Triple Negative Locally Advanced Non-resectable Breast Cancer study: STAR0602 vs Sacituzumab Govitecan
Official title 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
ClinicalTrials.gov ID: NCT06827613
What this study is testing
What is STAR0602?
This is an investigational medicine being studied as a potential treatment for triple negative locally advanced non-resectable breast cancer. It is designed to help the body's immune cells recognize and target cancer cells.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if the combination of two drugs is safe and how well it works in treating advanced solid tumors.
- Who it's for
- The study is looking for adults with advanced breast cancer that is either triple-negative or hormone-receptor positive and HER2-negative.
- What's involved
- Participants will receive Invikafusp alfa and Sacituzumab Govitecan, along with regular medical checks and tests to monitor their health.
- Time commitment
- The study involves regular visits to the clinic for treatment and monitoring over a period of time.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
- Symptomatic central nervous system (CNS) metastases must have been treated, be asymptomatic for ≥ 14 days, and meet the following at the time of...
You likely can't join if
- 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
See the full 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.
- 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
- Symptomatic central nervous system (CNS) metastases must have been treated, be asymptomatic for ≥ 14 days, and meet the following at the time of enrollment: No concurrent treatment for CNS disease (eg, surgery...
- 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
- Major surgery or traumatic injury within 8 weeks before first dose of study intervention
- Unhealed wounds from surgery or injury
- Clinically significant cardiovascular/vascular disease, gastrointestinal disorders, inflammatory processes, pulmonary compromises
- Active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days prior to the initiation of study intervention.
- Vaccination with any live virus vaccine within 4 weeks prior to the initiation of study intervention administration. Inactivated annual influenza vaccination is allowed.
- Participants who are known to be human immunodeficiency virus positive or hepatitis B or C positive and have uncontrolled disease.
- 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...
- 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)
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Los Angeles, California, United States
- Boston, Massachusetts, United States
- Columbus, Ohio, United States
- Nashville, Tennessee, United States
- San Antonio, Texas, United States
- Vancouver, British Columbia, Canada
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Los Angeles, California, United States; Boston, Massachusetts, United States; Columbus, Ohio, United States; Nashville, Tennessee, United States; San Antonio, Texas, United States; Vancouver, British Columbia, Canada and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.