Clinical trial NCT06276491: Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Ovarian Cancer
Endometrial Cancer
Germ Cell Tumor
Testicular Germ Cell Tumor
Ovarian Germ Cell Tumor
Keywords: Phase 1
Ovarian Cancer
CLDN6
Testicular Cancer
Germ Cell Tumor
Endometrial Cancer
T-cell Engager
Lead sponsor: Xencor, Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-26
Enrollment: 212
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Dose escalation and expansion study
Primary purpose: TREATMENT

Brief 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 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
* 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
* 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
* Positive test for hepatitis C RNA
* Positive test for hepatitis B surface antigen or hepatitis B core antibody (hBcAb)

Primary outcomes:
measure: Incidence of adverse events
timeFrame: Day 1 to 2 years
measure: Incidence of dose-limiting toxicities (DLTs)
timeFrame: Day 1 to Day 28
measure: Incidence of cytokine release syndrome (CRS)
timeFrame: Day 1 to Day 28
Secondary outcomes:
measure: Measurement of Cmax
timeFrame: Day 1 to 2 years
measure: Measurement of area under curve (AUC)
timeFrame: Day 1 to 1.4 years
measure: Measurement of Ctrough
timeFrame: Day 1 to 2 years
measure: Objective Response Rate
timeFrame: Day 1 to 2 years
measure: Duration of Response
timeFrame: Day 1 to 2 years
measure: Changes in Circulating Tumor DNA (ctDNA)
timeFrame: Day 1 to 2 years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Hackensack
country: United States
facility: The John Theruer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Einstein Comprehensive Cancer Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: OU Health Stephenson Cancer Center
state: Oklahoma
city: Nashville
country: United States
facility: SCRI Oncology Partners
state: Tennessee
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References: