RECRUITING

Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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(s) for further study. The study will also evaluate the effect of XmAb541 on tumor outcomes.

Official Title

A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors

Quick Facts

Study Start:2024-04-04
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06276491

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years. For subjects with GCTs, age ≥15 years
  2. * CLDN6+ tumor
  3. * Histological or cytological documentation of locally advanced, recurrent, or metastatic ovarian, fallopian tube, or peritoneal cancer, adenocarcinoma of the endometrium (endometrial cancer, uterine cancer, or carcinoma of the uterine corpus), GCT
  4. * Have documented progressive disease (PD) on standard-of-care therapies appropriate for the specific tumor type; have exhausted therapies with a survival benefit or the standard therapy has no survival benefit or proven to be ineffective, intolerable, or subject is not a candidate for such available therapy.
  5. * Eastern Cooperative Oncology Group performance status of 0-2
  6. * Life expectancy ≥ 3 months
  7. * Adequate liver, kidney, and bone marrow function
  1. * Prior exposure to a CLDN6 targeting product
  2. * Ovarian cancer that is platinum refractory, or has rapid progression on most recent prior ≥ second line systemic anticancer therapy
  3. * Have known active central nervous system metastases and/or carcinomatous meningitis. Patients with treated brain metastases may participate, provided they are radiologically stable.
  4. * Active known or suspected autoimmune disease
  5. * Have any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug
  6. * Clinically significant cardiovascular, pulmonary or gastrointestinal disease
  7. * Positive test for hepatitis C RNA
  8. * Positive test for hepatitis B surface antigen or hepatitis B core antibody (hBcAb)

Contacts and Locations

Study Contact

Mira Kistler, MD
CONTACT
mkistler@xencor.com

Study Locations (Sites)

Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
The John Theruer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Montefiore Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
The Ohio State University
Columbus, Ohio, 43210
United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
United States
SCRI Oncology Partners
Nashville, Tennessee, 37203
United States
University of Virginia
Charlottesville, Virginia, 22903
United States

Collaborators and Investigators

Sponsor: Xencor, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-04
Study Completion Date2028-12

Study Record Updates

Study Start Date2024-04-04
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • Phase 1
  • Ovarian Cancer
  • CLDN6
  • Testicular Cancer
  • Germ Cell Tumor
  • Endometrial Cancer
  • T-cell Engager

Additional Relevant MeSH Terms

  • Ovarian Cancer
  • Endometrial Cancer
  • Germ Cell Tumor
  • Testicular Germ Cell Tumor
  • Ovarian Germ Cell Tumor