Endometrial Cancer, Germ Cell Tumor, Ovarian Cancer, Ovarian Germ Cell Tumor, Testicular Germ Cell Tumor
Conditions
Keywords
Phase 1, Ovarian Cancer, CLDN6, Testicular Cancer, Germ Cell Tumor, Endometrial Cancer, T-cell Engager
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.
Interventions
BIOLOGICALXmAb541
Monoclonal bispecific antibody
Sponsors
Xencor, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Dose escalation and expansion study
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Age ≥ 18 years. For US only: 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
* Participants with untreated brain metastases are excluded. Participants 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | Day 1 to 2 years |
| Incidence of dose-limiting toxicities (DLTs) | Day 1 to Day 28 |
| Incidence of cytokine release syndrome (CRS) | Day 1 to Day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of Cmax | Day 1 to 2 years | Peak plasma concentration |
| Measurement of area under curve (AUC) | Day 1 to 1.4 years | Area under the plasma concentration versus time curve |
| Measurement of Ctrough | Day 1 to 2 years | Plasma concentration before next dose |
| Objective Response Rate | Day 1 to 2 years | Objective Response Rate by RECIST 1.1 assessment of CT/MRI imaging |
| Duration of Response | Day 1 to 2 years | Duration of Response Objective Response Rate by RECIST 1.1 assessment of CT/MRI imaging |
| Changes in Circulating Tumor DNA (ctDNA) | Day 1 to 4 months | Maximum variant frequency or mean/median variant frequency |
Countries
Belgium, Denmark, Spain, United States
Contacts
CONTACTXmAb541-01 Central Contact
Outcome results
None listed