Clinical trial NCT06297525: Study of STP938 in Advanced Solid Tumours
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Step Pharma, SAS
Sponsor class: INDUSTRY
First posted: 2024-03-07
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Safety and Tolerability
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
measure: Area under the curve (AUC) of STP938
timeFrame: 9 days
measure: Maximum plasma concentration (Cmax)
timeFrame: 9 Days
measure: Time to reach maximum concentration (TMax)
timeFrame: 9 Days
measure: Evaluation of preliminary clinical activity of STP938
timeFrame: Through study completion, an average of 6 months
measure: Evaluation of best overall response of STP938
timeFrame: Through study completion, an average of 6 months
measure: Evaluation of Duration of Response
timeFrame: Through study completion, an average of 6 months
measure: Evaluation of Progression Free Survival
timeFrame: Through study completion, an average of 6 months
measure: Change in serum CA125 (ovarian cancer only)
timeFrame: Through study completion, an average of 6 months
Other outcomes:
Locations:
city: Saint Petersburg
country: United States
facility: Comprehensive Hematology Oncology, LLC
state: Florida
city: Dallas
country: United States
facility: Mary Crowley Cancer Research Center
state: Texas
city: San Antonio
country: United States
facility: Next Oncology
state: Texas
city: Villejuif
country: France
facility: Institut Gustave Roussy
state: Paris
city: Glasgow
country: United Kingdom
facility: The Beatson Institute for Cancer Research
city: London
country: United Kingdom
facility: University College London
city: Manchester
country: United Kingdom
facility: The Christie
Study officials:
affiliation: Step Pharma
name: Maureen Higgins
role: STUDY_DIRECTOR
References: