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An Open Label, Phase 2 Clinical Trial of MEN1703 as Monotherapy and in Combination With Glofitamab in Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Centre Hospitalier Le Mans
Le Mans, France
CHU de Lille - Hôpital Claude Huriez
Lille, France
CHU de Limoges - CHU Dupuytren
Limoges, France
Hospices Civils De Lyon - Hôpital Lyon Sud
Lyon, France
CHU Montpellier - Hôpital Saint Eloi
Montpellier, France
APHP - Hôpital Pitié-Salpêtrière
Paris, France
CHU de Bordeaux - Hôpital Haut-Lévêque
Pessac, France
Wojewódzki Szpital Specjalistyczny w Białej Podlaskiej
Biała Podlaska, Poland
IN-VIVO Bydgoszcz Sp. z o.o.
Bydgoszcz, Poland
Klinika Hematologii I Transplantologii Uck
Gdansk, Poland
Start Date
December 5, 2024
Primary Completion Date
December 1, 2026
Completion Date
December 1, 2026
Last Updated
September 29, 2025
178
ESTIMATED participants
MEN1703
DRUG
Glofitamab
DRUG
Lead Sponsor
Ryvu Therapeutics SA
Collaborators
NCT06318884
NCT02772198
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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