RecruitingPhase 1NCT06297525

Study of STP938 in Advanced Solid Tumours

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

Sponsor

Step Pharma, SAS

Enrollment

70 participants

Start Date

Aug 2, 2024

Study Type

INTERVENTIONAL

Conditions

Solid Tumor

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria10

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.

Exclusion Criteria9

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).