RightFit
RecruitingPhase 1 / Phase 2

A Study of AZD0486 Monotherapy or in Combination With Other Anti-Cancer Agents for Mature B-Cell Malignancies

A Phase I/II Open-Label Multi-Centre Master Protocol to Evaluate the Safety and Efficacy of AZD0486 Monotherapy or in Combination With Other Anticancer Agents in Participants With Mature B-Cell Malignancies

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe surovatamig (formerly AZD0486) is and how well it works, alone or with other cancer drugs. It is for people with certain B-cell blood cancers, including some types of leukemia and lymphoma.

The purpose of this study is to assess the safety and efficacy of surovatamig (formerly AZD0486) administered as monotherapy or in combination with other anticancer agents in participants with hematological malignancies

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be able to care for yourself and be up and about for at least half of your waking hours.
  • You must use birth control during treatment and for at least 90 days afterward. Some study drugs require 4 or 6 months afterward.
  • If you previously had treatment targeting CD19, your cancer must still have this marker.
  • Substudy 1: You must have chronic lymphocytic leukemia (CLL) that needs treatment or small lymphocytic lymphoma (SLL) with at least one measurable cancer site.
  • Substudy 1: Groups 1A and 1C require at least two past treatment courses. Group 1B requires at least one and cancer that still responds to a BTK inhibitor, a type of cancer drug.
  • Substudies 1 and 2: Your lymphocyte count, a type of white blood cell count, must be below 25,000 cells per microliter.
  • Substudy 2: You must have stage II, III, or IV mantle cell lymphoma with a measurable cancer site. Groups 2A and 2C require cancer that returned or worsened after at least two treatment courses, including a BTK inhibitor.
  • Substudy 3: You must be age 79 or younger, have a measurable cancer site, and have a heart pumping measure of at least 50%. Groups have specific lymphoma and past-treatment rules and require a lymphoma risk score of 2–5.

Who can't join

  • Lymphoma in the brain or spinal cord, or serious heart or blood vessel disease.
  • Surgery within 14 days or radiation within 28 days before study treatment. Other whole-body cancer treatment also requires a waiting period.
  • CAR T-cell treatment or a transplant using your own blood-forming stem cells within 12 weeks; or a T-cell engager, a drug that directs immune cells at cancer, within 8 weeks.
  • A transplant using donor blood-forming stem cells or a donated organ within 24 weeks before study treatment.
  • Past cancer treatment side effects above grade 2 that have not cleared, except hair loss or tiredness. Past immune reactions or related brain and nerve problems above grade 3 also exclude you.
  • An active, serious, uncontrolled infection or an autoimmune disease needing whole-body treatment. A history of HLH, a severe overreaction of the immune system, also excludes you.
  • Substudy 1: CLL or SLL that changed into a faster-growing lymphoma. Group 1B also excludes certain bleeding problems, medicines, trouble absorbing food or drugs, and a brain bleed or stroke within 24 weeks.
  • Substudy 3: Certain lymphoma types are excluded, including mediastinal grey-zone lymphoma, Burkitt lymphoma, Richter’s transformation, and primary effusion large B-cell lymphoma. Past anthracycline chemotherapy totaling more than 150 mg per square meter of body size also excludes you.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: Master Inclusion Criteria applicable to all substudies: * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. * 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%. * Participant must be no older than 79 years of age at the time of signing ICF. * 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. * 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.

Study sites (13)

MA

NC

NJ

NY

OH

OR

PA

RI

TX