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DRUG:

sabestomig (AZD7789)

i
Other names: AZD7789, AZD 7789, AZD-7789
Associations
Company:
AstraZeneca
Drug class:
PD1 inhibitor, TIM-3 inhibitor
Related drugs:
Associations
3ms
Trial completion date
|
sabestomig (AZD7789)
5ms
D9571C00001: Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (clinicaltrials.gov)
P1/2, N=45, Active, not recruiting, AstraZeneca | Trial completion date: Oct 2027 --> Dec 2024 | Trial primary completion date: Feb 2026 --> Aug 2024
Trial completion date • Trial primary completion date
|
sabestomig (AZD7789)
6ms
A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer (clinicaltrials.gov)
P1/2, N=232, Recruiting, AstraZeneca | Trial completion date: Jul 2025 --> Aug 2026 | Trial primary completion date: Jul 2025 --> Aug 2026
Trial completion date • Trial primary completion date • Metastases
|
sabestomig (AZD7789)
7ms
Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (clinicaltrials.gov)
P1/2, N=45, Active, not recruiting, AstraZeneca | Recruiting --> Active, not recruiting | N=180 --> 45 | Trial primary completion date: Aug 2026 --> Feb 2026
Enrollment closed • Enrollment change • Trial primary completion date
|
sabestomig (AZD7789)
8ms
Enrollment open
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Keytruda (pembrolizumab) • rilvegostomig (AZD2936) • volrustomig (MEDI5752) • sabestomig (AZD7789)
8ms
New P1 trial
|
Keytruda (pembrolizumab) • rilvegostomig (AZD2936) • volrustomig (MEDI5752) • sabestomig (AZD7789)
9ms
A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer (clinicaltrials.gov)
P1/2, N=232, Recruiting, AstraZeneca | Trial completion date: Apr 2025 --> Jul 2025 | Trial primary completion date: Jan 2025 --> Jul 2025
Trial completion date • Trial primary completion date • Metastases
|
PD-L1 expression
|
sabestomig (AZD7789)
11ms
Enrollment change • Metastases
|
PD-L1 expression
|
sabestomig (AZD7789)
12ms
Combination therapy • Enrollment change • Phase classification • Metastases
|
EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase)
|
PD-L1 expression
|
PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay • PD-L1 IHC 28-8 pharmDx
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carboplatin • Imfinzi (durvalumab) • datopotamab deruxtecan (DS-1062a) • rilvegostomig (AZD2936) • volrustomig (MEDI5752) • sabestomig (AZD7789)
1year
Enrollment change • Metastases
|
CLDN18 (Claudin 18)
|
5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • sonesitatug vedotin (AZD0901) • rilvegostomig (AZD2936) • volrustomig (MEDI5752) • sabestomig (AZD7789)
1year
Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (clinicaltrials.gov)
P1/2, N=180, Recruiting, AstraZeneca | Trial completion date: Feb 2026 --> Oct 2027 | Trial primary completion date: Oct 2025 --> Aug 2026
Trial completion date • Trial primary completion date
|
sabestomig (AZD7789)
1year
Safety and Preliminary Efficacy of Sabestomig (AZD7789), an Anti-PD-1 and Anti-TIM-3 Bispecific Antibody, in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma Previously Treated with Anti-PD-(L)1 Therapy (ASH 2023)
Sabestomig is intravenously infused over 1 hour following pretreatment with diphenhydramine and acetaminophen every 3 weeks, with planned doses ranging from 2 to 2000 mg across 8 cohorts (A1–A8); cohorts A1 to A4 (2, 7, 22.5 or 75 mg) follow an accelerated titration design with a single patient treated at each dose level, while cohorts A5 to A8 (225–2000 mg) follow a modified toxicity probability interval-2 algorithm. Early efficacy data at 750 mg is encouraging with objective responses in 3/3 patients who had their first disease assessment, including those who were anti-PD-1 refractory or who relapsed on treatment. Updated data will be presented from ongoing and subsequent patients treated during dose escalation with doses of up to 2000 mg.
Clinical • PD(L)-1 Biomarker • IO biomarker
|
HAVCR2 (Hepatitis A Virus Cellular Receptor 2)
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HAVCR2 expression
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sabestomig (AZD7789)
over1year
Safety and preliminary efficacy of AZD7789, a bispecific antibody targeting PD-1 and TIM-3, in patients (pts) with stage IIIB–IV non-small-cell lung cancer (NSCLC) with previous anti-PD-(L)1 therapy (ESMO 2023)
Conclusions AZD7789 has manageable safety and shows preliminary efficacy at tolerable doses. Evaluation is ongoing in immunotherapy-naive pts with NSCLC and pts with acquired resistance to immunotherapy.
Clinical
|
HAVCR2 (Hepatitis A Virus Cellular Receptor 2)
|
sabestomig (AZD7789)
over1year
Enrollment change • Metastases
|
PD-L1 expression
|
sabestomig (AZD7789)
over1year
Trial completion date
|
sabestomig (AZD7789)
over1year
Trial primary completion date
|
sabestomig (AZD7789)
2years
Generation of AZD7789, a novel PD-1 and TIM-3 targeting bispecific antibody, which binds to a differentiated epitope of TIM-3 (SITC 2022)
AZD7789 is being tested in IO pretreated patients with NSCLC ( NCT04931654 ) and cHL ( NCT05216835 ). Trial Registration NCT04931654; NCT05216835
PD(L)-1 Biomarker • IO biomarker
|
IFNG (Interferon, gamma) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2)
|
HAVCR2 expression
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sabestomig (AZD7789)