This bodes well for CHM 2101 safety profile.
- The second DMC review recommends the continuation of dose escalation in the clinical trial as per protocol.
- The interim safety assessment was based on the review of safety data from 18 metastatic gastrointestinal cancer patients, including patients that have tolerated multiple doses of cabotamig.
- The DMC review confirms the safety risk profile of cabotamig being consistent with published T-cell engagers.
SEATTLE,April 26, 2024/PRNewswire/ -- Arbele, a clinical-stage biotechnology company focused on the development of novel immunotherapies targeted for advanced gastrointestinal cancers, today announced the positive recommendation from the second meeting of the Data Monitoring Committee (DMC) to continue the A001 Phase I clinical trial evaluating cabotamig (ARB202) in patients with advanced gastrointestinal (GI) cancers without modification to the trial protocol. The DMC, composed of a group of independent experts, arrived at this recommendation after review of the interim safety data of patients enrolled in the A001 trial.
This safety assessment was based on the review of safety data from 18 patients, including patients that have been treated with multiple doses of cabotamig. This positive recommendation confirms tolerability profile of cabotamig is consistent with published safety data of T-cells engagers in other indications.
"We are greatly indebted to the courageous subjects who have participated in this early study of cabotamig that have allowed us better understand the safety profile while optimizing the dosing of this promising therapy" said DrDennis Wong, Chief Medical Officer at Arbele.
This study is phase 1 only. The study started 30/5/2022 and is estimated to be completed 8/2025.
This why we are extremely lucky to have the management we have, experience around trial design and knowledge in the field is invaluable.
Our phase 1/2 study is estimated to start midway through this year and estimated to be completed 6/2026. We will be years ahead of this other trial if successful. First to market big carrot for big pharma.
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