BridgeMD
A trial to learn if AZD0486 alone or with other anticancer drugs is safe and works in adults with certain blood cancers
EU CTIS ID: 2024-515034-33-00
What this study is testing
To assess safety and tolerability and determine the RP2D (recommended Phase II dose) of surovatamig (administered as IV or SC) as monotherapy and in combination with other anticancer agents across mature B-cell malignancies
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- All sub- studies: Age ≥ 18 years
- Sub- study 2, Cohort 2A and Cohort 2C: Relapsed or Progressed after 2 or more prior systemic therapy for MCL including BTKi
- Sub-study 3A: Previously untreated LBCL by WHO 2022 classification of lymphoid neoplasms OR Relapsed or refractory B-cell NHL after at least 1 prior lines of systemic therapy, Histologically confirmed according to WHO 2022 classification (excluding some B-NHL subtypes)
- Sub-study 3: LVEF >50%
- Sub-study 3A: IPI 2-5 for participants with untreated LBCL diagnoses
- Sub-study 3: At least 1 measurable site as per Lugano
You likely can't join if
- All sub- studies: CNS lymphoma
- Sub-study 3: Cumulative dose of anthracycline > 150 mg/m2
- All sub- studies: Major Surgical procedure within 14 days before the first dose of study drug
- All sub- studies: Clinically significant CV disease
- All sub- studies: Unresolved non-haematological Grade ≥ 2 AEs (NCI CTCAE V5.0) from prior anticancer therapy (except alopecia or fatigue)
- All sub-studies: Any anticancer systemic therapy within 5 half-lives or 21 days (whichever is shorter) prior to Cycle 1 Day 1
See the full eligibility criteria
- All sub- studies: Age ≥ 18 years
- Sub- study 2, Cohort 2A and Cohort 2C: Relapsed or Progressed after 2 or more prior systemic therapy for MCL including BTKi
- Sub-study 3A: Previously untreated LBCL by WHO 2022 classification of lymphoid neoplasms OR Relapsed or refractory B-cell NHL after at least 1 prior lines of systemic therapy, Histologically confirmed according to WHO 2022 classification (excluding some B-NHL subtypes)
- Sub-study 3: LVEF >50%
- Sub-study 3A: IPI 2-5 for participants with untreated LBCL diagnoses
- Sub-study 3: At least 1 measurable site as per Lugano
- Sub-study 1B: Contraception during treatment and until at least x days after the last dose of Surovatamig and until 2 days after the last dose of acalabrutinib, whichever is longer.
- All sub- studies: ECOG performance status 0 to 2
- Sub-study 3: Contraception until x days after the last dose of surovatamig, 4 months after the last dose of vincristine, and 6 months after the last dose of cyclophosphamide or doxorubicin, (or as required by local prescribing information) whichever is longer.
- All sub-studies: Contraception during treatment and at least x days after final dose
- All sub- studies: Confirmed CD19 expression if prior anti-CD19 therapy
- Sub-study 1, Cohort 1A and Cohort 1C: at least 2 prior lines of systemic therapy for CLL/SLL including treatment with a BTKi and BCL2i
- Sub-study 1: CLL/SLL diagnosis and meets iwCLL criteria for treatment
- Sub-study 1: SLL: at least 1 measurable site per Lugano
- Sub-study 1: Absolute lymphocytes <25,000 cells/mcl
- Sub study 3B: Histologically confirmed diagnosis of previously untreated LBCL by WHO 2022 classification of lymphoid neoplasms
- Sub study 3B: For all participants: IPI score of 2 to 5.
- Sub-study 3: Participant must be no older than 79 years of age at the time of signing ICF
- Sub-study 1, Cohort 1B: at least 1 prior line of therapy and BTKi sensitive
- Sub-study 2: MCL diagnosis per WHO
- Sub-study 3: Absolute lymphocytes count of < 5 × 109 cells/L
- Sub-study 3: Haemoglobin ≥ 9 g/dL
- Sub-study 2: Clinical Stage II, III, or IV per Ann Arbor classification
- Sub-study 2: At least 1 measurable site per Lugano
- Sub-study 2: ALC < 25,000 cells/mcL
- All sub- studies: CNS lymphoma
- Sub-study 3: Cumulative dose of anthracycline > 150 mg/m2
- All sub- studies: Major Surgical procedure within 14 days before the first dose of study drug
- All sub- studies: Clinically significant CV disease
- All sub- studies: Unresolved non-haematological Grade ≥ 2 AEs (NCI CTCAE V5.0) from prior anticancer therapy (except alopecia or fatigue)
- All sub-studies: Any anticancer systemic therapy within 5 half-lives or 21 days (whichever is shorter) prior to Cycle 1 Day 1
- Prior allogenic HSCT or solid organ transplantation within 24 weeks of starting Cycle 1 Day 1
- All sub-studies: Radiation therapy within 28 days of Cycle 1 Day 1
- All sub-studies: Prior CAR-T therapy or auto-HSCT within 12 weeks or prior TCE within 8 weeks of Cycle 1 Day 1
- All sub-studies: Prior Grade ≥ 3 CRS or ICANS event
- Sub-study 1: CLL transformation to more aggressive lymphoma
- All sub-studies: Active, significant, or uncontrolled infection or autoimmune disease requiring systemic therapy which places participant at unacceptable risk if he/she were to participate in the study
- Sub-study 1, Cohort 1B: bleeding diathesis, treatment with strong CYP3A inhibitor or inducer, history of ICH or stroke within 24 weeks, GI malabsorption, receiving vitamin K antagonist
- Sub-study 2 Exclusion Criteria Refer to Section 5.2 of the Master Protocol.
- Sub-study 3: Mediastinal grey-zone lymphoma, Burkitt, Richter’s transformation, primary effusion LBCL
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- China
- Taiwan
- Korea, Republic of
- United Kingdom
- United States
- Japan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; China; Taiwan; Korea, Republic of; United Kingdom; United States and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.