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Not yet recruiting NCT07593092

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

Phase I Interventional Ovarian Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: XmAb541, XmAb808.
Who it may be relevant to
Registry conditions: Ovarian Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Biological XmAb541
    Monoclonal Bispecific Antibody
  • Biological XmAb808
    Monoclonal Bispecific Antibody

Primary outcome measures

  • Incidence of Adverse Events [Time frame: Day 1 to 2 years]
  • Incidence of dose-limiting toxicities [Time frame: Day 1 to Day 43]
Secondary outcome measures (5)
  • Measurement of Cmax [Time frame: Day 1 - 2 years]
  • Measurement of area under curve (AUC) [Time frame: Day 1 to 2 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 9 centers
  • Xencor Investigative Site — Detroit
  • Xencor Investigative Site — Omaha
  • Xencor Investigative Site — Lake Success
  • Xencor Investigative Site — New York
  • Xencor Investigative Site — The Bronx
  • Xencor Investigative Site — Columbus
  • Xencor Investigative Site — Oklahoma City
  • Xencor Investigative Site — Fort Worth
  • … and 1 more center

Identifiers

NCT: NCT07593092 · XmAb541-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗