Solid Tumor
Conditions
Brief summary
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.
Interventions
DRUGSTP938
Small molecule
Sponsors
Step Pharma, SAS
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be assigned to a dose level of STP938 (Phase 1a) or an expansion cohort (Phase 1b) at the time of their enrollment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Signed and dated informed consent, and able to comply with the study procedures and any locally required authorization. * Male or female aged ≥ 18 years. * Advanced disease not curable by available therapies and requires systemic therapy. * Histologically confirmed diagnosis of eligible cancer type. * Must have tumor tissue available for biomarker testing. * Measurable disease (Part 1) and measurable disease per RECIST (Part2) * Eastern Cooperative Oncology Group (ECOG) performance status ≤2. * Life expectancy \> 3 months as assessed by the Investigator. * Adequate organ function (bone marrow, hepatic, renal function and coagulation). * All toxicities (except alopecia) from prior cancer treatments or procedures must have resolved to ≤Grade 1 or returned to baseline levels prior to enrollment. Main
Exclusion criteria
* Pregnant or breastfeeding females and women of childbearing potential or males unwilling to comply with contraception requirements. * Known active or symptomatic CNS metastases, carcinomatous meningitis, leptomeningeal disease or a history of spinal cord compression * Active malignancy within 2 years of study enrollment * Prior radiation within 2 weeks of start of therapy. * Systemic cancer treatments, monoclonal antibody-directed therapies, other investigational agents within 4 weeks before enrollment, or \<5 half-lives since completion of previous investigational therapy, whichever is shorter. * Uncontrolled intercurrent illness. * Immunocompromised subjects with increased risk of opportunistic infections or history of opportunistic infection in the last 12 months. * Known active or chronic hepatitis B or active hepatitis C virus (HCV) infection. * Subjects with corrected QT interval \>470 msec based on averaged triplicate electrocardiogram (ECG) readings at the Screening Visit using the QT interval corrected for heart rate using Fridericia's method (QTcF).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability | Through study completion, an average of 6 months | Incidence of dose limiting toxicities (DLTs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve (AUC) of STP938 | 9 days | Pharmacokinetic parameter from plasma STP938 levels |
| Maximum plasma concentration (Cmax) | 9 Days | Pharmacokinetic parameter from plasma STP938 levels |
| Time to reach maximum concentration (TMax) | 9 Days | Pharmacokinetic parameter from plasma STP938 levels |
| Evaluation of preliminary clinical activity of STP938 | Through study completion, an average of 6 months | Evaluation of ORR using standard response criteria |
| Evaluation of best overall response of STP938 | Through study completion, an average of 6 months | 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 |
| Evaluation of Duration of Response | Through study completion, an average of 6 months | 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 |
| Evaluation of Progression Free Survival | Through study completion, an average of 6 months | Progression-free survival (PFS) is defined as the time from first STP938 dose to the date of disease progression or death, whichever occurs first |
| Change in serum CA125 (ovarian cancer only) | Through study completion, an average of 6 months | Evaluation of CA125 using standard response criteria |
Countries
France, United Kingdom, United States
Contacts
CONTACTMaureen Higgins
CONTACTDuc Tran
STUDY_DIRECTORMaureen Higgins
Step Pharma
Outcome results
None listed