A Phase 1 interventional study of STP938 in Solid Tumor, sponsored by Step Pharma, SAS. Recruiting at 7 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Step Pharma, SAS · Phase 1, Interventional, and Treatment
The Phase 1a part of the study is a dose escalation of STP938 as a monotherapy.
The Phase 1b part of the study is a safety expansion cohort of STP938 as a monotherapy.
Step Pharma, SAS is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Main Exclusion Criteria:
Up to 5 dose levels with STP938 administered as oral monotherapy
Drug: STP938
Further evaluation of STP938 administered as oral monotherapy at the RP2D
Drug: STP938
Small molecule
Safety and Tolerability
Incidence of dose limiting toxicities (DLTs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs)
Time frame: Through study completion, an average of 6 months
Area under the curve (AUC) of STP938
Pharmacokinetic parameter from plasma STP938 levels
Time frame: 9 days
Maximum plasma concentration (Cmax)
Pharmacokinetic parameter from plasma STP938 levels
Time frame: 9 Days
Time to reach maximum concentration (TMax)
Pharmacokinetic parameter from plasma STP938 levels
Time frame: 9 Days
Evaluation of preliminary clinical activity of STP938
Evaluation of ORR using standard response criteria
Time frame: Through study completion, an average of 6 months
Evaluation of best overall response of STP938
Evaluation of best overall response (Complete response \[CR\], Partial response \[PR\], Stable disease \[SD\], Progression of disease \[PD\], Not evaluable, Not applicable) using standard response criteria
Time frame: Through study completion, an average of 6 months
Evaluation of Duration of Response
Duration of response (DoR) is defined as the time, in days, from the date measurement criteria that are first met for CR or PR (whichever is first recorded) to the first date that relapse, progressive disease or death, whichever occurs first
Time frame: Through study completion, an average of 6 months
Evaluation of Progression Free Survival
Progression-free survival (PFS) is defined as the time from first STP938 dose to the date of disease progression or death, whichever occurs first
Time frame: Through study completion, an average of 6 months
Change in serum CA125 (ovarian cancer only)
Evaluation of CA125 using standard response criteria
Time frame: Through study completion, an average of 6 months
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Step Pharma, SAS