Testing a new drug called XMT-1660 for solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This first-in-human study evaluates the safety and side effects of XMT-1660 in participants with recurrent or advanced solid tumors, including triple negative breast cancer and ovarian cancer. The trial consists of two parts: a Dose Escalation phase to determine the appropriate dosage and a Dose Expansion phase to assess the drug's safety and efficacy. Participants will undergo tumor tissue testing and may need a biopsy if necessary. The study aims to provide insights into the potential therapeutic benefits of XMT-1660 for patients with difficult-to-treat cancers.

Why it matters

Who can join: the full rules

Inclusion 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, 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:

  1. All participants with TNBC
  2. Participants with a history of brain metastases or with neurologic symptoms or signs suspicious for brain metastases.

Exclusion Criteria:

* 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)

Where it's running

• Mayo Clinic Comprehensive Cancer Center
  Phoenix, Arizona, United States Recruiting
• UC Irvine Health-Chao Family Comprehensive Cancer Center
  Orange, California, United States Recruiting
• UCSF Helen Diller Family Comprehensive Cancer Center
  San Francisco, California, United States Recruiting
• UCLA David Geffen School of Medicine, Division of Hematology/Oncology
  Santa Monica, California, United States Recruiting
• Mayo Clinic - Jacksonville
  Jacksonville, Florida, United States Recruiting
• Florida Cancer Specialists
  Sarasota, Florida, United States Recruiting

Study contacts

• Study coordinator: Day One Clinical Trials Information
• Email: clinicaltrials@dayonebio.com
• Phone: 1-650-484-0899

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.