Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sabestomig · 1 trial · 1 indication
The safety and tolerability of sabestomig in participants with r/r cHL were assessed.
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 2 or less within 3 days of getting maximal supportive care * ≥Grade 3 neutropenia, without fever or systemic infection, that does not improve by at least one grade within 7 days * Grade 4 thrombocytopenia for more than 7 days or ≥Grade 3 thrombocytopenia along with Grade ≥2 bleeding * Grade 4 Cytokine Release Syndrome (CRS) of any duration or Grade 3 CRS not improving to Grade ≤2 within 72 hours
The anti-tumor activity of sabestomig in participants with r/r cHL was planned to be assessed. ORR was defined as the percentage of participants with an objective response \[Best Overall Response of a complete response (CR) or partial response (PR)\] as per modified Lugano criteria (Lugano 2014), with the denominator defined as the number of participants in the response-evaluable analysis set. Disease response was planned to be assessed according to Blinded Independent Central Review using modified Lugano criteria (Lugano 2014).
The anti-tumor activity of sabestomig in participants with r/r cHL was planned to be assessed. The CRR was defined as the percentage of participants with a CR as per modified Lugano criteria (Lugano 2014), with the denominator defined as the number of participants in the response-evaluable analysis set. Disease response was planned to be assessed according to Blinded Independent Central Review using modified Lugano criteria (Lugano 2014).
The safety and tolerability of sabestomig in participants with r/r cHL was planned to be assessed.
| Arm | Type | Description |
|---|---|---|
| Cohort A: Dose Escalation | EXPERIMENTAL | Patients with anti-PD-1/PD-L1 exposed r/r cHL will receive sabestomig to determine the recommended phase 2 dose (RP2D). |
| Cohort B1: Dose Expansion | EXPERIMENTAL | Patients with anti-PD-1/PD-L1 exposed r/r cHL will receive sabestomig once the RP2D has been determined. |
| Cohort B2: Dose Expansion | EXPERIMENTAL | Patients with anti-PD-1/PD-L1 naïve r/r cHL will receive sabestomig once the RP2D has been determined. |
| Name | Type | Description |
|---|---|---|
| Sabestomig (AZD7789) | DRUG | Patients will receive sabestomig (PD-1/TIM-3 bispecific monoclonal antibody) via intravenous infusion. |
Inclusion Criteria: * ≥ 16 years of age at the time of obtaining informed consent * Eastern Cooperative Oncology Group performance status of 0 or 1 at screening * At least one positron emission tomography (PET)-avid measurable lesion according to Modified Lugano Criteria after the last line of ther...
Sabestomig is an investigational small molecule being studied for the treatment of relapsed or refractory classical Hodgkin lymphoma. It is intended for patients whose disease has not responded to prior therapy or has returned after treatment. The drug is currently in clinical development and has not been approved by regulatory authorities.
Sabestomig is a small molecule developed by AstraZeneca for oncology. Its specific molecular target has not been disclosed in the available information. The drug is being evaluated for its safety and preliminary efficacy in patients with relapsed or refractory classical Hodgkin lymphoma.
Sabestomig is being developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical research to evaluate the drug's potential in treating relapsed or refractory classical Hodgkin lymphoma.
Sabestomig is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. The Phase 1 trial has been completed, and the drug is still being studied to assess its safety and preliminary efficacy in patients with relapsed or refractory classical Hodgkin lymphoma.
Sabestomig has been studied in one clinical trial with the identifier NCT05216835. This Phase 1 trial, titled 'Safety and Preliminary Efficacy Assessment of AZD7789 in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma,' enrolled 45 participants across the United States, Canada, Denmark, France, Italy, Spain, and the United Kingdom. The trial has been completed.
Sabestomig is also known as AZD7789. The clinical trial NCT05216835, which evaluated the drug in patients with relapsed or refractory classical Hodgkin lymphoma, used the name AZD7789 in its title. Both names refer to the same investigational drug being developed by AstraZeneca.