Study of Intralesional Administration of MK-4621 (RGT100) in Adult Participants With Advanced or Recurrent Tumors (MK-4621-001/RGT100-001)

Phase 1/2 Terminated 15 enrolled Merck Sharp & Dohme LLC

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase I/II multicenter, first-in-human open-label, dose escalation study to evaluate the safety, tolerability, and anti-tumor activity of intratumoral (IT)/intralesional (IL) injections of MK-4621 (RGT100) in adult participants with selected advanced or recurrent tumors.

Timeline

Start: 2017-04-25
Primary completion: 2018-05-18
Completion: 2018-05-18

Outcome

Outcome not reported

Stopped (Business): “Group B not started for business reasons.”

Publications

Moreno V, Calvo E, Middleton MR, Barlesi F, Gaudy-Marqueste C, Italiano A, Romano E, Marabelle A, Chartash E, Dobrenkov K, Zhou H, Connors EC, Zhang Y, Wermke M. Treatment with a retinoic acid-inducible gene I (RIG-I) agonist as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors: results from two phase 1 studies. Cancer Immunol Immunother. 2022 Dec;71(12):2985-2998. doi: 10.1007/s00262-022-03191-8. Epub 2022 May 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MK-4621	Oligonucleotide (other)	0.2 mg	Other
Subject	MK-4621	Oligonucleotide (other)	0.8 mg	Other