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
- MEN1703 (drug), Glofitamab (drug)
- How long the study runs
- Study runs about 24 months (dates as stated)
- About the drug or intervention
- MEN1703 — drug: MEN1703 (Dapolsertib hydrochloride) is a potent dual inhibitor of proviral integration site for Moloney murine leukemia virus (PIM) kinases and Fms-like tyrosine kinase 3 (FLT3). · Glofitamab — drug: Glofitamab is a bispecific monoclonal antibody that binds bivalently to CD20 expressed on the surface of B-cells and monovalently to CD3 in the T-cell receptor complex expressed on the surface of T-cells.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 178
- Started
- 2024-12-05
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for non-hodgkin lymphoma, b-cell
- • Phase2 - 178 participants
- • The goal of the study is to assess the safety and anti-lymphoma activity of MEN1703 (Dapolsertib hydrochloride) when given as a single-agent or combined with glofitamab to patients with relapsed/refractory (R/R) aggressive B-cell non-Hodgkin lymphoma
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with non-hodgkin lymphoma, b-cell
Where?
- • Glasgow - Beatson West of Scotland Cancer Centre
- • Manchester - The Christie NHS Foundation Trust
- • Plymouth - Plymouth Hospitals NHS Trust
- • Sutton - The Royal Marsden Hospital
- • +1 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The goal of the study is to assess the safety and anti-lymphoma activity of MEN1703 (Dapolsertib hydrochloride) when given as a single-agent or combined with glofitamab to patients with relapsed/refractory (R/R) aggressive B-cell non-Hodgkin lymphoma. The study will be open to groups at the same time: * Group 1 - patients who have not had anti-CD3xCD20 bispecific antibody therapy but who have had at least 2 prior lines of systemic treatment for aggressive B-cell non-Hodgkin lymphoma * Group 2 - patients who have exhausted all standard treatment options including at least 2 prior lines of systemic treatment for aggressive B-cell non-Hodgkin lymphoma Group 1 patients will be treated for a maximum of 12 cycles. One cycle is 21 days. Group 2 with be treated until the disease progresses, therefore treatment duration is dependent on the number of treatment cycles a participant receives prior to progression.
More detail
The study consists of 3 parts, to investigate MEN1703 (Dapolsertib hydrochloride) in combination with glofitamab in patients who are naïve to treatment with an anti-CD3xCD20 bispecific antibody (group 1) or MEN1703 alone in patients who have exhausted all standard treatment options (group 2). Part 1 (safety run-in) and Part 2 (enrichment): patients who are naïve to treatment with an anti-CD3xCD20 bispecific antibody (group 1) will receive either 150 mg or 125 mg of MEN1703 along with glofitamab. Patients who have exhausted all standard treatment options (group 2) will receive 125 mg of MEN1703 as a single-agent. Part 3 (optional randomized comparison): Patients who are naïve to treatment with an anti-CD3xCD20 bispecific antibody therapy will be randomized to receive either MEN1703 (Dapolsertib hydrochloride) at a dose selected from part 2 in combination with glofitamab or glofitamab alone.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
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
Biomarkers mentioned
What the study is looking for
- ✓Age ≥18 years old
- ✓Documented histological confirmation of aggressive B-cell non-Hodgkin lymphoma including DLBCL NOS and transformed...
- ✓At least 1 measurable site of disease based on computed tomography (CT) or positron emission tomography (PET)-CT...
- ✓Availability of lymph node tissue at Screening (or archival sample) (part 2 participants only)
- ✓Life expectancy of ≥12 weeks.
Who cannot take part
- ✗Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma at screening.
- ✗Concurrent participation in another therapeutic clinical study.
- ✗Prior treatment with a PIM inhibitor.
- ✗Group 1 only: Any prior therapy with a bispecific antibody targeting CD3 and CD20.
- ✗Known risk of allergy to the study drugs, MEN1703 (group 1 and 2) or glofitamab (group 1) or their excipients
See the full criteria
Where Is This Study? (5 UK sites)
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom
Plymouth Hospitals NHS Trust
Plymouth, United Kingdom
The Royal Marsden Hospital
Sutton, United Kingdom
St George's Hospital
Tooting, United Kingdom
How to Get in Touch
Head of Clinical Operations
Sponsor contactCONTACT
