Phase 1, Safety and Tolerability Study of XmAb®541 in Advanced Solid Tumors

Ovarian Cancer Clinical Trial

Official title:

A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb®541 in Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06276491
• Other study ID #: XmAb541-01
• Status: Recruiting
• Phase: Phase 1
• Start date: April 4, 2024
• Est. completion date: December 2028

Study information

• Verified date: April 2024
• Source: Xencor, Inc.
• Contact: Michael Chiarella
• Phone: 1-858-945-2415
• Email: mchiarella[@]xencor.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 effect of XmAb541 on tumor outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 212
• Est. completion date: December 2028
• Est. primary completion date: December 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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, thyroid 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
• Known Human immunodeficiency virus (HIV) positivity
• Positive test for hepatitis C RNA
• Positive test for hepatitis B surface antigen or hepatitis B core antibody (hBcAb)

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Germ Cell Tumor
• Neoplasms
• Neoplasms, Germ Cell and Embryonal
• Ovarian Cancer
• Ovarian Germ Cell Tumor
• Ovarian Neoplasms
• Testicular Germ Cell Tumor

Intervention

Biological:
• XmAb541
Monoclonal bispecific antibody

Locations

Country	Name	City	State
United States	Montefiore Einstein Comprehensive Cancer Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Xencor, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events		Day 1 to 2 years
Primary	Incidence of dose-limiting toxicities (DLTs)		Day 1 to Day 28
Primary	Incidence of cytokine release syndrome (CRS)		Day 1 to Day 28
Secondary	Measurement of Cmax	Peak plasma concentration	Day 1 to 2 years
Secondary	Measurement of area under curve (AUC)	Area under the plasma concentration versus time curve	Day 1 to 1.4 years
Secondary	Measurement of Ctrough	Plasma concentration before next dose	Day 1 to 2 years
Secondary	Objective Response Rate	Objective Response Rate by RECIST 1.1 assessment of CT/MRI imaging	Day 1 to 2 years
Secondary	Duration of Response	Duration of Response Objective Response Rate by RECIST 1.1 assessment of CT/MRI imaging	Day 1 to 2 years
Secondary	Changes in Circulating Tumor DNA (ctDNA)	Maximum variant frequency or mean/median variant frequency	Day 1 to 2 years