Study of STP938 in Advanced Solid Tumours

Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06297525
• Other study ID #: STP938-201
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: September 2024
• Est. completion date: May 2027

Study information

• Verified date: March 2024
• Source: Step Pharma, SAS
• Contact: Maureen Higgins
• Phone: +33 1 86 26 43 56
• Email: STP938-201[@]step-ph.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: May 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• STP938
Small molecule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Step Pharma, SAS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability	Incidence of dose limiting toxicities (DLTs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs)	Through study completion, an average of 6 months
Secondary	Area under the curve (AUC) of STP938	Pharmacokinetic parameter from plasma STP938 levels	9 days
Secondary	Maximum plasma concentration (Cmax)	Pharmacokinetic parameter from plasma STP938 levels	9 Days
Secondary	Time to reach maximum concentration (TMax)	Pharmacokinetic parameter from plasma STP938 levels	9 Days
Secondary	Evaluation of preliminary clinical activity of STP938	Evaluation of ORR using standard response criteria	Through study completion, an average of 6 months
Secondary	Evaluation of best overall response of STP938	Evaluation of best overall response (Complete response [CR], Partial response [PR], Stable disease [SD], Progression of disease [PD], Not evaluable, Not applicable) using standard response criteria	Through study completion, an average of 6 months
Secondary	Evaluation of Duration of Response	Duration of response (DoR) is defined as the time, in days, from the date measurement criteria that are first met for CR or PR (whichever is first recorded) to the first date that relapse, progressive disease or death, whichever occurs first	Through study completion, an average of 6 months
Secondary	Evaluation of Progression Free Survival	Progression-free survival (PFS) is defined as the time from first STP938 dose to the date of disease progression or death, whichever occurs first	Through study completion, an average of 6 months
Secondary	Change in serum CA125 (ovarian cancer only)	Evaluation of CA125 using standard response criteria	Through study completion, an average of 6 months