Phase
Condition
Lymphoma, B-cell
Lymphoma
Anger
Treatment
Glofitamab
MEN1703
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥18 years old
Documented histological confirmation of aggressive B-cell non-Hodgkin lymphomaincluding DLBCL NOS and transformed indolent B-cell lymphoma
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)
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.
Availability of lymph node tissue at Screening (or archival sample) (part 2participants only)
Life expectancy of ≥12 weeks.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
Adequate organ function at Screening
Adequate hematologic function
Exclusion
Exclusion Criteria:
Primary central nervous system (CNS) lymphoma or CNS involvement by lymphoma atscreening.
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.
Concurrent participation in another therapeutic clinical study.
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.
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
Contraindication to all uric acid lowering agents.
Major surgery within 1 month prior to first dose of study drug.
Hematopoietic stem cell transplant within 4 months prior to first dose of studydrug.
Requires systemic immune-modulating therapy (regardless of dose) or has confirmedhistory or current autoimmune disease or other diseases resulting in permanentimmunosuppression.
Exposed to live or live attenuated vaccine(s) within 4 weeks prior to signing theinformed consent form (ICF).
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.
Known human immunodeficiency virus (HIV) infection
Current active liver disease from any cause
Ongoing drug-induced pneumonitis.
Ongoing inflammatory bowel disease.
Active known second malignancy
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.
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.
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.
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.
Any disease, syndrome or condition which may significantly affect drug intake viaoral route.
Planning to become pregnant or breastfeed during treatment and for 1 month after thelast dose of study drug.
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
Study Description
Connect with a study center
Centre Hospitalier Le Mans
Le Mans, 72037
FranceSite Not Available
CHU de Limoges - CHU Dupuytren
Limoges CEDEX 1, 87042
FranceSite Not Available
Hospices Civils De Lyon - Hôpital Lyon Sud
Lyon, 69310
FranceActive - Recruiting
CHU Montpellier - Hôpital Saint Eloi
Montpellier, 34490
FranceActive - Recruiting
APHP - Hôpital Pitié-Salpêtrière
Paris cedex 13, 75651
FranceSite Not Available
CHU de Bordeaux - Hôpital Haut-Lévêque
Pessac, 33600
FranceSite Not Available
Wojewódzki Szpital Specjalistyczny w Białej Podlaskiej
Biała Podlaska,
PolandActive - Recruiting
Szpitale Pomorskie Sp. z o.o.
Gdynia,
PolandSite Not Available
Narodowy Instytut Onkologii im. Marii Skłodowskiej Curie, Państwowy Instytut Badawczy
Gliwice,
PolandActive - Recruiting
Pratia Hematologia Sp. z o.o.
Katowice,
PolandActive - Recruiting
Pratia MCM Kraków
Kraków,
PolandActive - Recruiting
Uniwersytecki Szpital Kliniczny nr 1 w Lublinie
Lublin,
PolandSite Not Available
Szpital Kliniczny Ministerstwa Spraw Wewnętrznych i Administracji z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn,
PolandActive - Recruiting
Wojewódzki Szpital Zespolony im. L. Rydygiera w Toruniu
Toruń,
PolandSite Not Available
Lux Med Onkologia Sp. z o.o.
Warsaw,
PolandActive - Recruiting
Wojskowy Instytut Medyczny - Państwowy Instytut Badawczy
Warsaw,
PolandSite Not Available
Hospital Universitari Vall D Hebron
Barcelona, 08035
SpainSite Not Available
Hospital Clínico Uni versitario Virgen de la Arrixaca
El Palmar, Murcia, 30120
SpainSite Not Available
Clinica Universidad De Navarra
Madrid, 28027
SpainActive - Recruiting
MD Anderson Cancer Center
Madrid, 28033
SpainSite Not Available
Clinica Universidad De Navarra
Pamplona, 31008
SpainActive - Recruiting
Hospital Universitario De Navarra
Pamplona Navarra, 31008
SpainSite Not Available
Hospital Universitario De Salamanca
Salamanca, 37007
SpainSite Not Available
Hospital Universitario Virgen De La Macarena
Seville, 41009
SpainSite Not Available
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