18 and older, any sex, with Advanced Solid Tumor. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
To Identify the MTD, Appropriate Dosing Regimen, PK Profile, and Perform Initial Assessment of the Safety Profile of SL-901Primary· Approximately 2 years
* 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.
Any TEAE
Group
Value
95% CI
Cohort 1: SL-901 20 mg
3
Cohort 2: SL-901 40 mg
7
Cohort 3: SL-901 60 mg
4
Cohort 4: SL-901 80 mg
5
Any SAE
Group
Value
95% CI
Cohort 1: SL-901 20 mg
1
Cohort 2: SL-901 40 mg
3
Cohort 3: SL-901 60 mg
6
Cohort 4: SL-901 80 mg
0
Assess Preliminary Clinical Activity of SL-901 - Best Overall ResponseSecondary· Approximately 2 years
Clinical activity endpoints include the rate of objective response, rate of CR, DOR, PFS, and OS.
Best Overall Response - Missing
Group
Value
95% CI
Cohort 1: SL-901 20 mg
0
Cohort 2: SL-901 40 mg
1
Cohort 3: SL-901 60 mg
1
Cohort 4: SL-901 80 mg
0
Best Overall Response - Stable Disease
Group
Value
95% CI
Cohort 1: SL-901 20 mg
0
Cohort 2: SL-901 40 mg
2
Cohort 3: SL-901 60 mg
1
Cohort 4: SL-901 80 mg
2
Best Overall Response - Progressive Disease
Group
Value
95% CI
Cohort 1: SL-901 20 mg
3
Cohort 2: SL-901 40 mg
4
Cohort 3: SL-901 60 mg
1
Cohort 4: SL-901 80 mg
4
Best Overall Response - Not Evaluable
Group
Value
95% CI
Cohort 1: SL-901 20 mg
0
Cohort 2: SL-901 40 mg
0
Cohort 3: SL-901 60 mg
1
Cohort 4: SL-901 80 mg
0
Assess Preliminary Clinical Activity of SL-901 - PFSSecondary· Approximately 2 years
Time frame: All serious and non-SAEs recorded in the study's clinical database from the day of first exposure to SL-901 through 30 days after the last dose of SL-901 (approximately 2 years)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort 1: SL-901 20 mg
Serious: 1/3 (33%)
Deaths: 0/3
Cohort 2: SL-901 40 mg
Serious: 3/7 (43%)
Deaths: 1/7
Cohort 3: SL-901 60 mg
Serious: 3/4 (75%)
Deaths: 2/4
Cohort 4: SL-901 80 mg
Serious: 0/6 (0%)
Deaths: 2/6
Serious adverse events (9 terms)
Reaction
System
Cohort 1: SL-901 20 mg
Cohort 2: SL-901 40 mg
Cohort 3: SL-901 60 mg
Cohort 4: SL-901 80 mg
Intestinal obstruction
Gastrointestinal disorders
—
—
—
—
Device related infection
Infections and infestations
—
—
—
—
Infective exacerbation of chronic obstructive airways disease
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Stemline Therapeutics, Inc.
Last refreshed: 9 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05382936.