NCT05216835

Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma

Completed Phase 1 Results posted Last updated 2 October 2025

What this trial tests

Phase 1 trial testing Sabestomig (AZD7789) in Relapsed or Refractory Classical Hodgkin Lymphoma in 45 participants. Completed in 4 September 2025.

Timeline

18 March 2022

Primary endpoint
30 August 2024

4 September 2025

Quick facts

Lead sponsor	AstraZeneca
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	45
Start date	18 March 2022
Primary completion	30 August 2024
Estimated completion	4 September 2025
Sites	14 locations across Denmark, France, Italy, United Kingdom, Canada, United States, Spain

Drugs / interventions tested

• Sabestomig (AZD7789) — full drug profile →

Conditions studied

• Relapsed or Refractory Classical Hodgkin Lymphoma — all drugs for Relapsed or Refractory Classical Hodgkin Lymphoma →

Sponsor

AstraZeneca — full company profile →

Who can join

Adults 16 to 101, any sex, with Relapsed or Refractory Classical Hodgkin Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Part A (Dose Escalation): Number of Participants With Adverse Events (AEs) Primary · From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)

The safety and tolerability of sabestomig in participants with r/r cHL were assessed.

Any AE

Group	Value	95% CI
Cohort A1	1
Cohort A2	1
Cohort A3	1
Cohort A4	1
Cohort A5	4
Cohort A6	12
Cohort A7	10
Cohort A8	12

Any AE possibly related to Sabestomig [a]

Group	Value	95% CI
Cohort A1	0
Cohort A2	1
Cohort A3	0
Cohort A4	1
Cohort A5	3
Cohort A6	10
Cohort A7	8
Cohort A8	6

Any AE of CTCAE grade 3 or higher

Group	Value	95% CI
Cohort A1	0
Cohort A2	0
Cohort A3	0
Cohort A4	0
Cohort A5	1
Cohort A6	4
Cohort A7	2
Cohort A8	2

Any AE of CTCAE grade 3 or higher, possibly related to Sabestomig [a]

Group	Value	95% CI
Cohort A1	0
Cohort A2	0
Cohort A3	0
Cohort A4	0
Cohort A5	0
Cohort A6	2
Cohort A7	1
Cohort A8	1

Any AE with outcome = death

Group	Value	95% CI
Cohort A1	0
Cohort A2	0
Cohort A3	0
Cohort A4	0
Cohort A5	1
Cohort A6	0
Cohort A7	0
Cohort A8	0

Any AE with outcome = death, possibly related to Sabestomig [a]

Group	Value	95% CI
Cohort A1	0
Cohort A2	0
Cohort A3	0
Cohort A4	0
Cohort A5	0
Cohort A6	0
Cohort A7	0
Cohort A8	0

Any SAE (including events with outcome = death)

Group	Value	95% CI
Cohort A1	0
Cohort A2	0
Cohort A3	0
Cohort A4	0
Cohort A5	3
Cohort A6	2
Cohort A7	2
Cohort A8	0

Any SAE (including events with outcome = death), possibly related to Sabestomig [a]

Group	Value	95% CI
Cohort A1	0
Cohort A2	0
Cohort A3	0
Cohort A4	0
Cohort A5	2
Cohort A6	2
Cohort A7	0
Cohort A8	0

Part A (Dose Escalation): Number of Participants With Adverse Events of Special Interest (AESIs) Secondary · From start of treatment [C1D1 (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months)

The safety and tolerability of sabestomig in participants with r/r cHL were assessed. An AESI was an AE of scientific and medical interest specific to understanding of a study intervention and may have required close monitoring and rapid communication to AstraZeneca by the Investigator. The AESIs for sabestomig include events with a potential inflammatory or immune-mediated mechanism and which may require more frequent monitoring and/or interventions such as steroids, immunosuppressants and/or hormone replacement therapy.

Group	Value	95% CI
Cohort A1	0
Cohort A2	1
Cohort A3	0
Cohort A4	1
Cohort A5	2
Cohort A6	8
Cohort A7	7
Cohort A8	5

Part A (Dose Escalation): Number of Participants With Dose-limiting Toxicities (DLTs) Primary · From first dose (C1D1) until 28 days for each participant [within 28 days DLT period]

DLT was defined as any ≥Grade 3 AE as per NCI CTCAE version 5 unless unequivocally due to underlying malignancy or an extraneous cause. The following conditions were considered as DLTs: * Any death not clearly due to the underlying disease or extraneous causes * Grade 4 imAE or anemia * Any ≥Grade 3 non-infectious pneumonitis or colitis of any duration * Specific liver transaminase elevation as per protocol * Any Grade 3 imAE, including rash, pruritus, or diarrhea, that does not downgrade to Grade 2 or less within 7 days * Grade 3 nausea, vomiting, or diarrhea that does not resolve to Grade

Group	Value	95% CI
Cohort A1	0
Cohort A2	0
Cohort A3	0
Cohort A4	0
Cohort A5	1
Cohort A6	0
Cohort A7	0
Cohort A8	0

Part A (Dose Escalation): Complete Response Rate (CRR) Secondary · From start of treatment [C1D1 (each cycle was 28 days)] until first documented disease progression, or last evaluable assessment in the absence of progression (up to 2 years 5 months)

The anti-tumor activity of sabestomig in participants with r/r cHL was assessed. The CRR was defined as the percentage of participants with a CR as per modified Lugano criteria (Lugano 2014) as assessed by the Investigator, with the denominator defined as the number of participants in the response-evaluable analysis set. Disease response was assessed according to Investigator assessment using modified Lugano criteria (Lugano 2014).

Group	Value	95% CI
Cohort A1	NA
Cohort A2	NA
Cohort A3	NA
Cohort A4	NA
Cohort A5	0
Cohort A6	33.3
Cohort A7	0
Cohort A8	0

Part A (Dose Escalation): Objective Response Rate (ORR) Secondary · From start of treatment [C1D1 (each cycle was 28 days)] until progression, or last evaluable assessment in the absence of progression (up to 2 years 5 months)

The anti-tumor activity of sabestomig in participants with r/r cHL was assessed. The ORR was defined as the percentage of participants with an objective response (Best Overall Response of CR or PR) as per modified Lugano criteria (Lugano 2014), as assessed by the Investigator, with the denominator defined as the number of participants in the response-evaluable analysis set. Disease response was assessed according to Investigator assessment using modified Lugano criteria (Lugano 2014).

Group	Value	95% CI
Cohort A1	NA	NA – NA
Cohort A2	NA	NA – NA
Cohort A3	NA	NA – NA
Cohort A4	NA	NA – NA
Cohort A5	0.0	NA – NA
Cohort A6	50.0	21.1 – 78.9
Cohort A7	25.0	5.5 – 57.2
Cohort A8	16.7	2.1 – 48.4

Part A (Dose Escalation): Duration of Response (DoR) Secondary · From first documented response until date of first documented disease progression or death from any cause, or data cut-off or end of study (whichever came first, assessed up to 2 years 5 months)

The anti-tumor activity of sabestomig in participants with r/r cHL was assessed. The DoR was defined as the time from the date of first documented objective response (CR or PR), as assessed by Investigator, using the modified Lugano criteria (Lugano 2014), until the date of first documented disease progression or death (by any cause in the absence of disease progression). Disease response was assessed according to Investigator assessment using modified Lugano criteria (Lugano 2014).

Group	Value	95% CI
Cohort A1	NA	NA – NA
Cohort A2	NA	NA – NA
Cohort A3	NA	NA – NA
Cohort A4	NA	NA – NA
Cohort A6	NA	2.7 – NA
Cohort A7	7.7	7.1 – NA
Cohort A8	6.3	NA – NA

Part A (Dose Escalation): Duration of Complete Response (DoCR) Secondary · From first documented complete response until date of first documented disease progression or death from any cause, or data cut-off or end of study (whichever came first, assessed up to 2 years 5 months)

The anti-tumor activity of sabestomig in participants with r/r cHL was assessed. The DoCR was defined as the time from first documented CR, as per modified Lugano criteria (Lugano 2014) as assessed by the Investigator, until the date of first documented relapse/progression or death due to any cause (in the absence of disease progression). Disease response was assessed according to Investigator assessment using modified Lugano criteria (Lugano 2014).

Group	Value	95% CI
Cohort A6	NA	NA – NA

Part A (Dose Escalation): Progression-free Survival (PFS) Secondary · From start of treatment [C1D1 (each cycle was 28 days)] until date of first documented disease progression or data cut-off or end of study (whichever came first, assessed up to 2 years 5 months)

The anti-tumor activity of sabestomig in participants with r/r cHL was assessed. PFS was defined as the time from first dose until the earlier of the date of first documented disease progression, as per modified Lugano criteria (Lugano 2014) as assessed by the Investigator, or death (by any cause in the absence of disease progression or subsequent anticancer treatment). Disease response was assessed according to Investigator assessment using modified Lugano criteria (Lugano 2014).

Group	Value	95% CI
Cohort A1	NA	NA – NA
Cohort A2	NA	NA – NA
Cohort A3	NA	NA – NA
Cohort A4	NA	NA – NA
Cohort A5	1.9	1.4 – NA
Cohort A6	4.8	2.4 – 11.9
Cohort A7	5.7	1.8 – NA
Cohort A8	2.1	1.6 – 8.1

Part A (Dose Escalation): Overall Survival (OS) Secondary · From start of treatment [C1D1 (each cycle was 28 days)] until date of death due to any cause or data cut-off or end of study (whichever came first, assessed up to 2 years 5 months)

The anti-tumor activity of sabestomig in participants with r/r cHL was assessed. The OS was defined as the time from the start of treatment until death due to any cause regardless of whether participant withdraws from treatment or receives another anti-lymphoma therapy.

Group	Value	95% CI
Cohort A1	NA	NA – NA
Cohort A2	NA	NA – NA
Cohort A3	NA	NA – NA
Cohort A4	NA	NA – NA
Cohort A5	NA	1.4 – NA
Cohort A6	NA	NA – NA
Cohort A7	NA	NA – NA
Cohort A8	NA	8.4 – NA

Part A (Dose Escalation): Number of Participants With Positive Anti-drug Antibodies (ADA) Against Sabestomig in Serum Secondary · On C1D1, C2D1, and until end of study [up to 2 years 5 months (each cycle was 28 days)]

The presence of ADA for sabestomig in treated participants with r/r cHL was assessed.

ADA prevalence

Group	Value	95% CI
Cohort A1	1
Cohort A2	0
Cohort A3	0
Cohort A4	0
Cohort A5	3
Cohort A6	4
Cohort A7	4
Cohort A8	2

Treatment-induced ADA positive

Group	Value	95% CI
Cohort A1	1
Cohort A2	0
Cohort A3	0
Cohort A4	0
Cohort A5	3
Cohort A6	4
Cohort A7	3
Cohort A8	2

Treatment-boosted ADA

Group	Value	95% CI
Cohort A1	1
Cohort A2	0
Cohort A3	0
Cohort A4	0
Cohort A5	3
Cohort A6	3
Cohort A7	4
Cohort A8	2

ADA incidence

Group	Value	95% CI
Cohort A1	1
Cohort A2	0
Cohort A3	0
Cohort A4	0
Cohort A5	3
Cohort A6	4
Cohort A7	4
Cohort A8	2

ADA positive at baseline and at least one post-baseline

Group	Value	95% CI
Cohort A1	0
Cohort A2	0
Cohort A3	0
Cohort A4	0
Cohort A5	0
Cohort A6	0
Cohort A7	1
Cohort A8	0

ADA positive at baseline and not positive at post-baseline

Group	Value	95% CI
Cohort A1	0
Cohort A2	0
Cohort A3	0
Cohort A4	0
Cohort A5	0
Cohort A6	0
Cohort A7	0
Cohort A8	0

ADA transient positive

Group	Value	95% CI
Cohort A1	0
Cohort A2	0
Cohort A3	0
Cohort A4	0
Cohort A5	1
Cohort A6	2
Cohort A7	2
Cohort A8	0

ADA persistently positive

Group	Value	95% CI
Cohort A1	1
Cohort A2	0
Cohort A3	0
Cohort A4	0
Cohort A5	2
Cohort A6	2
Cohort A7	1
Cohort A8	2

Part A (Dose Escalation): Maximum Observed Concentration (Cmax) Secondary · From C1D1 [before start of infusion (SOI) and at end of infusion (EOI)] to end of study [up to 2 years 5 months (each cycle was 28 days)]

The Cmax of sabestomig in participants with r/r cHL was assessed.

Group	Value	95% CI
Cohort A1	NA	0.14 – 0.14
Cohort A2	NA	1.41 – 1.41
Cohort A3	NA	5.80 – 5.80
Cohort A4	NA	15.40 – 15.40
Cohort A5	52.49	39.60 – 82.90
Cohort A6	256.00	172.00 – 430.00
Cohort A7	516.00	364.00 – 1480.00
Cohort A8	695.10	323.00 – 1400.00

Part A (Dose Escalation): Area Under the Concentration-time Curve (AUC) Secondary · From C1D1 (before SOI and at EOI) to end of study [up to 2 years 5 months (each cycle was 28 days)]

The AUC of sabestomig in participants with r/r cHL was assessed.

Group	Value	95% CI
Cohort A2	NA	4.24 – 4.24
Cohort A3	NA	28.50 – 28.50
Cohort A4	NA	88.80 – 88.80
Cohort A5	273.00	110.00 – 518.00
Cohort A6	2256.00	1710.00 – 4780.00
Cohort A7	4687.00	2740.00 – 8370.00
Cohort A8	6883.00	2560.00 – 8120.00

Adverse events — posted to ClinicalTrials.gov

Time frame: From start of treatment [Cycle 1 Day 1 (C1D1) (each cycle was 28 days)] up to 90 days post last dose (approximately 2 years 5 months). Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort A1

Serious: 0/1 (0%)

Deaths: 0/1

Cohort A2

Serious: 0/1 (0%)

Deaths: 0/1

Cohort A3

Serious: 0/1 (0%)

Deaths: 0/1

Cohort A4

Serious: 0/1 (0%)

Deaths: 1/1

Cohort A5

Serious: 3/5 (60%)

Deaths: 1/5

Cohort A6

Serious: 3/12 (25%)

Deaths: 1/12

Cohort A7

Serious: 4/12 (33%)

Deaths: 1/12

Cohort A8

Serious: 2/12 (17%)

Deaths: 1/12

Serious adverse events (14 terms)

Reaction	System	Cohort A1	Cohort A2	Cohort A3	Cohort A4	Cohort A5	Cohort A6	Cohort A7	Cohort A8
Herpes zoster	Infections and infestations	—	—	—	—	—	—	—	—
Ophthalmic herpes zoster	Infections and infestations	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Cytokine release syndrome	Immune system disorders	—	—	—	—	—	—	—	—
Post herpetic neuralgia	Nervous system disorders	—	—	—	—	—	—	—	—
Gastric perforation	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Cholecystitis acute	Hepatobiliary disorders	—	—	—	—	—	—	—	—
Exertional rhabdomyolysis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Acute kidney injury	Renal and urinary disorders	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—
Infusion related reaction	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—

Other adverse events (130 terms — click to expand)

Reaction	System	Cohort A1	Cohort A2	Cohort A3	Cohort A4	Cohort A5	Cohort A6	Cohort A7	Cohort A8
COVID-19	Infections and infestations	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—
Infusion related reaction	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—
Herpes zoster	Infections and infestations	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—
Rhinitis	Infections and infestations	—	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—
Lipase increased	Investigations	—	—	—	—	—	—	—	—
Cystitis	Infections and infestations	—	—	—	—	—	—	—	—
Device related infection	Infections and infestations	—	—	—	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—	—	—	—
Infected dermal cyst	Infections and infestations	—	—	—	—	—	—	—	—
Influenza	Infections and infestations	—	—	—	—	—	—	—	—
Otitis externa	Infections and infestations	—	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—	—
Respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—	—	—
Skin infection	Infections and infestations	—	—	—	—	—	—	—	—
Tooth abscess	Infections and infestations	—	—	—	—	—	—	—	—
Tracheitis	Infections and infestations	—	—	—	—	—	—	—	—
Lymphopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—	—	—	—
Acute graft versus host disease in skin	Immune system disorders	—	—	—	—	—	—	—	—
Seasonal allergy	Immune system disorders	—	—	—	—	—	—	—	—
Autoimmune thyroiditis	Endocrine disorders	—	—	—	—	—	—	—	—

Most-reported serious reactions: Herpes zoster, Ophthalmic herpes zoster, Pneumonia, Sepsis, Urinary tract infection, Febrile neutropenia, Cytokine release syndrome, Post herpetic neuralgia.

Data from ClinicalTrials.gov NCT05216835 adverse events section.

Sponsor's own description

The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of sabestomig (AZD7789) in patients with relapsed/refractory classical Hodgkin Lymphoma (r/r cHL).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Targeting LAG-3, TIM-3, and TIGIT for cancer immunotherapy.
   Cai L, Li Y, Tan J, Xu L, et al · · 2023 · cited 232× · PMID 37670328 · DOI 10.1186/s13045-023-01499-1
2. Current landscape and future directions of bispecific antibodies in cancer immunotherapy.
   Wei J, Yang Y, Wang G, Liu M. · · 2022 · cited 127× · PMID 36389699 · DOI 10.3389/fimmu.2022.1035276
3. TIM-3 as a promising target for cancer immunotherapy in a wide range of tumors.
   Sauer N, Janicka N, Szlasa W, Skinderowicz B, et al · · 2023 · cited 89× · PMID 37567938 · DOI 10.1007/s00262-023-03516-1
4. Spatially Resolved Tumor Microenvironment Predicts Treatment Outcomes in Relapsed/Refractory Hodgkin Lymphoma.
   Aoki T, Jiang A, Xu A, Yin Y, et al · · 2024 · cited 37× · PMID 38113419 · DOI 10.1200/jco.23.01115
5. Antibody-based cancer immunotherapy by targeting regulatory T cells.
   Li Q, Lu J, Li J, Zhang B, et al · · 2023 · cited 25× · PMID 37182149 · DOI 10.3389/fonc.2023.1157345
6. Bispecific Antibodies in Cancer Immunotherapy: A Novel Response to an Old Question.
   Ordóñez-Reyes C, Garcia-Robledo JE, Chamorro DF, Mosquera A, et al · · 2022 · cited 22× · PMID 35745815 · DOI 10.3390/pharmaceutics14061243
7. TIM-3 teams up with PD-1 in cancer immunotherapy: mechanisms and perspectives.
   Yan Z, Wang C, Wu J, Wang J, et al · · 2025 · cited 21× · PMID 40332725 · DOI 10.1186/s43556-025-00267-6
8. Advances and clinical applications of immune checkpoint inhibitors in hematological malignancies.
   Sun W, Hu S, Wang X. · · 2024 · cited 19× · PMID 39073258 · DOI 10.1002/cac2.12587