Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventionalPhase 1

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

NCT ID: NCT06297525Sponsor: Step Pharma, SASLast updated: 2026-06-16

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.

Arms & interventions

  • DrugSTP938

    Small molecule

Outcome measures

Primary

  • Safety and Tolerability

    Incidence of dose limiting toxicities (DLTs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs)

    Time frame: Through study completion, an average of 6 months

Secondary

  • Area under the curve (AUC) of STP938

    Time frame: 9 days

  • Maximum plasma concentration (Cmax)

    Time frame: 9 Days

  • Time to reach maximum concentration (TMax)

    Time frame: 9 Days

  • Evaluation of preliminary clinical activity of STP938

    Time frame: Through study completion, an average of 6 months

  • Evaluation of best overall response of STP938

    Time frame: Through study completion, an average of 6 months

  • Evaluation of Duration of Response

    Time frame: Through study completion, an average of 6 months

  • Evaluation of Progression Free Survival

    Time frame: Through study completion, an average of 6 months

  • Change in serum CA125 (ovarian cancer only)

    Time frame: Through study completion, an average of 6 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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).

Study locations (3)

Comprehensive Hematology Oncology, LLC

St. Petersburg, Florida, 33709

Recruiting

Mary Crowley Cancer Research Center

Dallas, Texas, 75251

Recruiting

Next Oncology

San Antonio, Texas, 78292

Recruiting