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
This is open-label, multi-center study to evaluate the safety and preliminary efficacy of surovatamig administered as monotherapy and in combination with other anticancer agents in participants with mature B-cell hematologic malignancies. This master study currently includes 3 substudies and each substudy focusing on a defined population: Substudy 1: Relapsed/refractory (R/R) Chronic lymphocytic leukaemia (CLL)/ Small lymphocytic lymphoma (SLL) Substudy 2: R/R Mantle-cell lymphoma (MCL) Substudy 3: Large B-cell lymphoma (LBCL) or R/R B-cell non-Hodgkin lymphoma (B-NHL) (not applicable to US) The study will have the following sequential periods: 1. Screening period of 28 days 2. Treatment period 3. Follow-up period
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
408
Surovatamig will be administered as either SC injection or IV infusion.
Prednisone (or equivalent) will be administered either oral or IV infusion as per standard of care.
Rituximab will be administered as IV infusion as per standard of care.
Cyclophosphamide will be administered as IV infusion as per standard of care.
Vincristine will be administered as IV infusion as per standard of care.
Doxorubicin will be administered as IV infusion as per standard of care.
Acalabrutinib will be administered orally
Research Site
Boston, Massachusetts, United States
RECRUITINGResearch Site
Hackensack, New Jersey, United States
RECRUITINGResearch Site
New Brunswick, New Jersey, United States
RECRUITINGResearch Site
New York, New York, United States
Number of Participants with Adverse Events, Serious Adverse Events and Adverse Events of Special Interest
Safety and tolerability of surovatamig as monotherapy and in combination with other anticancer agents across mature B-cell malignancies.
Time frame: Up to 6 years 4 months
Number of Participants with Dose Limiting Toxicity (DLTs)
Safety and tolerability of surovatamig as monotherapy and in combination with other anticancer agents across mature B-cell malignancies.
Time frame: Up to 2 months
Overall Response Rate (ORR)
ORR is defined as percentage of participants achieving either a partial response (PR) or complete response (CR) based on response criteria for International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 and Lugano 2014 assessed by investigator (substudy 1) and percentage of participants achieving either PR or CR based on Lugano 2014 Response Criteria by investigator assessment (substudies 2 and 3).
Time frame: Up to 6 years 4 months
Complete Response (CR) Rate
CR rate is defined as percentage of participants achieving CR as best response based on response criteria for iwCLL 2018 and Lugano 2014 assessed by investigator (substudy 1) and percentage of participants achieving CR as best response based on Lugano 2014 Response Criteria by investigator assessment (substudies 2 and 3).
Time frame: Up to 6 years 4 months
Duration of Response (DoR)
DoR is defined as time from the date of first documented response until date of documented progression based on response criteria for iwCLL 2018 and Lugano 2014 assessed by investigator, relapse or death (substudy 1) and time from the date of first documented response until date of documented progression based on Lugano 2014 Response Criteria by investigator assessment, relapse or death (substudies 2 and 3).
Time frame: Up to 6 years 4 months
Maximum Observed Concentration (Cmax)
The PK (Cmax) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.
Time frame: Up to 90 days after last dose
Area Under the Concentration-time Curve (AUC)
The PK (AUC) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.
Time frame: Up to 90 days after last dose
Minimum Observed Concentration (Cmin)
The PK (Cmin) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.
Time frame: Up to 90 days after last dose
Time to Reach Maximum Concentration (tmax)
The PK (tmax) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.
Time frame: Up to 90 days after last dose
Trough Plasma Concentration (Ctrough)
The PK (Ctrough) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.
Time frame: Up to 90 days after last dose
Half Life (t1/2) of surovatamig
The PK (t1/2) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.
Time frame: Up to 90 days after last dose
Clearance (CL) of surovatamig
The PK (CL) of surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.
Time frame: Up to 90 days after last dose
Number of Participants with Anti-drug Antibody (ADA) for surovatamig
The incidence of immunogenicity of SC surovatamig as monotherapy and in combination with other anti-cancer agents will be evaluated.
Time frame: Up to 90 days after last dose
AstraZeneca Clinical Study Information Center
CONTACT
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Research Site
New York, New York, United States
WITHDRAWNResearch Site
Charlotte, North Carolina, United States
RECRUITINGResearch Site
Charlotte, North Carolina, United States
NOT_YET_RECRUITINGResearch Site
Columbus, Ohio, United States
RECRUITINGResearch Site
Portland, Oregon, United States
RECRUITINGResearch Site
Philadelphia, Pennsylvania, United States
RECRUITING...and 55 more locations