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

a study on Ovarian Cancer Endometrial Cancer Germ Cell Tumor Solid Tumor Testicular Cancer

Summary

Eligibility
for people ages 15 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around
Principal Investigator
by Rahul Aggarwal
Headshot of Rahul Aggarwal
Rahul Aggarwal

Description

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.

Official Title

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

Keywords

Ovarian Cancer, Endometrial Cancer, Germ Cell Tumor, Testicular Germ Cell Tumor, Ovarian Germ Cell Tumor, Phase 1, CLDN6, Testicular Cancer, T-cell Engager, Ovarian Neoplasms, Endometrial Neoplasms, Germ Cell and Embryonal Neoplasms, Testicular Neoplasms, XmAb541

Eligibility

You can join if…

Open to people ages 15 years and up

  • 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 CAN'T join 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

Locations

  • University of California accepting new patients
    San Francisco California 94158 United States
  • Stanford not yet accepting patients
    Palo Alto California 94304 United States
  • OU Health Stephenson Cancer Center accepting new patients
    Oklahoma City Oklahoma 73104 United States

Lead Scientist at UCSF

  • Rahul Aggarwal
    I am a Medical Oncologist within the Division of Hematology/Oncology at the University of California San Francisco. My clinical practice focuses on patients with advanced solid tumor malignancies with a particular emphasis on genitourinary malignancies including prostate, kidney, bladder, and testicular cancer.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Xencor, Inc.
ID
NCT06276491
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 282 study participants
Last Updated
Contact us about this trial