In short
Clinical trials are investigating Sabestomig in several cancer settings, including advanced solid tumors, gastric or gastroesophageal junction cancer, non-small cell lung cancer, and classical Hodgkin lymphoma. These studies mainly look at safety, tolerability, and early signs of benefit in different patient groups and trial phases.
Key points
- Sabestomig is being studied in clinical trials for several cancers, including advanced solid tumors, gastric or gastroesophageal junction cancer, non-small cell lung cancer, and relapsed or refractory classical Hodgkin lymphoma. The studies include Phase 1, Phase 1/2, and Phase 2 designs. Most early trials focus on safety, tolerability, dose finding, and side effects. Later trials also look at early signs of benefit, such as tumor response and progression-free survival. The target groups include people with advanced, metastatic, locally advanced unresectable, or relapsed/refractory disease.
Clinical trial overview
The available studies of Sabestomig are testing it in different cancer groups, not in one single disease. The trials include Phase 1, Phase 1/2, and Phase 2 research, which means some studies are focused first on safety and dose finding, while others also look for early signs that the treatment may help the cancer.
Two studies were listed as Completed, and two were listed as Authorised. This shows that Sabestomig has been studied in more than one cancer setting and that the research program is still active.
Advanced solid tumors study
NCT04931654 is a Phase 1/2 study in people with advanced or metastatic solid cancer, including gastric and gastroesophageal junction adenocarcinoma, non-small cell lung carcinoma, and other solid tumors. The study was completed and enrolled 232 participants.
The first part of the study, called dose escalation, was designed to find a safe and useful dose by watching for dose-limiting toxicities, the maximum tolerated dose, the optimal biological dose, and the recommended Phase 2 dose. The second part, called dose expansion, looked at safety and early antitumor activity, which means whether the cancer may start to shrink or stop growing.
Gastric and GEJ cancer study
NCT05702229 is a Phase 2 master protocol in people with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma. It was authorised and planned for 341 participants.
This study tests novel combinations, meaning Sabestomig is being studied with other treatment approaches, including chemotherapy-based regimens listed in the trial record. The main goals are to measure objective response rate and progression-free survival at 6 months. ORR shows how many patients have tumor shrinkage, and PFS6 shows how many are alive without the cancer getting worse after 6 months.
Non-small cell lung cancer study
2023-505992-54-00 is a Phase 1 study in people with advanced or metastatic non-small cell lung cancer. The trial was authorised and enrolled 232 participants.
This study focuses on the safety and tolerability of combination treatment, including Sabestomig in the trial record, with immunotherapy and, in some participants, up to 4 cycles of carboplatin. The main measures include dose-limiting toxicities, treatment-emergent adverse events, serious adverse events, and other safety checks such as vital signs, lab tests, ECG, heart scans, and eye exams.
Classical Hodgkin lymphoma study
NCT05216835 is a Phase 1 study in patients with relapsed or refractory classical Hodgkin lymphoma. It was completed and enrolled 190 participants.
The study had a dose escalation part and a dose expansion part. In the early part, the trial looked at safety, tolerability, dose-limiting toxicities, and dose selection. In the expansion part, the study looked at early antitumor activity, including objective response rate in one group and complete response rate in another group.
The trial record also notes different groups based on prior anti-PD-1/PD-L1 treatment exposure, which means some participants had already received similar immune-based treatment and others had not.
Main endpoints and what they mean
The main endpoints across the Sabestomig studies focus on safety first. These include adverse events (side effects), serious adverse events, immune-mediated adverse events (side effects caused by the immune system), and dose-limiting toxicities.
Several studies also check for changes in vital signs, laboratory tests, ECG results, and other clinical tests, because these help show whether the treatment is being tolerated safely. For efficacy, the studies measure endpoints such as ORR, complete response rate, and PFS6, which are simple ways to see whether the cancer is responding to treatment.
Who the trials are for
The trial populations are adults with serious cancers that are advanced, metastatic, unresectable, relapsed, or refractory. In simple terms, these are cancers that have spread, cannot be removed with surgery, have come back after treatment, or have not responded well to previous treatment.
The studies are not all in the same disease, so the target group depends on the trial: some are for solid tumors in general, some are for gastric or GEJ cancer, some are for NSCLC, and one is for classical Hodgkin lymphoma.