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 1Phase 2Interventional Study
Triple Negative Locally Advanced Non-resectable Breast CancerHR+, 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 outActive 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?
Answer a few quick questions to see if you may meet the eligibility requirements.
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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Status
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
…
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
* 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:
No concurrent treatment for CNS disease (eg, surgery, radiation, corticosteroids \> 10 mg prednisone/day or equivalent); No concurrent leptomeningeal disease or cord compression.
Exclusion Criteria:
1. 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
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
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