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

This is a Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp alfa (STAR0602), a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Combination with Sacituzumab Govitecan in Participants with Unresectable, Locally Advanced, or Metastatic Solid Tumors.

Trial Details

NCT ID
NCT06827613
Phase
PHASE1 / PHASE2
Sponsor
Marengo Therapeutics, Inc.
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • STAR0602
  • Sacituzumab Govitecan (SG)
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Los Angeles, California, United States|34.05223,-118.24368
  • Boston, Massachusetts, United States|42.35843,-71.05977
  • Columbus, Ohio, United States|39.96118,-82.99879
  • Nashville, Tennessee, United States|36.16589,-86.78444

Key Eligibility Criteria

  • Have measurable disease as per RECIST v1.1 criteria and documented by CT and/or MRI. Cutaneous or subcutaneous lesions must be measurable by calipers.
  • Tumor Type:
  • mTNBC (Safety Run-in and Cohort A): Progression or recurrence of locally advanced or metastatic TNBC
  • HR+/HER2- mBC (Safety Run-in and Cohort B): Progression or recurrence of locally advanced or metastatic HR+/HER2- breast cancer

For full eligibility, visit ClinicalTrials.gov.

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