Study of STP938 in Advanced Solid Tumours

Trial Title: Study of STP938 in Advanced Solid Tumours

NCT ID: NCT06297525

Condition: Solid Tumor

Conditions: Official terms:
Neoplasms

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: Non-Randomized

Intervention model: Sequential Assignment

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

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: STP938
Description: Small molecule
Arm group label: Phase 1a (Part 1, Dose Escalation)
Arm group label: Phase 1b (Part 2, Safety Expansion)

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.

Criteria for 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).

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Mary Crowley Cancer Research Center

Address:
City: Dallas
Zip: 75251
Country: United States

Status: Recruiting

Facility:
Name: Next Oncology

Address:
City: San Antonio
Zip: 78292
Country: United States

Status: Recruiting

Start date: August 2, 2024

Completion date: May 2027

Lead sponsor:
Agency: Step Pharma, SAS
Agency class: Industry

Source: Step Pharma, SAS

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06297525