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NCT Number: NCT06276491

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

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Germ Cell Tumor Gonadal Disorders Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Ovarian Diseases Ovarian Germ Cell Tumor Ovarian Neoplasms Testicular Diseases Testicular Germ Cell Tumor Testicular Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Herlev Gentofte Hospital, Herlev, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

XmAb541

Biological

Monoclonal bispecific antibody

Primary outcomes

  1. Incidence of adverse events

    Time frame: Day 1 to 2 years

  2. Incidence of dose-limiting toxicities (DLTs)

    Time frame: Day 1 to Day 28

  3. Incidence of cytokine release syndrome (CRS)

    Time frame: Day 1 to Day 28

Secondary outcomes

  1. Measurement of Cmax

    Time frame: Day 1 to 2 years

    Peak plasma concentration

  2. Measurement of area under curve (AUC)

    Time frame: Day 1 to 1.4 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 Response Objective Response Rate by RECIST 1.1 assessment of CT/MRI imaging

  6. Changes in Circulating Tumor DNA (ctDNA)

    Time frame: Day 1 to 4 months

    Maximum variant frequency or mean/median variant frequency

Study contacts

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

XmAb541-01 Central Contact

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Xencor, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Feb 26, 2024
Registry last updated
Jun 11, 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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