BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), an Israel-based pre-commercial-stage biopharmaceutical company, announced on Tuesday its outcome from the Phase 1/2a study of intratumoral cancer vaccine candidate, AGI-134, aimed at assessing the safety and biological activity of AGI-134 in subjects with unresectable metastatic solid tumours.
The study met its primary endpoint of AGI-134's safety and tolerability. In this first-in-human trial, a total of 38 patients were treated with AGI-134: 5 patients in part 1, the accelerated dose-escalation part of the study; and 33 patients in part 2, the dose expansion part of the study. Part 1 demonstrated that AGI-134 was safe and well tolerated, with no dose-limiting toxicities reported. The maximum tolerated dose was not reached and the recommended dose for part 2 of the study (RP2D) was determined to be up to 200mg. In the dose expansion part 2 of the study, AGI-134 was generally well-tolerated, with treatment-related adverse events being transient and mostly mild to moderate.
The Phase 1/2a clinical trial, a multicentre, open-label study, recruited a total of 38 subjects in the UK, Spain and Israel.
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