BridgeMD
New treatment option for Triple Negative Locally Advanced Non-resectable Breast Cancer
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?
STAR0602 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for triple negative locally advanced non-resectable breast cancer.
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 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.
- 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.
- 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
- 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
- History of known autoimmune disease with exceptions of:
- 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
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.
- 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
- 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...
- History of known autoimmune disease with exceptions of:
- 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. Exceptions may be made for participants who have had allergic...
The study team makes the final eligibility decision.
Where it's taking place
- 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 - 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?
Study sites include 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(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.