STP938 for Solid Tumors

Recruiting at 7 trial locations

Overseen By Duc Tran

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Step Pharma, SAS

Must not be taking: Monoclonal antibodies

Disqualifiers: CNS metastases, Active malignancy, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called STP938 (Dencatistat) for individuals with solid tumors, which are advanced cancers not curable with current options. The first part of the trial determines the appropriate dose of STP938 when taken alone, while the second part assesses the treatment's safety at that dose. Suitable candidates for this trial include those with advanced cancer unresponsive to other treatments and specific tumor types that can be tested for biomarkers, which indicate the presence of cancer. Participants should have resolved most side effects from previous cancer treatments, except for hair loss. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had systemic cancer treatments or certain investigational therapies within 4 weeks before joining the trial.

Is there any evidence suggesting that STP938 is likely to be safe for humans?

Research shows that STP938, also known as dencatistat, is being tested for safety and tolerance in people with advanced solid tumors. Early studies examine how individuals manage this new oral drug. STP938 is a promising treatment that blocks a specific protein in cancer cells, potentially stopping cancer growth.

As the trial is in its early stages, researchers are determining the optimal dose. They closely monitor for any side effects or reactions. Currently, there is no clear information on side effects or tolerance, as these studies are just beginning. However, reaching this stage indicates that STP938 has passed initial safety checks required for human trials. If earlier lab tests had found it unsafe, it would not be tested in people now. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

STP938 is unique because it is administered as an oral monotherapy, which can be more convenient and less invasive than traditional chemotherapy infusions for solid tumors. Unlike standard treatments that often involve complex regimens of multiple drugs, STP938 focuses on a single active ingredient, which might reduce side effects and simplify treatment. Researchers are excited about STP938 because it offers a potential new approach to treating solid tumors, with the possibility of being effective at different dose levels, providing more options for tailoring treatment to individual patient needs.

What evidence suggests that STP938 might be an effective treatment for solid tumors?

Research has shown that STP938, the investigational treatment in this trial, could be a promising option for solid tumors by blocking a key enzyme necessary for cancer cell growth. Earlier studies with drugs similar to STP938 have significantly slowed or stopped tumor growth, meeting the National Cancer Institute's standards for effectiveness. Although human studies provide limited information, the drug's mechanism suggests it could help slow or stop tumor progression. This trial includes a Phase 1a dose escalation arm to determine the optimal dose for safety and effectiveness, followed by a Phase 1b safety expansion arm for further evaluation. ^{1 2 3 4 6}

Who Is on the Research Team?

Maureen Higgins

Principal Investigator

Step Pharma

Are You a Good Fit for This Trial?

This trial is for adults (18+) with advanced solid tumors that can't be cured by existing treatments. Participants must have a confirmed diagnosis, available tumor tissue for testing, measurable disease, and an ECOG performance status of ≤2. They should expect to live more than 3 months and have good organ function.

Inclusion Criteria

Life expectancy > 3 months as assessed by the Investigator

I can do most of my daily activities on my own.

My cancer can be measured by scans.

Exclusion Criteria

I have had cancer within the last 2 years.

I have an active hepatitis B or C infection.

I have active brain metastases or spinal cord issues related to cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1a: Dose Escalation

Dose escalation of STP938 as a monotherapy with up to 5 dose levels

9 days

Multiple visits for dose escalation and monitoring

Phase 1b: Safety Expansion

Safety expansion cohort of STP938 as a monotherapy at the RP2D

6 months

Regular visits for safety and efficacy assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• STP938

Trial Overview The study tests STP938 in two phases: Phase 1a explores increasing doses to find the maximum tolerated dose as a single agent; Phase 1b examines the safety profile of STP938 at this established dose when given alone.

How Is the Trial Designed?

Group I: Phase 1b (Part 2, Safety Expansion) Experimental Treatment 1 Intervention

Further evaluation of STP938 administered as oral monotherapy at the RP2D

Group II: Phase 1a (Part 1, Dose Escalation) Experimental Treatment 1 Intervention

Up to 5 dose levels with STP938 administered as oral monotherapy

Who Is Running the Clinical Trial?

Step Pharma, SAS

Lead Sponsor

Trials

3

Recruited

270+

Citations

1. step-ph.com step-ph.com/step-pharma-announces-first-patient-dosed-in-a-phase-1-trial-of-dencatistat-for-patients-with-solid-tumours/

Step Pharma announces first patient dosed in a phase 1 ... The first patient has been dosed at Next Oncology, San Antonio, TX USA, with its lead asset dencatistat (STP938) in a clinical trial for patients with solid ...

2. step-ph.com step-ph.com/step-pharma-announces-us-fda-clearance-for-a-phase-i-clinical-trial-in-solid-tumours-with-dencatistat-stp938/

+ Dencatistat The open label trial will evaluate the safety, tolerability and pharmacokinetics of dencatistat in adults living with advanced solid tumours.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0006497118704047

STP938, a Novel, Potent and Selective Inhibitor of CTP ... In all cases, in a dose-dependent manner, CTPS1 inhibitors reduced or ablated tumor growth meeting NCI criteria for efficacy. Conclusions: Our ...

4. synapse.patsnap.com synapse.patsnap.com/drug/0f7db994759e4304a7e53c7e71a67b59

Dencatistat - Drug Targets, Indications, Patents The Company's lead product STP938 has received both IND and CTA clearance to proceed into first in human trials in the US and UK for the treatment of T cell and ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05463263

NCT05463263 | A Phase 1/2 Study of STP938 for Adult ... The main outcome of the first part of the study is to see if STP938 can be given safely to patients with lymphoma, and to work out the best dose of STP938. The ...

6. sygnaturediscovery.com sygnaturediscovery.com/news-and-events/blog/lymphoma-treatment-enters-clinical-phase/

Novel Lymphoma Treatment Enters Clinical Phase Candidate STP938 entered the clinic in 2022 for treatment of relapsed/refractory B or T cell lymphoma patients – people with very few treatment options.