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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1a (Part 1, Dose Escalation) | Experimental | Up to 5 dose levels with STP938 administered as oral monotherapy |
|
| Phase 1b (Part 2, Safety Expansion) | Experimental | Further evaluation of STP938 administered as oral monotherapy at the RP2D |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STP938 | Drug | Small molecule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability | Incidence of dose limiting toxicities (DLTs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs) | Through study completion, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the curve (AUC) of STP938 | Pharmacokinetic parameter from plasma STP938 levels | 9 days |
| Maximum plasma concentration (Cmax) | Pharmacokinetic parameter from plasma STP938 levels |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maureen Higgins | Contact | +33 1 86 26 43 56 | STP938-201@step-ph.com | |
| Duc Tran | Contact | +33 1 86 26 43 56 | STP938-201@step-ph.com |
| Name | Affiliation | Role |
|---|---|---|
| Maureen Higgins | Step Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Hematology Oncology, LLC | Recruiting | St. Petersburg | Florida | 33709 | United States | |
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Patients will be assigned to a dose level of STP938 (Phase 1a) or an expansion cohort (Phase 1b) at the time of their enrollment.
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| 9 Days |
| Time to reach maximum concentration (TMax) | Pharmacokinetic parameter from plasma STP938 levels | 9 Days |
| Evaluation of preliminary clinical activity of STP938 | Evaluation of ORR using standard response criteria | 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 | 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 | 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 | Through study completion, an average of 6 months |
| Change in serum CA125 (ovarian cancer only) | Evaluation of CA125 using standard response criteria | Through study completion, an average of 6 months |
| Mary Crowley Cancer Research Center |
| Recruiting |
| Dallas |
| Texas |
| 75251 |
| United States |
| Next Oncology | Recruiting | San Antonio | Texas | 78292 | United States |
| Institut Gustave Roussy | Recruiting | Villejuif | Paris | 94805 | France |
| The Beatson Institute for Cancer Research | Recruiting | Glasgow | Glasgow | G12 8QQ | United Kingdom |
| University College London | Recruiting | London | United Kingdom |
| The Christie | Recruiting | Manchester | M20 4BX | United Kingdom |