Neoplasms

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Lymphoma, Large B-Cell, Diffuse

Lymphoma

Lymphoma, Follicular

Lymphoma, B-Cell

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

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All Drugs and Chemicals

Antibodies

Antibodies, Bispecific

Immunoglobulins

AZD0486 monotherapy will be administered intravenously on day 1 and 15 of 28 day cycles for a maximum of 24 cycles or until disease progression. Depending on cohort, subjects may receive priming or step-up dosing during cycle 1 before reaching the target dose. While on study, subjects will be monitored for safety and efficacy with periodic disease assessment with PET/CT. If subject achieves two consecutive CRs after completing C6, then they may be eligible for monthly dosing

An expansion cohort in subjects with DLBCL or HGBL will be enrolled after RP2D is established.

An expansion cohort in subjects with FL will be enrolled after RP2D is established.

AZD0486 is a bispecific antibody targeting CD19 on tumor cells and CD3 on T-cells leading to T cell-mediated cytotoxicity of malignant B cells

AZD0486 IV

AstraZeneca Clinical Study Information Center

David Sermer, MD

This phase 1 study will investigate the safety, tolerability, pharmacokinetic, pharmacodynamic, and clinical activity of AZD0486, a CD19 x CD3 T-cell engaging bispecific antibody, in subjects with relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL) who have received 2 or more prior lines of therapy.

The study consists of 3 parts. Part 1 Arm A is a dose escalation study allowing the assessment of safety, tolerability, PK and PD profiles of single-agent AZD0486.

Part 2 Arm B will evaluate the MTD (or RP2D) of AZD0486 monotherapy in subjects with biopsy proven RR DLBCL and HGBL. This will be initiated once expansion dose has been selected based on data from Part 1 Arm A.

Part 2 Arm C evaluate the MTD (or RP2D) of AZD0486 monotherapy in subjects with biopsy proven RR FL. Arm C will be initiated once the expansion dose for FL has been selected based on data from the Monotherapy Dose Escalation (Part 1, Arm A).

The expansion dose and dosing frequency for Part 2 will be chosen by the SMG based on safety, tolerability, and PK/PD data collected during the dose escalation portion of the study.

The study will consist of 2 parts; In the monotherapy dose escalation part (Part 1, Arm A), adult subjects with RR B-NHL who have received 2 or more prior lines of therapy will be enrolled into cohorts of incrementally increasing doses.

Dose escalation will proceed based on emerging safety, efficacy, and PK/PD data and after review by safety monitoring group (SMG)

The monotherapy dose expansion in refractory or relapsed (RR) diffuse large B-cell lymphoma (DLBCL)/ high-grade B-cell lymphoma (HGBL) (Part 2, Arm B) or RR follicular lymphoma (FL) (Grade 1-3a) (Part 2, Arm C) will be initiated after MTD (or RP2D) has been selected based on data from Part 1, Arm A. Arm B and Arm C will evaluate the MTD (or RP2D) of AZD0486 in subjects with RR DLBCL/HGBL or RR FL to evaluate safety, tolerability, and the relationship between pharmacodynamic markers and PK, safety and clinical response

A Study of AZD0486 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of AZD0486, a Bispecific Antibody Targeting CD19 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Supporting

A DLT is defined as a TEAE that is not unequivocally due to the subject's underlying malignancy or other extraneous cause. DLT evaluable subjects are defined as those subjects who receive either the target dose of AZD0486 or priming dose(s) in any step-up dose schedule and are assessed for toxicities for the 28-day evaluation period.

The NCI-CTCAE version 5.0 will be used (except for CRS and NT). A DLT will be evaluated as Non-hematologic, Hematologic, Cytokine Release Syndrome (CRS), or neurotoxicity.

The incidence, timing, seriousness, and relationship to study treatment of adverse events will be evaluated.

The maximum observed serum concentration on a concentration time curve.

Area under the serum concentration-time curve from time zero to time of last measurable concentration.

Terminal half-life (t1/2,) will be determined after infusion in Cycle 1 using non-compartmental methods.

Objective response rate is defined as the proportion of subjects with a confirmed partial or complete response to treatment

Progression-free survival time is defined as the time from the first dose of AZD0486 to progression or death, whichever occurs first

The duration of objective response for a subject is defined as the time from the initial objective response to disease progression or death, whichever occurs first

Clinical benefit rate is defined as the proportion of subjects with a confirmed complete response, partial response or minor response, or stable disease for at least 24 weeks after responding to treatment

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of AZD0486 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma	NCT04594642	B-cell Non Hodg... Diffuse Large B... High-grade B-ce... Follicular Lymp...	AZD0486 IV	18 Years - 130 Years	AstraZeneca
A Study of AZD0486 in Subjects With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma	NCT04594642	B-cell Non Hodg... Diffuse Large B... High-grade B-ce... Follicular Lymp...	AZD0486 IV	18 Years - 130 Years	AstraZeneca

Spots Global Cancer Trial Database for azd0486 iv

Every month we try and update this database with for azd0486 iv cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for azd0486 iv

Every month we try and update this database with for azd0486 iv cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for azd0486 iv cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.