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

Xencor

Status and phase

Enrolling

Phase 1

Conditions

Endometrial Cancer

Germ Cell Tumor

Ovarian Cancer

Ovarian Germ Cell Tumor

Testicular Germ Cell Tumor

Treatments

Biological: XmAb541

Study type

Interventional

Funder types

Industry

Identifiers

NCT06276491

XmAb541-01

Details and patient eligibility

About

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.

Enrollment

282 estimated patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

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

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