What this study is
A Study of Emi-Le in Participants with Solid Tumors
What's being tested
- Emi-Le
Intervention · DRUG
Emi-Le will be administered through a vein in your arm or port catheter (intravenously)
Study details
- Official title
- A Phase 1/2, First-in-human, Multicenter Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors
- Sponsor
- Day One Biopharmaceuticals, Inc.
- Conditions
- Triple Negative Breast Cancer · Breast Cancer · Endometrial Cancer · Ovarian Cancer · Fallopian Tube Cancer · Primary Peritoneal Cavity Cancer · Adenoid Cystic Carcinoma
- Enrolling
- 360 people
- Starts
- 2022-08-15
- Est. completion
- 2027-12
- Design
- Open-label, single group, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify 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 obtain tumor tissue for local testing, if not medically contraindicated, prior to Cycle 1 Day 1
- Brain magnetic resonance imaging (MRI) during the Screening period unless obtained within 30 days prior to Screening (based on standard clinical care), if they meet either of the following criteria:; All participants with TNBC; Participants with a history of brain metastases or with neurologic symptoms or signs suspicious for brain metastases.
You can't join if
- 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 small molecule targeted therapy), whichever is less, or palliative radiation therapy to the chest within 3 months of starting study treatment or to other anatomic sites within 14 days of starting study treatment.
- 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 cancer, or carcinoma in situ of the breast or of the cervix.
- 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 interfere with per-protocol evaluations, in the judgment of either the Sponsor or the Investigator.
- Clinically significant cardiovascular disease
- Active keratitis (inflammation of the cornea of the eye)
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (26)
26 openMayo Clinic Comprehensive Cancer Center
Phoenix, Arizona, United States
- Felipe Batalini, MD · Contact
- Felipe Batalini, MD · Principal investigator
RecruitingUC Irvine Health-Chao Family Comprehensive Cancer Center
Orange, California, United States
- Ritesh Parajuli · Contact
- Ritesh Parajuli · Principal investigator
RecruitingUCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States
- Laura Huppert, MD · Contact
- Laura Huppert, MD · Principal investigator
RecruitingUCLA David Geffen School of Medicine, Division of Hematology/Oncology
Santa Monica, California, United States
- Nicholas McAndrew, MD · Contact
- Nicholas McAndrew, MD · Principal investigator
RecruitingMayo Clinic - Jacksonville
Jacksonville, Florida, United States
- Pooja Advani, MD · Contact
- Pooja Advani, MD · Principal investigator
RecruitingFlorida Cancer Specialists
Sarasota, Florida, United States
- Judy Wang · Contact
- Judy Wang · Principal investigator
RecruitingMoffitt Cancer Center
Tampa, Florida, United States
- Hyo Han, MD · Contact
- Hyo Han, MD · Principal investigator
RecruitingWinship Cancer Institute, Emory University
Atlanta, Georgia, United States
- Kevin Kalinsky, MD · Contact
RecruitingNorthwestern University
Chicago, Illinois, United States
- Patricia Robinson, MD · Contact
- Patricia Robinson, MD · Principal investigator
RecruitingBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
- Gerburg Wulf, MD · Contact
- Gerburg Wulf, MD · Principal investigator
RecruitingDana-Farber Cancer Institute
Boston, Massachusetts, United States
- Antonio Giordano, MD, PhD · Contact
RecruitingHenry Ford Health Hospital
Detroit, Michigan, United States
- Amy Weise, MD · Contact
RecruitingMayo Clinic - Rochester
Rochester, Minnesota, United States
- Roberto Leon-Ferre, MD · Contact
- Roberto Leon-Ferre, MD · Principal investigator
RecruitingComprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
- Liawaty Ho, MD · Contact
- Liawaty Ho, MD · Principal investigator
RecruitingNew York University Langone Health
New York, New York, United States
- Nancy Chan, MD · Contact
RecruitingICHAN School of Medicine at Mount Sinai
New York, New York, United States
- Amy Tiersten · Contact
- Amy Tiersten · Principal investigator
RecruitingMemorial Sloan Kettering Cancer Center
New York, New York, United States
- Nour Abuhadra, MD · Contact
RecruitingStephenson Cancer Center Oklahoma University Health
Oklahoma City, Oklahoma, United States
- Debra Richardson, MD · Contact
- Debra Richardson, MD · Principal investigator
RecruitingAvera Cancer Institute
Sioux Falls, South Dakota, United States
- David C. Starks, MD · Contact
- David C. Starks, MD · Principal investigator
RecruitingSarah Cannon Research Institute (SCRI)
Nashville, Tennessee, United States
- Erika P Hamilton, MD · Contact
RecruitingTexas Oncology, P.A.
Dallas, Texas, United States
- Joyce O'Shaughnessy, MD · Principal investigator
RecruitingMD Anderson
Houston, Texas, United States
- Funda Meric-Bernstam · Contact
- Funda Meric-Bernstam · Principal investigator
RecruitingHuntsman Cancer Institute
Salt Lake City, Utah, United States
- Kristen Kelley, MD · Contact
- Kristen Kelley, MD · Principal investigator
RecruitingNEXT Oncology Virginia
Fairfax, Virginia, United States
- Alex Spira, MD, PhD · Contact
RecruitingFred Hutchinson Cancer Center
Seattle, Washington, United States
- Jennifer Specht, MD · Contact
RecruitingSummit Cancer Centers
Spokane, Washington, United States
- Arvind Chaudhry, MD, PhD · Contact
Recruiting
Study team
Sponsor
Day One Biopharmaceuticals, Inc.
Study ID MER-XMT-1660-1
Study director
Robert Burger, MD
Day One Biopharmaceuticals, Inc.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.