drugset / Trial / NCT04672980

RTX-321 Monotherapy in Patients With HPV 16+ Tumors

NCT04672980 ↗

Phase 1 Terminated 9 enrolled Rubius Therapeutics
Non-randomizedSequentialOpen-labelTreatment

Summary

This is an open-label, multicenter, multiple-ascending dose, FIH, Phase 1 study of RTX-321 for the treatment of patients that are HLA-A\*02:01 positive with persistent, recurrent, or metastatic, unresectable, HPV 16+ cancers.

Timeline

Start
2021-04-08
Primary completion
2022-11-30
Completion
2022-11-30

Outcome

Outcome not reported

Stopped: “The Sponsor terminated study after dosing 3 dose groups (9 pts) and closed trial on 11/30/22. RTX-321 was well-tolerated with no DLTs, no related deaths, SAEs or Gr. 3/4 AEs and cleared from circulation rapidly (w/in 10 min).”

Drugs

EvaluationDrugModalityDoseRoute
Subject RTX-321 Cell therapy — Intravenous