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.
Brief Title
Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Email
mkistler@xencor.com
Completion Date
Completion Date Type
Estimated
Conditions
Ovarian Cancer
Endometrial Cancer
Germ Cell Tumor
Testicular Germ Cell Tumor
Ovarian Germ Cell Tumor
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)
* 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)
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Keywords
Phase 1
Ovarian Cancer
CLDN6
Testicular Cancer
Germ Cell Tumor
Endometrial Cancer
T-cell Engager
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
15 Years
NCT Id
NCT06276491
Org Class
Industry
Org Full Name
Xencor, Inc.
Org Study Id
XmAb541-01
Overall Status
Recruiting
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Estimated
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
Primary Outcomes
Outcome Measure
Incidence of adverse events
Outcome Time Frame
Day 1 to 2 years
Outcome Measure
Incidence of dose-limiting toxicities (DLTs)
Outcome Time Frame
Day 1 to Day 28
Outcome Measure
Incidence of cytokine release syndrome (CRS)
Outcome Time Frame
Day 1 to Day 28
Secondary Outcomes
Outcome Description
Peak plasma concentration
Outcome Time Frame
Day 1 to 2 years
Outcome Measure
Measurement of Cmax
Outcome Description
Area under the plasma concentration versus time curve
Outcome Time Frame
Day 1 to 1.4 years
Outcome Measure
Measurement of area under curve (AUC)
Outcome Description
Plasma concentration before next dose
Outcome Time Frame
Day 1 to 2 years
Outcome Measure
Measurement of Ctrough
Outcome Description
Objective Response Rate by RECIST 1.1 assessment of CT/MRI imaging
Outcome Time Frame
Day 1 to 2 years
Outcome Measure
Objective Response Rate
Outcome Description
Duration of Response Objective Response Rate by RECIST 1.1 assessment of CT/MRI imaging
Outcome Time Frame
Day 1 to 2 years
Outcome Measure
Duration of Response
Outcome Description
Maximum variant frequency or mean/median variant frequency
Outcome Time Frame
Day 1 to 2 years
Outcome Measure
Changes in Circulating Tumor DNA (ctDNA)
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
15
Investigators
Investigator Type
Principal Investigator
Investigator Name
Eric Feldman
Investigator Email
efeldman@montefiore.org