Study identifier:D7407C00001
ClinicalTrials.gov identifier:NCT06564038
EudraCT identifier:N/A
CTIS identifier:2024-515034-33-00
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
Chronic lymphocytic leukaemia
Phase 1/2
No
AZD0486, Prednisone (or equivalent), Rituximab, Cyclophosphamide, Vincristine, Doxorubicin, Acalabrutinib
All
276
Interventional
18 Years - n/a
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Aug 2025 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Substudy 1 (RR CLL/SLL): Cohort 1A (AZD0486 Monotherapy) Participants will receive AZD0486 monotherapy as subcutaneous (SC) injection. | Drug: AZD0486 AZD0486 will be administered as either SC injection or IV infusion. Other Name: TNB-486 Other Name: Surovatamig |
Experimental: Substudy 1 (RR CLL/SLL): Cohort 1B (AZD0486 + Acalabrutinib) Participants will receive AZD0486 as SC injection. Participants will receive acalabrutinib tablet orally twice daily. | Drug: AZD0486 AZD0486 will be administered as either SC injection or IV infusion. Other Name: TNB-486 Other Name: Surovatamig Drug: Acalabrutinib Acalabrutinib will be administered orally |
Experimental: Substudy 1 (RR CLL/SLL): Cohort 1C (AZD0486 Monotherapy) Participants will receive AZD0486 monotherapy as intravenous (IV) infusion. | Drug: AZD0486 AZD0486 will be administered as either SC injection or IV infusion. Other Name: TNB-486 Other Name: Surovatamig |
Experimental: Substudy 2 (RR MCL): Cohort 2A (AZD0486 Monotherapy) Participants will receive AZD0486 monotherapy as SC injection. | Drug: AZD0486 AZD0486 will be administered as either SC injection or IV infusion. Other Name: TNB-486 Other Name: Surovatamig |
Experimental: Substudy 2 (RR MCL): Cohort 2C (AZD0486 Monotherapy) Participants will receive AZD0486 monotherapy as IV infusion. | Drug: AZD0486 AZD0486 will be administered as either SC injection or IV infusion. Other Name: TNB-486 Other Name: Surovatamig |
Experimental: Substudy 3 (LBCL): AZD0486 + R-CHOP Participants will receive AZD0486 as IV infusion in combination with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) chemotherapy. | Drug: AZD0486 AZD0486 will be administered as either SC injection or IV infusion. Other Name: TNB-486 Other Name: Surovatamig Drug: Prednisone (or equivalent) Prednisone (or equivalent) will be administered either oral or IV infusion as per standard of care. Drug: Rituximab Rituximab will be administered as IV infusion as per standard of care. Drug: Cyclophosphamide Cyclophosphamide will be administered as IV infusion as per standard of care. Drug: Vincristine Vincristine will be administered as IV infusion as per standard of care. Drug: Doxorubicin Doxorubicin will be administered as IV infusion as per standard of care. |