Triple Negative Breast Cancer study: Emi-Le
Official title A Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors
ClinicalTrials.gov ID: NCT05377996
What this study is testing
What is Emi-Le?
an investigational intravenous medicine being studied as a potential treatment for triple negative breast cancer and other solid tumors
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 is testing whether Emi-Le is safe and how well it works in people with solid tumors.
- Who it's for
- You may be able to join if you have one of the listed solid tumors and meet the study’s health requirements.
- What's involved
- You will receive Emi-Le (a new medicine) and have regular doctor visits and lab tests to check your health.
- Time commitment
- The study lasts several months and requires visits every few weeks for treatment and check‑ups.
- 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
- Recurrent or advanced solid tumor and has disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Participants in DES must have at least one measurable disease (target) lesion as defined by RECIST version 1.1.
- Tumor tissue, either archival or from a fresh tumor biopsy, available for testing or be willing to undergo a minimally invasive tumor biopsy to...
- All participants with TNBC
You likely can't join if
- Prior treatment with an Antibody Drug Conjugate (ADC) containing an auristatin payload.
- Major surgery within 28 days of starting study treatment, systemic anticancer therapy within the time period of 28 days or 5 half-lives of the prior...
- Diagnosis of additional malignancy that required active treatment (including surgery, systemic therapy, and radiation) within 2 years prior to...
- Untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis or carcinomatous meningitis.
- Prior B7-H4 targeted treatment.
- History of cirrhosis, hepatic fibrosis, esophageal or gastric varices, or other clinically significant liver diseases.
See the full eligibility criteria
- Recurrent or advanced solid tumor and has disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Participants in DES must have at least one measurable disease (target) lesion as defined by RECIST version 1.1.
- Tumor tissue, either archival or from a fresh tumor biopsy, available for testing or be willing to undergo a minimally invasive tumor biopsy to obtain tumor tissue for local testing, if not medically contraindicated...
- All participants with TNBC
- Participants with a history of brain metastases or with neurologic symptoms or signs suspicious for brain metastases.
- Prior treatment with an Antibody Drug Conjugate (ADC) containing an auristatin payload. Prior treatment with another ADC containing other payloads is allowed.
- Major surgery within 28 days of starting study treatment, systemic anticancer therapy within the time period of 28 days or 5 half-lives of the prior therapy before starting study treatment (14 days or 5 half-lives for...
- Diagnosis of additional malignancy that required active treatment (including surgery, systemic therapy, and radiation) within 2 years prior to screening, except for adequately treated basal cell or squamous cell skin...
- Untreated CNS metastases (including new and progressive brain metastases), history of leptomeningeal metastasis or carcinomatous meningitis.
- Prior B7-H4 targeted treatment.
- History of cirrhosis, hepatic fibrosis, esophageal or gastric varices, or other clinically significant liver diseases.
- Current severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease) or intercurrent illness that could increase the risk of serious adverse events (SAEs) or...
- Clinically significant cardiovascular disease
- Active keratitis (inflammation of the cornea of the eye)
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Orange, California, United States
- San Francisco, California, United States
- Santa Monica, California, United States
- Jacksonville, Florida, United States
- Sarasota, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- Las Vegas, Nevada, United States
- New York, New York, United States
- Oklahoma City, Oklahoma, United States
- Sioux Falls, South Dakota, United States
- Nashville, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
+ 3 more site(s).
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 Phoenix, Arizona, United States; Orange, California, United States; San Francisco, California, United States; Santa Monica, California, United States; Jacksonville, Florida, United States; Sarasota, Florida, United States and 17 more locations. 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.