Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
70 participants
INTERVENTIONAL
2024-08-02
2027-05-31
Brief Summary
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The Phase 1b part of the study is a safety expansion cohort of STP938 as a monotherapy.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1a (Part 1, Dose Escalation)
Up to 5 dose levels with STP938 administered as oral monotherapy
STP938
Small molecule
Phase 1b (Part 2, Safety Expansion)
Further evaluation of STP938 administered as oral monotherapy at the RP2D
STP938
Small molecule
Interventions
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STP938
Small molecule
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Step Pharma, SAS
INDUSTRY
Responsible Party
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Principal Investigators
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Maureen Higgins
Role: STUDY_DIRECTOR
Step Pharma
Locations
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Comprehensive Hematology Oncology, LLC
St. Petersburg, Florida, United States
Mary Crowley Cancer Research Center
Dallas, Texas, United States
Next Oncology
San Antonio, Texas, United States
Institut Gustave Roussy
Villejuif, Paris, France
The Beatson Institute for Cancer Research
Glasgow, , United Kingdom
University College London
London, , United Kingdom
The Christie
Manchester, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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STP938-201
Identifier Type: -
Identifier Source: org_study_id
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