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Looking for participantsPhase1

Study of STP938 (Dencatistat) in Advanced Solid Tumours

Sponsor: Step Pharma, SAS

NCT ID: NCT06297525

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
STP938 (drug)
How long the study runs
Study runs about 33 months (dates as stated)
About the drug or intervention
STP938 — drug: Small molecule
Patient visit burden
Not specified by the sponsor

In plain English

This study is testing a new drug called STP938 (also known as dencatistat) in people with advanced solid tumours. These are cancers that cannot be cured by existing treatments and need body-wide (systemic) therapy. It is run by Step Pharma, SAS.

Who can take part

  • Adults aged 18 or over, male or female
  • Cancer that is advanced, cannot be cured by available treatments, and needs body-wide therapy
  • Diagnosis of an eligible cancer type confirmed by looking at tissue under a microscope
  • Tumour tissue available for laboratory testing
  • Measurable disease (tumours that can be measured)
  • Able to carry out daily activities with limited or some rest (Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less)
  • Expected to live more than 3 months, in the study doctor's view
  • Healthy enough bone marrow, liver, kidneys, and blood clotting
  • Side effects from earlier cancer treatment must have mostly gone away or returned to normal before joining (hair loss does not count)
  • Able to give informed consent and follow the study procedures

Who may not be able to

  • People who are pregnant or breastfeeding, or those able to have children (or men) who will not follow the contraception rules
  • Cancer that has spread to the brain or spinal fluid and is causing symptoms, or past spinal cord compression
  • Another cancer within the last 2 years
  • Radiotherapy within 2 weeks of starting the study treatment
  • Cancer drugs, antibody therapies, or experimental treatments within 4 weeks before joining (or less than 5 half-lives since an experimental drug, if sooner)
  • Another serious illness that is not under control
  • People with a weakened immune system or a history of certain infections in the last 12 months
  • Active or long-term hepatitis B, or active hepatitis C infection
  • A certain heart rhythm reading on a heart trace (electrocardiogram (ECG)) that is longer than the allowed limit

What taking part involves

  • • Not stated — ask the trial team

Time commitment: Visits, duration, and what taking part involves: not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
70
Started
2024-08-02
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for solid tumor
  • • Phase1 - 70 participants
  • • The Phase 1a part of the study is a dose escalation of STP938 as a monotherapy

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with solid tumor

Where?

  • • Glasgow - The Beatson Institute for Cancer Research
  • • London - University College London
  • • Manchester - The Christie

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Solid Tumor

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ authorization
  • ✓ systemic therapy
  • ✓ tumor tissue available for biomarker testing
  • ✓ resolved to ≤Grade 1 or returned to baseline levels

What the study is looking for

  • ✓Signed and dated agreement to take part, 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 treatment that goes through your whole body.
  • ✓confirmed by a biopsy diagnosis of eligible cancer type.
  • ✓Must have tumor tissue available for test result testing.

Who cannot take part

  • ✗Pregnant or breastfeeding females and women of childbearing potential or males unwilling to comply with...
  • ✗Known active or causing symptoms CNS metastases, carcinomatous meningitis, leptomeningeal disease or a history of spinal...
  • ✗Active cancer within 2 years of study enrollment
  • ✗Prior radiation within 2 weeks of start of therapy.
  • ✗Uncontrolled intercurrent illness.
See the full 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).

Where Is This Study? (3 UK sites)

The Beatson Institute for Cancer Research

Glasgow G12 8QQ, United Kingdom

Recruiting

University College London

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Rajinder Sidhu - Associate Director, Research Governance and Operations

uclh.jro-communications@nhs.net020 3447 9825

The Christie

Manchester M20 4BX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

How to Get in Touch

Maureen Higgins

Sponsor contact

CONTACT

+33 1 86 26 43 56 STP938-201@step-ph.com

Duc Tran

Sponsor contact

CONTACT

+33 1 86 26 43 56 STP938-201@step-ph.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-06