Brief Summary
The primary purpose of this study is to determine whether the combination of the investigational drug XmAb541 in combination with the investigational drug 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 participants' tumor outcomes.
Brief Title
Phase 1, Safety and Tolerability Study of XmAb541 and XmAb808 in Advanced Solid Tumors
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Email
info541-02@xencor.com
Completion Date
Completion Date Type
Estimated
Conditions
OVARIAN CANCER
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
* 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
Inclusion 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
* 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
Gender
Female
Gender Based
false
Keywords
Phase 1
Ovarian Cancer
HGSOC
B7H3
CLDN6
T-cell Engager
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT07593092
Org Class
Industry
Org Full Name
Xencor, Inc.
Org Study Id
XmAb541-02
Overall Status
Recruiting
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
A Phase 1 Trial, Evaluating the Safety and Tolerability of XmAb541 in Combination With XmAb808 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
Outcome Time Frame
Day 1 to Day 43
Secondary Outcomes
Outcome Description
Peak Plasma Concentration
Outcome Time Frame
Day 1 - 2 years
Outcome Measure
Measurement of Cmax
Outcome Description
Area under the plasma concentration versus time curve
Outcome Time Frame
Day 1 to 2 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 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
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
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Nicole Nevadunsky
Investigator Email
nnevadun@montefiore.org
Investigator Phone
718-405-8082
Investigator Department
Obstetrics & Gynecology and Womens Health
Investigator Division
Gynecological Oncology
Investigator Sponsor Organization
External
Study Department
Obstetrics & Gynecology and Women`s Health
Study Division
Gynecologic Oncology
Categories Mesh Debug
Endocrine System Cancers --- ENDOCRINE GLAND NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
Gynecologic Cancers --- GENITAL NEOPLASMS, FEMALE
Genitourinary (GU) & Urologic Cancers --- UROGENITAL NEOPLASMS
Diabetes --- ENDOCRINE SYSTEM DISEASES
Diabetes & Endocrine System --- ENDOCRINE SYSTEM DISEASES
MeSH Terms
OVARIAN NEOPLASMS
ENDOCRINE GLAND NEOPLASMS
NEOPLASMS BY SITE
NEOPLASMS
OVARIAN DISEASES
ADNEXAL DISEASES
GENITAL DISEASES, FEMALE
FEMALE UROGENITAL DISEASES
FEMALE UROGENITAL DISEASES AND PREGNANCY COMPLICATIONS
UROGENITAL DISEASES
GENITAL NEOPLASMS, FEMALE
UROGENITAL NEOPLASMS
GENITAL DISEASES
ENDOCRINE SYSTEM DISEASES
GONADAL DISORDERS