Health Trials

About this trial

This is an open label, multicenter, phase 1/2 study to assess the safety/tolerability and preliminary clinical activity of STAR0602 as a single agent administered intravenously in participants with advanced solid tumors that are antigen-rich.

Eligibility criteria

Qualifiers

Participants must have histologically confirmed solid tumors that are unresectable, locally advanced, or metastatic and for which standard curative therapies do not exist or are no longer effective or have intolerable toxicities. Subjects should not have received more than three lines of prior therapies for their advanced or metastatic diseases.

High mutational burden (TMB-H)

Microsatellite Instability (MSI-H)/DNA mismatch repair (dMMR)

Virally associated tumors

Disqualifiers

Vitiligo;

Psoriasis, atopic dermatitis or other autoimmune skin condition not requiring systemic treatment;

History of Graves' disease, now euthyroid for > 4 weeks;

Hypothyroidism managed by thyroid replacement;

Trial design

Treatments tested in this trial

  • STAR0602

Treatment groups

365 Participants
are divided into 2 treatment groups

Locations

32
Canada
Princess Margaret Cancer CentreM5G 2C4, TorontoOntario, Canada
Research Institute of McGill University Health CentreH3H 2R9, MontrealQuebec, Canada
France
Hopsital Institut Curie75248, ParisFrance, France
Oncopole Claudius Regaud IUCT31100, ToulouseFrance, France

Sponsors and collaborators

Marengo Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov