Phase 1, Safety and Tolerability Study of XmAb®541 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 effect of XmAb541 on tumor outcomes.

Enrollment

212 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 evidence of locally advanced, recurrent, or metastatic solid malignancy Ovarian, fallopian tube, or peritoneal cancer, adenocarcinoma of the endometrium (endometrial cancer, uterine cancer, or carcinoma of the uterine corpus), GCT
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.
Eastern Cooperative Oncology Group performance status of 0-2
Life expectancy ≥ 3 months
Adequate liver, kidney, and bone marrow function

Key Exclusion Criteria:

Prior exposure to a CLDN6 targeting product
Ovarian cancer that is platinum refractory, or has rapid progression on most recent prior ≥ second line systemic anticancer therapy
Have known active central nervous system metastases and/or carcinomatous meningitis. Patients with treated brain metastases may participate, provided they are radiologically stable.
Active known or suspected autoimmune disease
Has 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
Positive test for hepatitis C RNA
Positive test for hepatitis B surface antigen or hepatitis B core antibody (hBcAb)