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

ConditionsTriple Negative Locally Advanced Non-resectable Breast Cancer HR+, HER2-, Advanced Breast Cancer

Trial statusRecruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorMarengo Therapeutics, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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.

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

Disqualifiers

Vitiligo

Psoriasis

Atopic dermatitis or other autoimmune skin condition not requiring systemic treatment

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

Trial design

Treatments tested in this trial

STAR0602
Sacituzumab Govitecan (SG)

Treatment groups

50 Participants

are divided into 2 treatment groups

Locations

Canada

BC CancerV5Z 1K1, VancouverBritish Columbia, Canada

Princess Margaret Cancer CentreM5G 2C4, TorontoOntario, Canada

United States

UCLA Health90095, Los AngelesCalifornia, United States

USC Norris Comprehensive Cancer Center90033, Los AngelesCalifornia, United States

Sponsors and collaborators

Marengo Therapeutics, Inc.

Lead sponsor

Source ClinicalTrials.gov