Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Sabestomig
AZD7789 · 2 trials · 4 indications
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.
Number of participants with AEs, SAEs, imAEs including AEs leading to discontinuation of study intervention and clinically significant alterations in vital signs, laboratory parameters and ECG results
A DLT is a toxicity defined by the study protocol that occurs from the first dose of study intervention up to the end of the DLT evaluation period that is assessed as clearly unrelated to the primary disease or intercurrent illness.
Objective response rate as defined by RECIST v1.1
| 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. |
| Dose Escalation Part A: NSCLC Immuno-oncology (IO) acquired or primary resistance | EXPERIMENTAL | AZD7789 monotherapy |
| Dose Expansion Part B1: NSCLC IO acquired resistance - RP2D level 1 | EXPERIMENTAL | AZD7789 Monotherapy |
| Dose Expansion Part B2: NSCLC IO naive, PD-L1 50% or greater - RP2D level 1 | EXPERIMENTAL | AZD7789 Monotherapy |
| Dose Expansion Part B3: NSCLC IO acquired resistance - RP2D level 2 | EXPERIMENTAL | AZD7789 Monotherapy |
| Dose Expansion Part B4: advanced or metastatic gastric and GEJC IO acquired resistance- RP2D level 1 | EXPERIMENTAL | AZD7789 monotherapy |
| Dose Expansion Part B5: NSCLC IO naive, PD-L1 1-49% - RP2D Level 1 | EXPERIMENTAL | AZD7789 monotherapy |
| Name | Type | Description |
|---|---|---|
| Sabestomig (AZD7789) | DRUG | Patients will receive sabestomig (PD-1/TIM-3 bispecific monoclonal antibody) via intravenous infusion. |
| AZD7789 | DRUG | anti-PD-1 and anti-TIM-3 bispecific antibody |
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...
AZD7789 is an investigational small molecule being studied for the treatment of advanced or metastatic solid cancers, including non-small-cell lung carcinoma, gastric cancer, and gastroesophageal junction cancer. It is in Phase 1 clinical development and has not been approved for any indication.
AZD7789 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca is the sponsor of the Phase 1 clinical trial evaluating the drug in patients with advanced or metastatic solid cancers.
AZD7789 is in Phase 1 clinical development. The single registered trial, NCT04931654, is a Phase 1 study that is currently active but not recruiting. The drug remains investigational and has not received FDA approval.
AZD7789 is being evaluated in one clinical trial, NCT04931654, titled "A Study to Assess the Safety and Efficacy of AZD7789 in Participants With Advanced or Metastatic Solid Cancer." The trial is active but not recruiting, with an enrollment of 136 participants across the United States, Canada, China, France, Georgia, Japan, Moldova, Netherlands, Spain, and Turkey.
Yes, the AZD7789 Phase 1 trial NCT04931654 is biomarker-selected, meaning participants are enrolled based on specific biomarker criteria. The study is randomized and controlled, evaluating the drug in adults with advanced or metastatic solid cancers including non-small-cell lung carcinoma, gastric cancer, and gastroesophageal junction cancer.