RayzeBio has completed participant enrolment in the Phase Ib portion of the Phase Ib/III ACTION-1 trial of RYZ101 (Actinium-225 DOTATATE) in SSTR+ gastroenteropancreatic neuroendocrine tumour (GEP-NETs) patients, who have progressed on Lutetium-177 labelled somatostatin analogue therapy.
The Phase 1b clinical trial has been designed to assess the tolerability, pharmacokinetics, and safety of RYZ101.
This dose de-escalation trial has enrolled a total of 17 participants who received the highest recommended dose.
All these participants have crossed the required eight-week dose limiting toxicity (DLT) period, with no DLTs observed.
In the trial, participants will receive up to four RYZ101 doses at eight-week intervals.
RayzeBio chief medical officer Susan Moran said: “We are thankful to the patients that enrolled in this important study. The interest and enthusiasm is evident based on the over enrolment in Phase Ib.
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“We look forward to reporting safety and preliminary efficacy results from the trial later this year and moving into a Phase III registrational study.
“RYZ101 is backed by a strong scientific rationale and has the potential to play a significant role in the treatment of patients with GEP-NETs.”
The company expects to release the preliminary efficacy and safety data from the trial during this year.
The targeted radiopharmaceutical therapy RYZ101 has been designed for delivering Actinium-225 (Ac225), a highly potent radioisotope, to SSTR2-expressing tumours.
It is currently being assessed in clinical trials to treat SSTR+ GEP-NETs patients, who have previously received treatment with Lu177-based somatostatin therapies as well as extensive stage small cell lung cancer patients.