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NCT Number: NCT07593092

Phase 1, Safety and Tolerability Study of XmAb541 and XmAb808 in Advanced Solid Tumors

The primary purpose of this study is to determine whether the investigational drug XmAb541 in combination with XmAb808 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 in combination with XmAb808 on tumor outcomes.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Xencor Investigative Site, Detroit, Michigan, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years.
  • CLDN6+ tumor
  • Histological or cytological documentation of locally advanced, recurrent, or metastatic high grade serous ovarian carcinoma (HGSOC) including fallopian tube or primary peritoneal origin
  • Adequate Eastern Cooperative Oncology Group performance status
  • Life expectancy ≥ 3 months
  • Adequate organ function

Exclusion criteria

  • Prior exposure to a CLDN6 targeting immune cell engager
  • 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 viral hepatitis B or hepatitis C

Treatment and study plan

XmAb541

Biological

Monoclonal Bispecific Antibody

XmAb808

Biological

Monoclonal Bispecific Antibody

Primary outcomes

  1. Incidence of Adverse Events

    Time frame: Day 1 to 2 years

  2. Incidence of dose-limiting toxicities

    Time frame: Day 1 to Day 43

Secondary outcomes

  1. Measurement of Cmax

    Time frame: Day 1 - 2 years

    Peak Plasma Concentration

  2. Measurement of area under curve (AUC)

    Time frame: Day 1 to 2 years

    Area under the plasma concentration versus time curve

  3. Measurement of Ctrough

    Time frame: Day 1 to 2 years

    Plasma concentration before next dose

  4. Objective Response Rate

    Time frame: Day 1 to 2 years

    Objective Response Rate by RECIST 1.1 assessment of CT/MRI imaging

  5. Duration of Response

    Time frame: Day 1 to 2 years

    Duration of Objective Response Rate by RECIST 1.1 assessment of CT/MRI imaging

Study contacts

Contact information is provided by the study sponsor or research team.

Amber Sarot

CONTACT

[email protected]

Nic Rinella

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Xencor, Inc.

Industry

Registry information

Official study title

A Phase 1 Trial, Evaluating the Safety and Tolerability of XmAb541 in Combination With XmAb808 in Advanced Solid Tumors

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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