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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Module 1: AZD5492 Monotherapy | Experimental | AZD5492 monotherapy for Relapsed or Refractory B-Cell Malignancies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD5492 | Drug | CD8/TCR based T-cell engaging antibody targeting CD20, which is administered subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of dose limiting toxicities (DLTs). | DLTs are dose-limiting toxicities as defined in the study protocol. | Module 1 - From the first administration of AZD5492 until the end of cycle 1 (up to 5 weeks). |
| Safety evaluation of AZD5492: Number of participants with treatment-related adverse events. | Incidence and severity of AEs, AESIs, and SAEs | 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. |
| Tolerability evaluation of AZD5492: Number of participants with treatment-related adverse events. | SAEs/AEs leading to discontinuation of AZD5492. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | The proportion of participants with a complete response or partial response, according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL. | Module 1 - From first dose of AZD5492 up to 2 years after last dose. |
| Complete Response Rate (CR Rate) |
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Inclusion Criteria:
≥18 years of age;
Histologically documented CD20+ mature B-cell neoplasm
Relapsed, progressive and/or refractory disease following at least 2 prior lines of therapy;
ECOG performance status of ≤ 2 (< 2 in EU countries).
The above is a summary, other inclusion criteria details may apply.
Exclusion Criteria:
The above is a summary, other exclusion criteria details may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | La Jolla | California | 92093 | United States | |
| Research Site |
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://www.astrazenecaclinicaltrials.com/our-transparency-commitments/.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://www.astrazenecaclinicaltrials.com/our-transparency-commitments/.
When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
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The study consists of individual modules each evaluating the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary efficacy of AZD5492 as monotherapy or in combination with other anticancer treatments in participants with R/R B-cell malignancies.
- Module 1: AZD5492 Monotherapy
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The proportion of participants with a complete response (CR), according to Lugano criteria for malignant lymphoma and iwCLL 2018 criteria for CLL. |
| Module 1 - From first dose of AZD5492 up to 2 years after last dose. |
| Duration of Response (DoR) | 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. | Module 1 - From first dose of AZD5492 up to 2 years after last dose. |
| Progression-free Survival (PFS) | 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. | Module 1 - From first dose of AZD5492 up to 2 years after last dose. |
| Overall Survival (OS) | The time from the date of first dose until date of death due to any cause. | Module 1 - From first dose of AZD5492 up to 2 years after last dose. |
| Pharmacokinetics of AZD5492: serum concentration of study drug | Maximum observed serum concentration of AZD5492. | Module 1 - From informed consent until 90 days after last dose of AZD5492. |
| Pharmacokinetics of AZD5492: Maximum plasma concentration of the study drug (Cmax). | Maximum observed plasma concentration of AZD5492. | Module 1 - From informed consent until 90 days after last dose of AZD5492. |
| Pharmacokinetics of AZD5492: Area under the concentration time curve (AUC). | Area under the plasma concentration-time curve. | Module 1 - From informed consent until 90 days after last dose of AZD5492. |
| Pharmacokinetics of AZD5492: apparent clearance | The volume of plasma from which the study drug is completely removed per unit time. | Module 1 - From informed consent until 90 days after last dose of AZD5492. |
| Pharmacokinetics of AZD5492: Half-life (t 1/2) | Terminal elimination half-life. | Module 1 - From informed consent until 90 days after last dose of AZD5492. |
| To determine the immunogenicity of AZD5492 | The number of participants who develop ADAs measured in serum. | Module 1 - From informed consent until 90 days after last dose of AZD5492. |
| To determine the immunogenicity of AZD5492 | The percentage of participants who develop ADAs measured in serum. | Module 1 - From informed consent until 90 days after last dose of AZD5492. |
| Withdrawn |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Research Site | Not yet recruiting | Rochester | Minnesota | 55905 | United States |
| Research Site | Recruiting | Hackensack | New Jersey | 07601 | United States |
| Research Site | Recruiting | New York | New York | 10021 | United States |
| Research Site | Recruiting | New York | New York | 10029 | United States |
| Research Site | Recruiting | Charlotte | North Carolina | 28203 | United States |
| Research Site | Recruiting | Winston-Salem | North Carolina | 27157 | United States |
| Research Site | Recruiting | Houston | Texas | 77030 | United States |
| Research Site | Recruiting | Seattle | Washington | 98109 | United States |
| Research Site | Recruiting | Melbourne | 3000 | Australia |
| Research Site | Recruiting | Nedlands | 6009 | Australia |
| Research Site | Recruiting | Calgary | Alberta | T2N 5G2 | Canada |
| Research Site | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
| Research Site | Recruiting | Montreal | Quebec | H3T 1R2 | Canada |
| Research Site | Recruiting | Hangzhou | 310003 | China |
| Research Site | Recruiting | Shanghai | 200025 | China |
| Research Site | Recruiting | København Ø | 2100 | Denmark |
| Research Site | Recruiting | Pessac | 33604 | France |
| Research Site | Recruiting | Villejuif | 94805 | France |
| Research Site | Recruiting | München | 81675 | Germany |
| Research Site | Recruiting | Ulm | 89081 | Germany |
| Research Site | Recruiting | Würzburg | 97080 | Germany |
| Research Site | Recruiting | Bologna | 40138 | Italy |
| Research Site | Recruiting | Milan | 20133 | Italy |
| Research Site | Recruiting | Chūōku | 104-0045 | Japan |
| Research Site | Recruiting | Kashiwa | 277-8577 | Japan |
| Research Site | Recruiting | Barcelona | 08035 | Spain |
| Research Site | Recruiting | L'Hospitalet de Llobregat | 08908 | Spain |
| Research Site | Recruiting | Madrid | 28040 | Spain |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D015448 | Leukemia, B-Cell |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D020522 | Lymphoma, Mantle-Cell |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
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