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

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.

Conditions

Ovarian Cancer, Endometrial Cancer, Germ Cell Tumor, Testicular Germ Cell Tumor, Ovarian Germ Cell Tumor

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Ovarian Cancer
Intervention / Treatment

-

Contacts and Locations

Atlanta

Winship Cancer Institute, Emory University, Atlanta, Georgia, United States, 30322

Detroit

Karmanos Cancer Institute, Detroit, Michigan, United States, 48201

Hackensack

The John Theruer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States, 07601

Bronx

Montefiore Einstein Comprehensive Cancer Center, Bronx, New York, United States, 10461

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

Columbus

The Ohio State University, Columbus, Ohio, United States, 43210

Oklahoma City

OU Health Stephenson Cancer Center, Oklahoma City, Oklahoma, United States, 73104

Nashville

SCRI Oncology Partners, Nashville, Tennessee, United States, 37203

Charlottesville

University of Virginia, Charlottesville, Virginia, United States, 22903

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age ≥ 18 years. For subjects with GCTs, age ≥15 years
  • * CLDN6+ tumor
  • * 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
  • * 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.
  • * Eastern Cooperative Oncology Group performance status of 0-2
  • * Life expectancy ≥ 3 months
  • * Adequate liver, kidney, and bone marrow function
  • * Prior exposure to a CLDN6 targeting product
  • * Ovarian cancer that is platinum refractory, or has rapid progression on most recent prior ≥ second line systemic anticancer therapy
  • * Have known active central nervous system metastases and/or carcinomatous meningitis. Patients with treated brain metastases may participate, provided they are radiologically stable.
  • * Active known or suspected autoimmune disease
  • * Have any condition requiring systemic treatment with corticosteroids, prednisone equivalents, or other immunosuppressive medications within 14 days prior to first dose of study drug
  • * Clinically significant cardiovascular, pulmonary or gastrointestinal disease
  • * Positive test for hepatitis C RNA
  • * Positive test for hepatitis B surface antigen or hepatitis B core antibody (hBcAb)

Ages Eligible for Study

15 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Xencor, Inc.,

Study Record Dates

2028-12