A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb®541 in Advanced Solid Tumors

UVA Tracking #
Principal Investigator
Matthew J Reilley
Contact Phone
Official Trial Title
A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb®541 in Advanced Solid Tumors
Study Description

The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with Advanced Solid Tumors (Including Ovarian, fallopian tube, or peritoneal cancer, Adenocarcinoma of the endometrium [endometrial cancer, uterine cancer, or carcinoma of the uterine corpus] Germ cell tumor) for a research study. The primary purpose of this study is to determine whether the investigational drug XmAb541 is safe and well tolerated, and to determine an optimal and safe dose for further study (the recommended dose). An investigational drug is a drug which has not been approved by the United States Food and Drug Administration (FDA), the health authority which gives approval for new medicines to be prescribed in the United States. The study will also evaluate if XmAb541 has any effect on your advanced solid tumor cancer.

The study involves receiving the investigational drug, as well as coming in for study visits, which include exams, laboratory tests, and procedures such as having your blood drawn, imaging of your tumor, and talking to the study doctor. If you are eligible for the study and consent to participate, your involvement will include a screening period, treatment period, and post-treatment period. The screening period will last up to 4 weeks to determine your eligibility for the study. The treatment period will consist of receiving the study drug (XmAb541). You will be admitted to the hospital for monitoring after the first three doses of XmAb541. After the first dose, you will be admitted for approximately 48 hours and for the second and third doses the admission is for approximately 24 hours. Doses other than the first three may require admission for your safety. The hospital admission is to follow you for how well you tolerate the increasing doses of study drug. You will continue to receive the study drug every 3 weeks for a maximum of 24 months from the first dose until you have an unacceptable side effect, your cancer worsens, or the study doctor believes there is no longer any benefit for you to continue. The post-treatment period will include phone calls from the study team to check your health status every 3 months for up to 24 months.

The study drug, XmAb541, will be provided by the sponsor at no cost to you. All additional study procedures, including laboratory tests, physical examinations, and visits to the study center are provided to you at no charge.

Additional information can be found here: https://clinicaltrials.gov/study/NCT06276491



None Travel Reimbursement - $70 Meal Reimbursement - $51 Hotel Reimbursement – Up to $359