Informations générales (source: ClinicalTrials.gov)
An Open-Label, Phase 1 Study to Evaluate Safety, Tolerability and Pharmacokinetics of the CTPS1 Inhibitor STP938 in Adult Subjects With Advanced Solid Tumors, With a Safety Expansion in Advanced CTPS2 Null Ovarian Cancer
Interventional
Phase 1
Step Pharma, SAS (Voir sur ClinicalTrials)
août 2024
mai 2027
16 avril 2025
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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).