MEN1703 (SEL24) to Treat Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma (JASPIS-01)

Last updated: April 8, 2025
Sponsor: Ryvu Therapeutics SA
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma, B-cell

Lymphoma

Anger

Treatment

Glofitamab

MEN1703

Clinical Study ID

NCT06534437
JASPIS-01
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years old

  2. Documented histological confirmation of aggressive B-cell non-Hodgkin lymphomaincluding DLBCL NOS and transformed indolent B-cell lymphoma

  3. Relapsed or refractory disease having received at least 2 prior lines of systemictreatment and, naïve to anti-CD3xCD20 bispecific antibody treatment (group 1) orexhausted all standard, available treatment options (group 2)

  4. At least 1 measurable site of disease based on computed tomography (CT) or positronemission tomography (PET)-CT scan with involvement of 2 or more clearly demarcatedlesions and or nodes.

  5. Availability of lymph node tissue at Screening (or archival sample) (part 2participants only)

  6. Life expectancy of ≥12 weeks.

  7. Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2

  8. Adequate organ function at Screening

  9. Adequate hematologic function

Exclusion

Exclusion Criteria:

  1. Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma atscreening.

  2. Received anti-cancer treatments, including cytotoxic chemotherapy, radiotherapy,hormonal therapy, biologic, immunotherapy, or investigational drugs within 14 daysor 5 half-lives (whichever is shorter) before the first dose of study drug. Priortreatment with CAR-T cell or an anti-CD3xCD20 bispecific antibody therapy (permittedfor Group 2 only), requires a wash out period of ≥4 weeks.

  3. Concurrent participation in another therapeutic clinical study.

  4. Ongoing clinically significant toxicity (for example, alopecia is not clinicallysignificant) from any prior anti-cancer therapy that has not resolved to Grade 1 orless prior to the first dose of study drug.

  5. Prior treatment with a PIM inhibitor.

  6. Group 1 only: Any prior therapy with a bispecific antibody targeting CD3 and CD20.

  7. Known risk of allergy to the study drugs, MEN1703 (group 1 and 2) or glofitamab (group 1) or their excipients

  8. Contraindication to all uric acid lowering agents.

  9. Major surgery within 1 month prior to first dose of study drug.

  10. Hematopoietic stem cell transplant within 4 months prior to first dose of studydrug.

  11. Requires systemic immune-modulating therapy (regardless of dose) or has confirmedhistory or current autoimmune disease or other diseases resulting in permanentimmunosuppression.

  12. Exposed to live or live attenuated vaccine(s) within 4 weeks prior to signing theinformed consent form (ICF).

  13. Evidence of ongoing and uncontrolled systemic bacterial, fungal, or viral infection,except for documented Grade Common Terminology Criteria for Adverse Events (CTCAE) ≤2 infections with evidence of improvement or without evidence of worseninginfection.

  14. Known human immunodeficiency virus (HIV) infection

  15. Current active liver disease from any cause

  16. Ongoing drug-induced pneumonitis.

  17. Ongoing inflammatory bowel disease.

  18. Active known second malignancy

  19. Received an agent known to be a sensitive CYP2D6 substrate or a CYP2D6 substratewith a narrow therapeutic range, a strong or moderate CYP2D6 inhibitor, or a BCRPinhibitor within 14 days or 5 half-lives (whichever is shorter), prior to the firstdose of study drug.

  20. Cardiac dysfunction is defined as myocardial infarction within 6 months of studyentry, New York Heart Association (NYHA) Class III or IV heart failure, uncontrolleddysrhythmias, or poorly controlled angina.

  21. Receiving treatment for active, ongoing thromboembolic event. Note: Does not applyto prophylactic treatment to prevent or avoid reoccurrence of a prior resolvedevent. To review with Medical Monitor where further risk assessment is needed.

  22. History of serious ventricular arrhythmia (e.g., VT or VF, ≥3 beats in a row), or QTinterval corrected for heart rate (QTc) ≥480 ms. Note: QTc values up to 500 ms will be acceptable where patient's medical historye.g., bundle branch block, is known to cause mild QTc prolongation and the conditionis well controlled.

  23. Any disease, syndrome or condition which may significantly affect drug intake viaoral route.

  24. Planning to become pregnant or breastfeed during treatment and for 1 month after thelast dose of study drug.

  25. Any other prior or current medical condition, intercurrent illness, surgicalhistory, physical or 12-lead electrocardiogram (ECG) findings, laboratoryabnormalities, or extenuating circumstance (e.g., alcohol or drug addiction) that,in the investigator's opinion, could jeopardize patient safety or interfere with theobjectives of the study.

Study Design

Total Participants: 178
Treatment Group(s): 2
Primary Treatment: Glofitamab
Phase: 2
Study Start date:
December 05, 2024
Estimated Completion Date:
December 31, 2026

Study Description

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.

Connect with a study center

  • Centre Hospitalier Le Mans

    Le Mans, 72037
    France

    Site Not Available

  • CHU de Limoges - CHU Dupuytren

    Limoges CEDEX 1, 87042
    France

    Site Not Available

  • Hospices Civils De Lyon - Hôpital Lyon Sud

    Lyon, 69310
    France

    Active - Recruiting

  • CHU Montpellier - Hôpital Saint Eloi

    Montpellier, 34490
    France

    Active - Recruiting

  • APHP - Hôpital Pitié-Salpêtrière

    Paris cedex 13, 75651
    France

    Site Not Available

  • CHU de Bordeaux - Hôpital Haut-Lévêque

    Pessac, 33600
    France

    Site Not Available

  • Wojewódzki Szpital Specjalistyczny w Białej Podlaskiej

    Biała Podlaska,
    Poland

    Active - Recruiting

  • Szpitale Pomorskie Sp. z o.o.

    Gdynia,
    Poland

    Site Not Available

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej Curie, Państwowy Instytut Badawczy

    Gliwice,
    Poland

    Active - Recruiting

  • Pratia Hematologia Sp. z o.o.

    Katowice,
    Poland

    Active - Recruiting

  • Pratia MCM Kraków

    Kraków,
    Poland

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny nr 1 w Lublinie

    Lublin,
    Poland

    Site Not Available

  • Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie

    Olsztyn,
    Poland

    Active - Recruiting

  • Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu

    Toruń,
    Poland

    Site Not Available

  • Lux Med Onkologia Sp. z o.o.

    Warsaw,
    Poland

    Active - Recruiting

  • Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy

    Warsaw,
    Poland

    Site Not Available

  • Hospital Universitari Vall D Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Clínico Uni versitario Virgen de la Arrixaca

    El Palmar, Murcia, 30120
    Spain

    Site Not Available

  • Clinica Universidad De Navarra

    Madrid, 28027
    Spain

    Active - Recruiting

  • MD Anderson Cancer Center

    Madrid, 28033
    Spain

    Site Not Available

  • Clinica Universidad De Navarra

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Hospital Universitario De Navarra

    Pamplona Navarra, 31008
    Spain

    Site Not Available

  • Hospital Universitario De Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hospital Universitario Virgen De La Macarena

    Seville, 41009
    Spain

    Site Not Available

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