Clinical Trials in the UK / NCT06297525
Recruiting
Phase 1
Study of STP938 (Dencatistat) in Advanced Solid Tumours
NCT06297525 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Solid Tumor
Study 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
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 outcome measure(s)
- Safety and Tolerability — Through study completion, an average of 6 months
Incidence of dose limiting toxicities (DLTs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs)
Trial sites (7)
| Facility | City | Region | Status |
|---|---|---|---|
| Comprehensive Hematology Oncology, LLC | St. Petersburg | Florida | Recruiting |
| Mary Crowley Cancer Research Center | Dallas | Texas | Recruiting |
| Next Oncology | San Antonio | Texas | Recruiting |
| Institut Gustave Roussy | Villejuif | Paris | Recruiting |
| The Beatson Institute for Cancer Research | Glasgow | Glasgow | Recruiting |
| University College London | London | United Kingdom | Recruiting |
| The Christie | Manchester | United Kingdom | Recruiting |
More Step Pharma, SAS trials in the UK
Other trials for the same condition
Study of GS-4528 in Adults With Solid Tumors
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06297525 on ClinicalTrials.gov ↗ ← All trials in the UK