Table of Contents
- Clinical trial overview
- Advanced solid tumors study
- Gastric and GEJ cancer study
- Non-small cell lung cancer study
- Classical Hodgkin lymphoma study
- Main endpoints and what they mean
- Who the trials are for
Clinical trial overview
The available studies of Sabestomig are testing it in different cancer groups, not in one single disease.[1][2][3][4] 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.[1][2][3][4]
Two studies were listed as Completed, and two were listed as Authorised.[1][2][3][4] This shows that Sabestomig has been studied in more than one cancer setting and that the research program is still active.[1][2][3][4]
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.[1] The study was completed and enrolled 232 participants.[1]
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.[1] 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.[1]
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.[2] It was authorised and planned for 341 participants.[2]
This study tests novel combinations, meaning Sabestomig is being studied with other treatment approaches, including chemotherapy-based regimens listed in the trial record.[2] The main goals are to measure objective response rate and progression-free survival at 6 months.[2] ORR shows how many patients have tumor shrinkage, and PFS6 shows how many are alive without the cancer getting worse after 6 months.[2]
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.[3] The trial was authorised and enrolled 232 participants.[3]
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.[3] 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.[3]
Classical Hodgkin lymphoma study
NCT05216835 is a Phase 1 study in patients with relapsed or refractory classical Hodgkin lymphoma.[4] It was completed and enrolled 190 participants.[4]
The study had a dose escalation part and a dose expansion part.[4] In the early part, the trial looked at safety, tolerability, dose-limiting toxicities, and dose selection.[4] 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.[4]
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.[4]
Main endpoints and what they mean
The main endpoints across the Sabestomig studies focus on safety first.[1][3][4] These include adverse events (side effects), serious adverse events, immune-mediated adverse events (side effects caused by the immune system), and dose-limiting toxicities.[1][3][4]
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.[1][3][4] 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.[2][4]
Who the trials are for
The trial populations are adults with serious cancers that are advanced, metastatic, unresectable, relapsed, or refractory.[1][2][3][4] 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.[1][2][3][4]
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.[1][2][3][4]
