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

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

Status
Active
Cancer Type
Gynecologic Cancers
Ovarian Cancer
Primary Peritoneal Cancer
Trial Phase
Phase I
Eligibility
15 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT06276491
Protocol IDs
XmAb541-01 (primary)
NCI-2024-03773
Study Sponsor
Xencor, Inc.

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.

Eligibility

  1. Age = 18 years. For subjects with GCTs, age =15 years
  2. CLDN6+ tumor
  3. 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
  4. Have documented progressive disease (PD) on standard-of-care therapies appropriate for the specific tumor type; have exhausted therapies with a survival benefit or the standard therapy has no survival benefit or proven to be ineffective, intolerable, or subject is not a candidate for such available therapy.
  5. Eastern Cooperative Oncology Group performance status of 0-2
  6. Life expectancy = 3 months
  7. Adequate liver, kidney, and bone marrow function Key

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.