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Study of Invikafusp Alfa and Sacituzumab Govitecan for Advanced Breast Cancer

This study is testing a combination of two drugs, Invikafusp alfa (STAR0602) and Sacituzumab Govitecan, for people with advanced breast cancer that is either triple-negative (mTNBC) or hormone receptor-positive and HER2-negative (HR+/HER2- mBC). The study aims to see how safe this combination is and how well it shrinks tumors. You might be eligible if you have measurable advanced breast cancer that has progressed or come back. Researchers will be looking at side effects and how many people's tumors respond to the treatment over time. The study plans to enroll about 50 participants.

Study design
This is an open-label, Phase 1b/2 study, meaning both you and your doctors will know which treatments you are receiving. It plans to enroll about 50 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety and tumor response for up to 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06827613

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
PHASE1Ages 18+InterventionalTreatment
Marengo Therapeutics, Inc.
~50 participants
Updated 2025-09-24 on ClinicalTrials.gov
What's tested:STAR0602Sacituzumab Govitecan (SG)

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1 (Safety Run-In): Number of Participants with Dose Limiting Toxicites (DLTs)
Measured over 21 days following the first dose of STAR0602 + Sacituzumab Govitecan
+2 more outcomes measured

Conditions

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

Explore related trials

Breast CarcinomaTriple-negative breast cancer

Where it's being run

8 sites across 7 states
California2
Massachusetts1
Ohio1
Tennessee1
Texas1
British Columbia1
Ontario1

Who to contact

Kevin Chin, MD, MS
[email protected]
617-276-5734
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 3. Symptomatic central nervous system (CNS) metastases must have been treated, be asymptomatic for ≥ 14 days, and meet the following at the time of enrollment:

Exclusion

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
Alopecia
Arthritis managed without systemic therapy beyond oral nonsteroidal anti-inflammatory drugs
Adrenal insufficiency well-controlled on replacement therapy 2. Major surgery or traumatic injury within 8 weeks before first dose of study intervention 3. Unhealed wounds from surgery or injury 4. Clinically significant cardiovascular/vascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises 5. Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study intervention. 6. Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study intervention administration. Inactivated annual influenza vaccination is allowed. 7. Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease. 8. Second primary invasive malignancy not in remission for ≥ 1 year. Exceptions include non-melanoma locally advanced skin cancer, cervical carcinoma in situ, localized prostate cancer (Gleason score ≤ 7), resected melanoma in situ, or any malignancy considered to be indolent and never required systemic therapy, with the exception of indolent lymphomas. 9. Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation) 10. Treatment with \>10 mg per day of prednisone (or equivalent) or other immune-suppressive drugs within 7 days prior to the initiation of study intervention. Exceptions may be made for participants who have had allergic reactions to iodinated contrast media. Steroids for topical, ophthalmic, inhaled, or nasal administration are allowed

What this trial measures

  • Phase 1 (Safety Run-In): Number of Participants with Dose Limiting Toxicites (DLTs)21 days following the first dose of STAR0602 + Sacituzumab Govitecan
  • Phase 1 and 2 (Safety Run-In and Cohort Expansion): Number of Participants with Adverse Events and Serious Adverse EventsUp to 3 years
  • Phase 1 and 2 (Safety Run-In and Cohort Expansion): Percentage of participants with Overall Objective Tumor Responses (ORR)Up to 3 years

    Proportion of participants who have a complete response (CR) or partial response (PR)