Solid TumorPhase 1NCT06297525
Study of STP938 (Dencatistat) in Advanced Solid Tumours
A Phase 1 study testing STP938 in people with Solid Tumor, run by Step Pharma, SAS at 7 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- STP938
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 2 Aug 2024to May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Trial locations and contacts
7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 3 countries
United States3 sites, 3 recruiting
- Recruiting
Mary Crowley Cancer Research Center
Dallas, Texas, 75251
- Recruiting
Next Oncology
San Antonio, Texas, 78292
- Recruiting
Comprehensive Hematology Oncology, LLC
St. Petersburg, Florida, 33709
United Kingdom3 sites, 3 recruiting
- Recruiting
The Beatson Institute for Cancer Research
Glasgow, Glasgow, G12 8QQ
- Recruiting
University College London
London
- Recruiting
The Christie
Manchester, M20 4BX
France1 site, 1 recruiting
- Recruiting
Institut Gustave Roussy
Villejuif, Paris, 94805
About this study
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
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.
- Conditions
- Solid Tumor
- Being tested
- STP938
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STP938Drug
Small molecule
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a (Part 1, Dose Escalation) | Experimental | Up to 5 dose levels with STP938 administered as oral monotherapy Receives: Drug: STP938 |
| Phase 1b (Part 2, Safety Expansion) | Experimental | Further evaluation of STP938 administered as oral monotherapy at the RP2D Receives: Drug: STP938 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Incidence of dose limiting toxicities (DLTs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs)
Measured: Through study completion, an average of 6 months
Secondary outcomes (8)
Area under the curve (AUC) of STP938
Pharmacokinetic parameter from plasma STP938 levels
Measured: 9 days
Maximum plasma concentration (Cmax)
Pharmacokinetic parameter from plasma STP938 levels
Measured: 9 Days
Time to reach maximum concentration (TMax)
Pharmacokinetic parameter from plasma STP938 levels
Measured: 9 Days
Evaluation of preliminary clinical activity of STP938
Evaluation of ORR using standard response criteria
Measured: Through study completion, an average of 6 months
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
Measured: Through study completion, an average of 6 months
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
Measured: Through study completion, an average of 6 months
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
Measured: Through study completion, an average of 6 months
Change in serum CA125 (ovarian cancer only)
Evaluation of CA125 using standard response criteria
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2024
- Study start2 Aug 2024
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Step Pharma, SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maureen Higgins, Study director, Step Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06297525
- Sponsor's protocol ID
- STP938-201
- Status last verified
- Jun 2026
- First submitted
- 29 Feb 2024
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06297525
- Acronym / sponsor ID
- STP938-201
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Step Pharma, SASIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 7 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Phase 1a (Part 1, Dose Escalation) | Experimental | Drug: STP938Up to 5 dose levels with STP938 administered as oral monotherapy |
| Phase 1b (Part 2, Safety Expansion) | Experimental | Drug: STP938Further evaluation of STP938 administered as oral monotherapy at the RP2D |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STP938Small molecule | Drug | Phase 1a (Part 1, Dose Escalation), Phase 1b (Part 2, Safety Expansion) |
Primary outcome
Safety and Tolerability
Time frame: Through study completion, an average of 6 months
Incidence of dose limiting toxicities (DLTs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs)
8 secondary outcomes
Area under the curve (AUC) of STP938
Time frame: 9 days
Maximum plasma concentration (Cmax)
Time frame: 9 Days
Time to reach maximum concentration (TMax)
Time frame: 9 Days
Evaluation of preliminary clinical activity of STP938
Time frame: Through study completion, an average of 6 months
Evaluation of best overall response of STP938
Time frame: Through study completion, an average of 6 months
Evaluation of Duration of Response
Time frame: Through study completion, an average of 6 months
Evaluation of Progression Free Survival
Time frame: Through study completion, an average of 6 months
Change in serum CA125 (ovarian cancer only)
Time frame: Through study completion, an average of 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maureen Higgins study director
Step Pharma
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing STP938 in people with Solid Tumor, run by Step Pharma, SAS at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, United Kingdom, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maureen Higgins (+33 1 86 26 43 56, STP938-201@step-ph.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.