A trial to learn if AZD5492 is safe and works alone and in combination with other cancer treatments in adults with B-cell blood cancers.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AstraZeneca AB

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Hemic and Lymphatic Diseases [C15]

Trial duration

12 Dec 2024 → ongoing

Decision date (initial)

2024-10-27

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

The objective of the study is to assess the safety and tolerability of AZD5492 as monotherapy or in combination with other anticancer agents in participants with R/R B-cell malignancies.

Secondary objectives 3

1. To evaluate the preliminary antitumor activity of AZD5492 as monotherapy or in combination with other anticancer agents in participants with R/R B-cell malignancies.
2. To characterize the PK of AZD5492 as monotherapy or in combination with other anticancer agents in participants with R/R B-cell malignancies
3. To determine the immunogenicity of AZD5492 as monotherapy or in combination with other anticancer agents in participants with R/R B-cell malignancies

Conditions and MedDRA coding

B-Cell Malignancies

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. ≥18 years of age
2. Histologically documented CD20+ mature B-cell neoplasm
3. Large B-cell lymphoma
4. Follicular lymphoma
5. Mantle cell lymphoma
6. Chronic lymphocytic leukemia
7. Small lymphocytic lymphoma
8. Relapsed, progressive and/or refractory disease following at least 2 prior lines of therapy
9. ECOG performance status of = 2 (Note: in EU countries this inclusion is ECOG performance status of < 2).
10. The above is a summary, other inclusion criteria details may apply

Exclusion criteria 8

1. Any neoplasm histology not specified in the IC section
2. Active CNS involvement in lymphoma or CNS pathology.
3. CNS pathology including but not limited to any history of seizure disorder/epilepsy
4. Prior allogeneic HSCT within 180 days, prior autologous HSCR within 90 days, or cell therapy within 90 days of start of therapy.
5. History of Grade ≥ 3 CRS or Grade ≥ 3 ICANS.
6. Active and uncontrolled infections.
7. Unresolved AEs ≥2 Grade, from prior therapies.
8. The above is a summary, other exclusion criteria details may apply.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Occurrence of Dose-Limiting Toxicities (DLTs)
2. Incidence and severity of AEs, AESIs, and SAEs
3. SAEs/AEs leading to discontinuation of AZD5492
4. Clinically significant alterations in vital signs and abnormal laboratory parameters

Secondary endpoints 3

1. Evaluate the preliminary antitumor activity of AZD5492 in participants with R/R B-cell malignancies, by looking at: - ORR (Overall Response Rate), CR Rate, DoR (duration of response), and PFS (progression free survival) according to Lugano criteria and iwCLL 2018 criteria; - OS (overall survival).
2. Characterize pharmacokinetics profile of AZD5492, by: - Determining PK parameters, including but not limited to Cmax (maximum observed concentration), AUC (Area under the curve), clearance and t½ (half-life). - Antibody serum concentration.
3. Determine the immunogenicity of AZD5492: the number and percentage of participants who develop ADA (Anti Drug Antibodies).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AstraZeneca AB

Sponsor organisation

AstraZeneca AB

Address

-

City

Sodertalje

Postcode

151 85

Country

Sweden

Scientific contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Public contact point

Organisation

AstraZeneca AB

Contact name

AstraZeneca Clinical Study Information Center

Locations

5 EU/EEA countries · 12 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 32 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications