Phase 1, Safety and Tolerability Study of XmAb541 and XmAb808 in Advanced Solid Tumors
ConditionOvarian Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorXencor, Inc.
About this trial
The primary purpose of this study is to determine whether the investigational drug XmAb541 in combination with XmAb808 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 in combination with XmAb808 on tumor outcomes.
Eligibility criteria
Qualifiers
Age ≥ 18 years.
CLDN6+ tumor
Histological or cytological documentation of locally advanced, recurrent, or metastatic high grade serous ovarian carcinoma (HGSOC) including fallopian tube or primary peritoneal origin
Adequate Eastern Cooperative Oncology Group performance status
Disqualifiers
Prior exposure to a CLDN6 targeting immune cell engager
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
Trial design
Treatments tested in this trial
- XmAb541
- XmAb808
Treatment groups
90 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov