Trial NCT06564038
A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies
- Phase
- Phase 1/2
- Sponsor
- AstraZeneca
- Conditions
- Chronic Lymphocytic Leukaemia; Small Lymphocytic Lymphoma; Mantle-cell Lymphoma; Large B-cell Lymphoma; B-cell Non-Hodgkin Lymphoma
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
Inclusion Criteria:
Master Inclusion Criteria applicable to all substudies:
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.Performance status
* Contraception use during treatment and at least 90 days after final dose.
* Confirmed CD19 expression if prior anti-CD19 therapy.
Substudy 1 Specific Inclusion Criteria:
* Participants with CLL must require treatment according to the international workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria.
* SLL: at least 1 measurable site per Lugano.
* Absolute lymphocyte count (ALC) <25000 cells/mcL.
* Cohort 1A and 1C: at least 2 prior lines of systemic therapy for CLL/SLL.
* Cohort 1B: at least 1 prior line of therapy and is bruton tyrosine kinase inhibitor (BTKi)-sensitive.
Substudy 2 Specific Inclusion Criteria:
* MCL diagnosis per WHO.
* Clinical Stage II, III, or IV by Ann Arbor Classification.
* At least 1 measurable site per Lugano.
* ALC < 25000 cells/mcL.
* Cohort 2A and 2C: Relapse or progressed after 2 or more lines of therapy including BTKi.
Substudy 3 Specific Inclusion Criteria:
* At least 1 measurable site as per Lugano.
* Left ventricular ejection fraction (LVEF) ≥50%.Cardiac
* Participant must be no older than 79 years of age at the time of signing ICF.Age
* Contraception at least 90 days after last dose of surovatamig or 4 months after last dose of vincristine, and 6 months after the last dose of cyclophosphamide, or doxorubicin.
* Cohort 3A:
1. Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022.
2. R/R B-NHL after at least 1 prior lines of systemic therapy.
3. International Prognostic Index (IPI) 2-5.
* Cohort 3B:
1. Histologically confirmed diagnosis of previously untreated large B-cell Lymphoma (LBCL) per WHO 2022.
2. IPI score of 2 to 5.
Exclusion Criteria:
Master Exclusion Criteria applicable to all substudies:
* Central nervous system (CNS) lymphoma.Brain metastases
* Surgery within 14 days of study drug.
* Clinically significant cardiovascular (CV) disease.
* Unresolved Grade >2 AEs from prior anticancer therapy (except alopecia or fatigue).
* Any systemic therapy within 5 half-lives or 21 days (whichever is shorter) prior to treatment.
* Radiation therapy within 28 days.
* Prior CAR T-cell therapy or autologous-haematopoietic stem cell transplant (HSCT) within 12 weeks or prior T-cell engager (TCE) within 8 weeks.
* Prior Grade > 3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) event.
* Prior allogeneic HSCT or solid organ transplantation within 24 weeks of starting Cycle 1 Day 1.
* Active, significant, uncontrolled infection or autoimmune disease requiring systemic therapy including participants with known history of haemophagocytic lymphohistiocytosis (HLH).
Substudy 1 Specific Exclusion Criteria:
* CLL/SLL transformation to more aggressive form of lymphoma.
* Cohort 1B: bleeding diathesis, CYP3A inhibitor or inducer, history of ICH or stroke within 24 weeks, GI malabsorption, receiving vitamin K antagonist.
Substudy 3 Specific Exclusion Criteria:
* Mediastinal grey-zone lymphoma, Burkitt, Richter's transformation, primary effusion large B-cell lymphoma (LBCL).
* Cumulative dose of anthracycline >150 mg/m2.
Restrictions found (4)
- AgeOutrightinclusion
age <= 79
Show in the text - Brain metastasesOutrightexclusionShow in the text
- CardiacOutrightinclusion
LVEF >=50%
Show in the text - Performance statusOutrightinclusion
ECOG 0 to 2
Show in the text
Recruiting in Massachusetts
- Research Site · Boston, Suffolk County