Health Trials

A Study of a Selective T Cell Receptor (TCR) Targeting, Bifunctional Antibody-fusion Molecule STAR0602 in Participants With Advanced Solid Tumors

ConditionsAdvanced Solid TumorsGenital Neoplasm, FemaleUrogenital NeoplasmsLung NeoplasmNeoplasms by SitePapillomavirus InfectionEpstein-Barr Virus InfectionsCarcinomaNeoplasmsVulvar NeoplasmsVulvar DiseasesAbdominal Neoplasm
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMarengo Therapeutics, Inc.

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

Sponsors and collaborators

Marengo Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov