AZD5492
DrugCD8/TCR based T-cell engaging antibody targeting CD20, which is administered subcutaneously
NCT Number: NCT06542250
This is a Phase I/II study designed to evaluate if experimental T cell engaging antibody targeting CD20 AZD5492 is safe, tolerable and efficacious in participants with Relapsed or Refractory B-Cell Malignancies.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Research Site, Melbourne, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
The above is a summary, other inclusion criteria details may apply.
Exclusion criteria
The above is a summary, other exclusion criteria details may apply.
CD8/TCR based T-cell engaging antibody targeting CD20, which is administered subcutaneously
Time frame: Module 1 - From the first administration of AZD5492 until the end of cycle 1 (up to 5 weeks).
DLTs are dose-limiting toxicities as defined in the study protocol.
Time frame: Module 1 - From the first administration of AZD5492 within the duration of the treatment period, up to and including 90 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy.
Incidence and severity of AEs, AESIs, and SAEs
Time frame: Module 1 - From the first administration of AZD5492 within the duration of the treatment period, up to and including 90 (+7) days after the last dose of study treatment , but prior to subsequent cancer therapy.
SAEs/AEs leading to discontinuation of AZD5492.
Time frame: Module 1 - From first dose of AZD5492 up to 2 years after last dose.
The proportion of participants with a complete response or partial response, according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL.
Time frame: Module 1 - From first dose of AZD5492 up to 2 years after last dose.
The proportion of participants with a complete response (CR), according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL.
Time frame: Module 1 - From first dose of AZD5492 up to 2 years after last dose.
The time from the date of first documented response until the date of documented progression (according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL) or death due to any cause.
Time frame: Module 1 - From first dose of AZD5492 up to 2 years after last dose.
The time from the date of first dose until the date of documented disease progression (according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL) or death due to any cause.
Time frame: Module 1 - From first dose of AZD5492 up to 2 years after last dose.
The time from the date of first dose until date of death due to any cause.
Time frame: Module 1 - From informed consent until 90 days after last dose of AZD5492.
Maximum observed serum concentration of AZD5492.
Time frame: Module 1 - From informed consent until 90 days after last dose of AZD5492.
Maximum observed plasma concentration of AZD5492.
Time frame: Module 1 - From informed consent until 90 days after last dose of AZD5492.
Area under the plasma concentration-time curve.
Time frame: Module 1 - From informed consent until 90 days after last dose of AZD5492.
The volume of plasma from which the study drug is completely removed per unit time.
Time frame: Module 1 - From informed consent until 90 days after last dose of AZD5492.
Terminal elimination half-life.
Time frame: Module 1 - From informed consent until 90 days after last dose of AZD5492.
The number of participants who develop ADAs measured in serum.
Time frame: Module 1 - From informed consent until 90 days after last dose of AZD5492.
The percentage of participants who develop ADAs measured in serum.
Contact information is provided by the study sponsor or research team.
AstraZeneca
Industry
A Modular Phase I/II Open-label Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of AZD5492, a T Cell-engaging Antibody Targeting CD20 in Subjects With Relapsed or Refractory B-Cell Malignancies (TITANium)
Acronym: TITANium
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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