Phase 1, Safety and Tolerability Study of XmAb541 and XmAb808 in Advanced Solid Tumors
A Phase 1 Trial, Evaluating the Safety and Tolerability of XmAb541 in Combination With XmAb808 in Advanced Solid Tumors
1 other identifier
interventional
90
1 country
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 ovarian-cancer
Started Jun 2026
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 11, 2026
CompletedFirst Posted
Study publicly available on registry
May 18, 2026
CompletedStudy Start
First participant enrolled
June 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
Study Completion
Last participant's last visit for all outcomes
December 1, 2028
May 18, 2026
May 1, 2026
2.5 years
May 11, 2026
May 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Adverse Events
Day 1 to 2 years
Incidence of dose-limiting toxicities
Day 1 to Day 43
Secondary Outcomes (5)
Measurement of Cmax
Day 1 - 2 years
Measurement of area under curve (AUC)
Day 1 to 2 years
Measurement of Ctrough
Day 1 to 2 years
Objective Response Rate
Day 1 to 2 years
Duration of Response
Day 1 to 2 years
Study Arms (1)
Dose Escalation and Dose Expansion of XmAb541 and XmAb808
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
- Life expectancy ≥ 3 months
- Adequate organ function
You may not qualify if:
- 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
- Clinically significant cardiovascular, pulmonary or gastrointestinal disease
- Active viral hepatitis B or hepatitis C
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xencor, Inc.lead
Study Sites (9)
Xencor Investigative Site
Detroit, Michigan, 48201, United States
Xencor Investigative Site
Omaha, Nebraska, 68198, United States
Xencor Investigative Site
Lake Success, New York, 11042, United States
Xencor Investigative Site
New York, New York, 10029, United States
Xencor Investigative Site
The Bronx, New York, 10461, United States
Xencor Investigative Site
Columbus, Ohio, 43210, United States
Xencor Investigative Site
Oklahoma City, Oklahoma, 73104, United States
Xencor Investigative Site
Fort Worth, Texas, 76104, United States
Xencor Investigative Site
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2026
First Posted
May 18, 2026
Study Start (Estimated)
June 1, 2026
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
May 18, 2026
Record last verified: 2026-05