A trial to learn how well surovatamig (AZD0486) works and how safe it is in adults with certain 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

14 Apr 2025 → ongoing

Decision date (initial)

2025-02-19

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AstraZeneca AB

External identifiers

EU CT number

2023-505789-27-00

ClinicalTrials.gov

NCT06526793

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacogenetic, Safety, Pharmacodynamic, Therapy, Pharmacogenomic, Pharmacokinetic

To evaluate the efficacy of surovatamig (AZD0486) single therapy administered at the Recommended Phase 2 Dose (RP2D) in relapsed or refractory B-cell NHL

Secondary objectives 9

1. 1. To assess the safety and tolerability of surovatamig
2. 2.To further evaluate the efficacy of surovatamig by assessment of DoR and CR rate
3. 3. To evaluate ORR and CR rate
4. 4. To evaluate the efficacy of surovatamig by evaluation of additional efficacy measures based on Lugano 2014 Response Criteria
5. 5. To characterize the PK of surovatamig
6. 6. To describe the incidence of immunogenicity
7. 7. To evaluate patient-reported tolerability of surovatamig, including severity of key treatment-related symptoms and overall side-effect burden
8. 8. To evaluate patient-reported severity of key disease-related symptoms, as well as the impact of disease on lymphoma-specific concerns and general HRQoL, while on surovatamig
9. 9.Evaluate the impact of surovatamig on MRD-negative CR rate

Conditions and MedDRA coding

Relapsed or Refractory Non-Hodgkin Lymphoma

Study design 2 periods

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration, European Medicines Agency

Plan to share IPD

Yes

IPD plan description

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 shared. AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment https://vivli.org/. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. 1. Participant must be 18 years old and above at the time of signing the ICF.
2. 2. ECOG performance status of 0 to 2
3. 3. Relapsed or refractory disease after at least 2 prior lines of systemic therapy
4. 4. Histologically confirmed diagnosis of B-NHL, based on local pathology report, as determined by WHO 2022 classification
5. 5. FDG-avid and measurable disease
6. 6. Adequate liver, hematological, renal and cardiac function.
7. The above is a summary, other inclusion criteria details may apply

Exclusion criteria 7

1. 1. Diagnosis of chronic lymphocytic leukemia, Burkitt lymphoma, or Richter’s transformation
2. 2. Active CNS involvement by B-NHL.
3. 3. Leukemic presentation of disease
4. 4. Prior neurotoxicity/ICANS or CRS
5. 5. History or presence of clinically relevant CNS pathology (based on investigator assessment)
6. 6. Prior allogeneic HSCT or solid organ transplantation within 24 weeks of first planned dose of surovatamig
7. The above is a summary, other exclusion criteria details may apply

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. ORR, defined as the proportion of participants achieving either a PR or CR based on Lugano 2014 Response Criteria as determined by an IRC

Secondary endpoints 7

1. 1. Safety and tolerability of surovatamig - incidence, nature, and severity of AEs/SAEs/AESI, changes in laboratory data, vital signs, and ECGs compared with baseline, incidence and nature of study drug discontinuation, dose reduction, and dose delay due to AEs
2. 2. Efficacy - DoR and CR, ORR and CR rates
3. 3. Efficacy - DoCR, TTR, EFS, PFS, TTNT, OS
4. 4. PK - PK parameters such as such as Cmax, Tmax, Ctrough of surovatamig (at predefined intervals)
5. 5. Immunogenicity -pre-existing and induced ADA for surovatamig
6. 6. PROs - difference in severity levels in fatigue, pain, cognition and overall side-effect burden
7. 7. MRD-negative CR rate

Investigational products

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

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Astrazeneca AB

Sponsor organisation

Astrazeneca AB

Address

Astraallen Gartuna, Karlebyhus Byggnad 674 Karlebyhus Byggnad 674

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

6 EU/EEA countries · 22 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 64 files

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

Application history

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