Phase 1, Safety and Tolerability Study of XmAb541 and XmA... | NCT07593092

Studies
Phase 1, Safety and Tolerability Study of XmAb541 and XmAb808 in Advanced Solid Tumors

NCT07593092

Sponsor

Xencor, Inc.

Status

Not yet recruiting

Last Update Posted

May 18, 2026Actual

Enrollment

90Estimated

Phase

Phase 1

Conditions

Ovarian Cancer

Interventions

XmAb541
XmAb808

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2026Estimated

Primary Completion Date

Dec 2028Estimated

Completion Date

Dec 2028Estimated

First Submitted Date

May 11, 2026

First Submission Date that Met QC Criteria

May 11, 2026

First Posted Date

May 18, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 11, 2026

Last Update Posted Date

May 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dose Escalation and Dose Expansion of XmAb541 and XmAb808	Experimental		Biological: XmAb541 Biological: XmAb808

Interventions

Name	Type	Description	Arm Group Labels	Other Names
XmAb541	Biological	Monoclonal Bispecific Antibody	Dose Escalation and Dose Expansion of XmAb541 and XmAb808

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Adverse Events		Day 1 to 2 years
Incidence of dose-limiting toxicities		Day 1 to Day 43

Secondary Outcomes

Measure	Description	Time Frame
Measurement of Cmax	Peak Plasma Concentration	Day 1 - 2 years
Measurement of area under curve (AUC)	Area under the plasma concentration versus time curve

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nic Rinella	Contact			info541-02@xencor.com
Amber Sarot	Contact			info541-02@xencor.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xencor Investigative Site		Detroit	Michigan	48201	United States
Xencor Investigative Site

Condition Browse Module

MeSH Terms

ID	Term
D010051	Ovarian Neoplasms

Ancestor Terms

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D010049	Ovarian Diseases

Browse Leaves

Not provided

Browse Branches

Not provided