Invikafusp Alfa with Sacituzumab for Advanced Breast Cancer

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

Recruiting Phase 1 Phase 2 Interventional Study
Triple Negative Locally Advanced Non-resectable Breast Cancer HR+, HER2-, Advanced Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Marengo Therapeutics, Inc. · Industry
Who this trial is looking for

This trial is looking for people with advanced breast cancer that cannot be surgically removed. Participants will receive a treatment that combines two medications to see how well they work together and to check for any side effects.

Are You a Good Fit for This Trial?
Rules you out Active viral infectionActive bacterial infectionActive fungal infection

You may be able to join if

  • I have measurable disease confirmed by imaging tests.
  • I have locally advanced or metastatic triple-negative breast cancer.
  • I have locally advanced or metastatic HR+/HER2- breast cancer.
  • I have been treated for central nervous system metastases and remain asymptomatic.

You may not be able to join if

  • I have a history of significant autoimmune disease.
  • I have had major surgery or injury within the last 8 weeks.
  • I currently have unhealed wounds.
  • I have serious heart, lung, or gut problems.
  • I have an active infection that needs treatment.
  • I have been vaccinated with a live virus vaccine in the last 4 weeks.
  • I am pregnant, planning to become pregnant, or breastfeeding.
  • I have taken more than 10 mg of prednisone per day within the last week.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. 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. 2. Tumor Type: * mTNBC (Safety Run-in and Cohort A): Progression or recurrence of locally advanced or metastatic TNBC …
Contacts

Kevin Chin, MD, MS

617-276-5734

kchin@marengotx.com

CONTACT