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RecruitingInterventionalPhase 1

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

NCT ID: NCT06276491Sponsor: Xencor, Inc.Last updated: 2026-06-11

Summary

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.

Arms & interventions

  • BiologicalXmAb541

    Monoclonal bispecific antibody

Outcome measures

Primary

  • Incidence of adverse events

    Time frame: Day 1 to 2 years

  • Incidence of dose-limiting toxicities (DLTs)

    Time frame: Day 1 to Day 28

  • Incidence of cytokine release syndrome (CRS)

    Time frame: Day 1 to Day 28

Secondary

  • Measurement of Cmax

    Time frame: Day 1 to 2 years

  • Measurement of area under curve (AUC)

    Time frame: Day 1 to 1.4 years

  • Measurement of Ctrough

    Time frame: Day 1 to 2 years

  • Objective Response Rate

    Time frame: Day 1 to 2 years

  • Duration of Response

    Time frame: Day 1 to 2 years

  • Changes in Circulating Tumor DNA (ctDNA)

    Time frame: Day 1 to 4 months

Eligibility criteria

Sex: AllAge: 15 Years and olderHealthy volunteers: No
Key Inclusion Criteria: * Age ≥ 18 years. For US only: 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 resistant to previous treatment * Adequate Eastern Cooperative Oncology Group performance status * Life expectancy ≥ 3 months * Adequate liver, kidney, and bone marrow function Key Exclusion Criteria: * 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 * Active hepatitis B or hepatitis C

Study locations (17)

City of Hope

Duarte, California, 91010

Recruiting

Stanford

Palo Alto, California, 94304

Recruiting

University of California

San Francisco, California, 94158

Recruiting

Moffitt Cancer Center

Tampa, Florida, 33612

Recruiting

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322

Recruiting

University of Chicago Medical Center

Chicago, Illinois, 60637

Recruiting

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202

Recruiting

Karmanos Cancer Institute

Detroit, Michigan, 48201

Recruiting

University of Minnesota

Minneapolis, Minnesota, 55455

Recruiting

The John Theruer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601

Recruiting

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Recruiting

Montefiore Einstein Comprehensive Cancer Center

The Bronx, New York, 10461

Recruiting

The Ohio State University

Columbus, Ohio, 43210

Recruiting

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104

Recruiting

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

Recruiting

SCRI Oncology Partners

Nashville, Tennessee, 37203

Recruiting

University of Virginia

Charlottesville, Virginia, 22903

Recruiting