A Study of XMT-1660 in Participants With Solid Tumors

Launched by MERSANA THERAPEUTICS · May 11, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called XMT-1660 for patients with certain types of solid tumors, including different forms of breast cancer, ovarian cancer, and others. The main goal is to see how well this new treatment works for people whose cancer has returned or advanced. The trial is currently looking for participants aged 65 to 74, and both men and women can join.

To be eligible for this trial, participants need to have a specific type of cancer that has either come back or progressed, and they should be in reasonably good health according to a performance scale used in cancer research. Participants will need to provide a sample of their tumor for testing, which may involve a simple biopsy, and they'll undergo some imaging tests to check for any brain involvement if they have certain types of breast cancer or prior brain issues. If you or a loved one is considering joining this study, you can expect to receive the investigational treatment along with regular monitoring to evaluate its effects. It's important to note that there are some health conditions and prior treatments that might prevent someone from participating, so discussing eligibility with a healthcare provider is essential.

Gender

ALL

Eligibility criteria

• 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 non-target lesion as defined by RECIST version 1.1. Participants in Backfill Cohorts and EXP 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