients with advanced, metastatic, and/or progressive solid tumors for whom there is no effective standard therapy available.
  • 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.
  • Evaluable or measurable disease.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
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  • Able to take oral medications.
  • 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.
  • 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.
  • Able to provide written informed consent.
  • Willing to provide consent for biomarker analysis of existing paraffin-embedded tumor samples.

Who cannot join

  • Received an investigational anticancer drug within 4 weeks of the first planned SL-901 dose.
  • Received major surgery, radiotherapy, or immunotherapy within 4 weeks of C1D1. Localized palliative radiotherapy is permitted for symptom control.
  • Received chemotherapy regimens with delayed toxicity within 4 weeks (6 weeks for prior nitrosourea or mitomycin C) of C1D1.
  • Received chemotherapy regimens given continuously or on a weekly basis which have limited potential for delayed toxicity within 2 weeks of C1D1.
  • 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.
  • Presence of active gastrointestinal disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs.
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  • Left ventricular ejection fraction <50%.
  • Corrected QT interval (based on Fridericia's formula) >450 msec.
  • 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.)
  • Known active human immunodeficiency virus, hepatitis B, or hepatitis C infection.
  • Ongoing systemic bacterial, fungal, or viral infection.
  • History of interstitial pneumonitis.
  • Absolute neutrophil count (ANC) 1.5×10⁹/L.
  • Hemoglobin <10 g/dL.
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5x the upper limit of normal (ULN).
  • Known hypersensitivity or allergy to the active ingredient or excipients of SL-901.
  • Breast-feeding females.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • Christie Hospital

    Manchester, M20 4BX

  • Royal Marsden Hospital

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

About this study

Official title: A Phase 1, Open-label, Dose-escalation Study of the PI3K Inhibitor SL-901 in Patients With Advanced Solid Tumors

Study STML-901-0119 was a dose-escalation study evaluating multiple doses and schedules of orally administered SL-901 in patients with advanced solid tumors.

Read the detailed description

Study STML-901-0119 was a multi-center, open-label, dose-escalation, and regimen-finding study aimed to investigate the safety, pharmacokinetics (PK), and pharmacodynamics of SL-901 in patients with advanced solid tumors. This study initially included two parts: Part 1a, which used a 3+3 dose-escalation design to determine the maximum tolerated dose and an appropriate dosing regimen of SL-901 when administered on both once-daily (QD) and twice-daily (BID) schedules; Part 1b, which was intended to evaluate the clinical activity of SL-901 at the selected dose in patients with advanced solid tumors with specific genetic alterations.

The study was stopped after careful consideration of the landscape of similar drugs and evolving standard of care. As a result, Part 1b was not initiated. In Part 1a, eligible patients were enrolled to receive SL-901 orally on a 28-day cycle. Study enrollment was conducted in 2 centers in the United Kingdom, and patients were assigned to either the QD or BID dosing regimen based on their cohort assignment.

Being tested
SL-901

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SL-901Drug

    Patients took study medication daily, with dosage based on their assigned cohort and regimen.

Study groups in NCT05382936
Study groupRoleWhat they receive
QD RegimenExperimentalPatients in the QD regimen took study medication once daily.
Receives: Drug: SL-901
BID RegimenExperimentalPatients in the BID regimen took study medication twice daily.
Receives: Drug: SL-901

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To Identify the MTD, Appropriate Dosing Regimen, PK Profile, and Perform Initial Assessment of the Safety Profile of SL-901

    • Safety endpoints include identification of DLTs; rate of TEAEs and SAEs; identification of abnormalities in physical examination, vital signs, clinical laboratory evaluations, and ECG findings.
    • PK endpoints include assessment of SL-901 plasma concentration over time; assessment of any changes in the PK properties of SL-901 between initial administration and steady-state and between cycles of treatment; explore the correlation between PK parameters and toxicity.

    Measured: Approximately 2 years

Secondary outcomes (2)

  1. Assess Preliminary Clinical Activity of SL-901 - Best Overall Response

    Clinical activity endpoints include the rate of objective response, rate of CR, DOR, PFS, and OS.

    Measured: Approximately 2 years

  2. Assess Preliminary Clinical Activity of SL-901 - PFS

    Progression-free Survival - Investigator's Assessment

    Measured: Approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2022
  2. Study start19 Mar 2021
  3. Primary completion5 May 2023
  4. Study completion5 May 2023

Why it stopped: The study was stopped after careful consideration of the landscape of similar drugs and evolving standard of care.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Patients were assigned to the QD or BID regimen based on cohort assignment.
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05382936
Sponsor's protocol ID
STML-901-0119
Status last verified
Nov 2024
First submitted
21 Oct 2021
Last updated
9 Jan 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ahn C. An evaluation of phase I cancer clinical trial designs. Stat Med. 1998 Jul 30;17(14):1537-49. doi: 10.1002/(sici)1097-0258(19980730)17:143.0.co;2-f.

    PubMed 9699228

  • Courtney KD, Corcoran RB, Engelman JA. The PI3K pathway as drug target in human cancer. J Clin Oncol. 2010 Feb 20;28(6):1075-83. doi: 10.1200/JCO.2009.25.3641. Epub 2010 Jan 19.

    PubMed 20085938

  • Gatsonis C, Greenhouse JB. Bayesian methods for phase I clinical trials. Stat Med. 1992 Jul;11(10):1377-89. doi: 10.1002/sim.4780111011.

    PubMed 1518998

  • Greenwell IB, Ip A, Cohen JB. PI3K Inhibitors: Understanding Toxicity Mechanisms and Management. Oncology (Williston Park). 2017 Nov 15;31(11):821-8.

    PubMed 29179250

  • Krause G, Hassenruck F, Hallek M. Copanlisib for treatment of B-cell malignancies: the development of a PI3K inhibitor with considerable differences to idelalisib. Drug Des Devel Ther. 2018 Aug 21;12:2577-2590. doi: 10.2147/DDDT.S142406. eCollection 2018.

    PubMed 30174412

  • Liu P, Cheng H, Roberts TM, Zhao JJ. Targeting the phosphoinositide 3-kinase pathway in cancer. Nat Rev Drug Discov. 2009 Aug;8(8):627-44. doi: 10.1038/nrd2926.

    PubMed 19644473

  • Storer BE. Design and analysis of phase I clinical trials. Biometrics. 1989 Sep;45(3):925-37.

    PubMed 2790129

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SL-901 in people with Advanced Solid Tumor, run by Stemline Therapeutics, Inc. at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To Identify the MTD, Appropriate Dosing Regimen, PK Profile, and Perform Initial Assessment of the Safety Profile of SL-901 (time frame: Approximately 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05382936, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.

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