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

NCT06276491 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: XmAb541-01
• Study Type: interventional
• Target: 282
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Ovarian Cancer; Endometrial Cancer; Germ Cell Tumor; Ovarian Germ Cell Tumor; Testicular Germ Cell Tumor

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Incidence of adverse events

  Day 1 to 2 years

• Incidence of dose-limiting toxicities (DLTs)

  Day 1 to Day 28

• Incidence of cytokine release syndrome (CRS)

  Day 1 to Day 28

Secondary Outcomes (6)

• Measurement of Cmax

  Day 1 to 2 years

• Measurement of area under curve (AUC)

  Day 1 to 1.4 years

• Measurement of Ctrough

  Day 1 to 2 years

• Objective Response Rate

  Day 1 to 2 years

• Duration of Response

  Day 1 to 2 years

Study Arms (1)

Dose escalation and Dose Expansion of XmAb541

EXPERIMENTAL

Intravenous or Subcutaneous administration

Biological: XmAb541

Interventions

XmAb541 BIOLOGICAL

Monoclonal bispecific antibody

Dose escalation and Dose Expansion of XmAb541

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 resistant to previous treatment
• Adequate Eastern Cooperative Oncology Group performance status
• Life expectancy ≥ 3 months
• Adequate liver, kidney, and bone marrow function

You may not qualify if:

• 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

Sponsors & Collaborators

• Xencor, Inc.: lead

Study Sites (16)

City of Hope

Duarte, California, 91010, United States

NOT YET RECRUITING

Stanford

Palo Alto, California, 94304, United States

NOT YET RECRUITING

University of California

San Francisco, California, 94158, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Winship Cancer Institute, Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

Indian University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

The John Theruer Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Montefiore Einstein Comprehensive Cancer Center

The Bronx, New York, 10461, United States

RECRUITING

The Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

University of Virginia

Charlottesville, Virginia, 22903, United States

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms; Neoplasms, Germ Cell and Embryonal; Testicular Germ Cell Tumor; Testicular Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases; Neoplasms by Histologic Type; Genital Neoplasms, Male; Genital Diseases, Male; Male Urogenital Diseases; Testicular Diseases

Central Study Contacts

Gabrielle Golden

CONTACT

info541-01@xencor.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation and expansion study

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: February 26, 2024
• Study Start: April 4, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

US (16)