On April 1, 2022 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported the completion of the patient enrollment for the 600 mg dose cohort from Alligator’s Phase I, first-in-human clinical trial with the 4-1BB (CD137) targeting drug candidate, ATOR-1017, which is being developed as a tumor-directed therapy for advanced/metastatic cancer (Press release, Alligator Bioscience, APR 1, 2022, https://alligatorbioscience.se/en/alligator-bioscience-announces-completion-of-600-mg-dose-cohort-for-ator-1017-dose-escalation-and-enrollment-for-900-mg-dose-cohort-commences/ [SID1234611338]). The Phase I study with ATOR-1017 is an open-label, dose escalation study in patients with histologically confirmed, advanced and/or refractory solid cancer (NCT04144842). The primary objective of the study is to investigate the safety and tolerability of ATOR-1017, and to determine the recommended dose for subsequent Phase II studies.

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The data indicate that for doses up to 600 mg, there were no significant safety concerns with stable disease as the best tumor response. Patient enrollment and treatment for the highest planned dose cohort, 900 mg, has commenced.

As previously announced in December 2021, results from the early readout for ATOR-1017 showed that the drug candidate has an encouraging safety profile. In this readout, there was no dose-limiting toxicity or severe immune-related adverse events (link to press release).