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New treatment option for Lymphoma, B-Cell
Official title A Phase 1/2 Study of STP938 (Dencatistat) for Adult Subjects With Relapsed/Refractory B-Cell and T-Cell Lymphomas
ClinicalTrials.gov ID: NCT05463263
What this study is testing
What is STP938?
STP938 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for lymphoma, b-cell.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The Phase 1 part of the study is a dose escalation of STP938 as monotherapy. The Phase 2 part of the study is cohort expansion of STP938 as a monotherapy in 5 different B and T cell lymphomas.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Main
- Signed and dated informed consent, and able to comply with the study procedures and any locally required authorization.
- Male or female aged ≥ 18 years.
- Relapsed/refractory patients with histologically confirmed diagnosis of B cell or T cell lymphoma
- Must have received at least 2 prior systemic therapies and have no treatment options known to provide clinical benefit
You likely can't join if
- Pregnant or breastfeeding females and women of child bearing potential or males unwilling to comply with contraception requirements.
- Known carcinomatous meningitis or central nervous system (CNS) involvement with lymphoma.
- Active malignancy within 2 years of study enrollment
- Prior radiation or surgical resection of their lymphoma without additional sites of measurable disease outside of the radiation field or people who...
- Systemic cancer treatments, monoclonal antibody-directed therapies, other investigational agents within 4 weeks before enrollment, or \<5 half-lives...
- Uncontrolled intercurrent illness.
See the full eligibility criteria
- Main
- Signed and dated informed consent, and able to comply with the study procedures and any locally required authorization.
- Male or female aged ≥ 18 years.
- Relapsed/refractory patients with histologically confirmed diagnosis of B cell or T cell lymphoma
- Must have received at least 2 prior systemic therapies and have no treatment options known to provide clinical benefit
- Must have measurable disease per Lugano lymphoma classification except for cutaneous T-cell lymphoma (CTCL) which is measured via International Society for Cutaneous Lymphomas (ISCL)/ European Organization of Research...
- 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
- Pregnant or breastfeeding females and women of child bearing potential or males unwilling to comply with contraception requirements.
- Known carcinomatous meningitis or central nervous system (CNS) involvement with lymphoma.
- Active malignancy within 2 years of study enrollment
- Prior radiation or surgical resection of their lymphoma without additional sites of measurable disease outside of the radiation field or people who have received prior radiation or surgical resection of their lymphoma...
- 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...
- Uncontrolled intercurrent illness.
- Immunocompromised people 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.
- people who have received a live vaccine within 30 days prior to study enrollment or whilst participating in the study.
- people 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).
- people who received a severe acute respiratory syndrome coronavirus 2 vaccine ≤3 weeks prior to study drug dosing.
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- Sarasota, Florida, United States
- New York, New York, United States
- Paris, Paris, France
- Lyon, France
- Marseille, France
- Nantes, France
- Villejuif, France
- Leicester, United Kingdom
- London, United Kingdom
- Manchester, United Kingdom
- Nottingham, United Kingdom
- Oxford, United Kingdom
- Plymouth, United Kingdom
- Sutton, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States; Sarasota, Florida, United States; New York, New York, United States; Paris, Paris, France; Lyon, France; Marseille, France and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.