Ovarian CancerPhase 1NCT06276491
Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors
A Phase 1 study testing XmAb541 in people with Ovarian Cancer and Endometrial Cancer, run by Xencor, Inc. at 27 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Ovarian Cancer, Endometrial Cancer, Germ Cell Tumor
- What is being tested?
- XmAb541
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 282 participants
- Where
- 27 sitesin 6 countries
- Study dates
- 4 Apr 2024to Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
27 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
XmAb541-01 Central Contact contact
27 sites in 6 countries
United States17 sites, 17 recruiting
- Recruiting
Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
- Recruiting
City of Hope
Duarte, California, 91010
- Recruiting
The John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
- Recruiting
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
- Recruiting
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
- Recruiting
Stanford University
Palo Alto, California, 94304
- Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
- Recruiting
University of California San Francisco
San Francisco, California, 94158
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
- Recruiting
Montefiore Einstein Comprehensive Cancer Center
The Bronx, New York, 10461
Spain4 sites, 4 recruiting
- Recruiting
NEXT Oncology - Hospital Quironsalud
Barcelona, 08023
- Recruiting
Clinical Universidad de Navarra
Madrid, 28027
- Recruiting
NEXT Oncology - Hospital Quironsalud
Madrid, 28223
- Recruiting
Clinical Universidad de Navarra
Pamplona, 31008
Belgium3 sites, 3 recruiting
- Recruiting
AZ Groeninge
Kortrijk, 8500
- Recruiting
UZ Leuven
Leuven, 3000
- Recruiting
CHU de Liege
Liège, 4000
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Lyon-Sud
Pierre-Bénite, 69310
United Kingdom1 site, 1 recruiting
- Recruiting
The Christie NHS Foundation Trust
Manchester, M204BX
About this study
Official title: A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors
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.
- Conditions
- Ovarian Cancer, Endometrial Cancer, Germ Cell Tumor, Testicular Germ Cell Tumor, Ovarian Germ Cell Tumor
- Being tested
- XmAb541
- Keywords
- Phase 1, Ovarian Cancer, CLDN6, Testicular Cancer, Germ Cell Tumor, Endometrial Cancer, T-cell Engager
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms, Neoplasms, Germ Cell and Embryonal, Testicular Germ Cell Tumor, Testicular Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XmAb541Biological
Monoclonal bispecific antibody
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation and Dose Expansion of XmAb541 | Experimental | Intravenous or Subcutaneous administration Receives: Biological: XmAb541 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: Day 1 to 2 years
Incidence of dose-limiting toxicities (DLTs)
Measured: Day 1 to Day 28
Incidence of cytokine release syndrome (CRS)
Measured: Day 1 to Day 28
Secondary outcomes (6)
Measurement of Cmax
Peak plasma concentration
Measured: Day 1 to 2 years
Measurement of area under curve (AUC)
Area under the plasma concentration versus time curve
Measured: Day 1 to 1.4 years
Measurement of Ctrough
Plasma concentration before next dose
Measured: Day 1 to 2 years
Objective Response Rate
Objective Response Rate by RECIST 1.1 assessment of CT/MRI imaging
Measured: Day 1 to 2 years
Duration of Response
Duration of Response Objective Response Rate by RECIST 1.1 assessment of CT/MRI imaging
Measured: Day 1 to 2 years
Changes in Circulating Tumor DNA (ctDNA)
Maximum variant frequency or mean/median variant frequency
Measured: Day 1 to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start4 Apr 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Dose escalation and expansion study
- Masking
- None (open label)
- Enrolment
- 282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xencor, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276491
- Sponsor's protocol ID
- XmAb541-01
- Status last verified
- Oct 2026
- First submitted
- 16 Feb 2024
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human, Dose Escalation and Expansion Study to Evaluate the Safety and Tolerability of XmAb541 in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06276491
- Acronym / sponsor ID
- XmAb541-01
- Conditions
- Ovarian Cancer, Endometrial Cancer, Germ Cell Tumor, Testicular Germ Cell Tumor, Ovarian Germ Cell Tumor
- Keywords
- Phase 1, Ovarian Cancer, CLDN6, Testicular Cancer, Germ Cell Tumor, Endometrial Cancer, T-cell Engager
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 282 participants (estimated)
- Lead sponsor
- Xencor, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 26 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Dose escalation and expansion study
| Arm | Type | Receives |
|---|---|---|
| Dose escalation and Dose Expansion of XmAb541 | Experimental | Biological: XmAb541Intravenous or Subcutaneous administration |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XmAb541Monoclonal bispecific antibody | Biological | Dose escalation and Dose Expansion of XmAb541 |
Primary outcome
Incidence of adverse events
Time frame: Day 1 to 2 years
Incidence of dose-limiting toxicities (DLTs)
Time frame: Day 1 to Day 28
Incidence of cytokine release syndrome (CRS)
Time frame: Day 1 to Day 28
6 secondary outcomes
Measurement of Cmax
Time frame: Day 1 to 2 years
Measurement of area under curve (AUC)
Time frame: Day 1 to 1.4 years
Measurement of Ctrough
Time frame: Day 1 to 2 years
Objective Response Rate
Time frame: Day 1 to 2 years
Duration of Response
Time frame: Day 1 to 2 years
Changes in Circulating Tumor DNA (ctDNA)
Time frame: Day 1 to 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
XmAb541-01 Central Contact contact
27 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XmAb541 in people with Ovarian Cancer and Endometrial Cancer, run by Xencor, Inc. at 27 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Spain, Belgium, Denmark, France and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact XmAb541-01 Central Contact (info541-01@xencor.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Day 1 to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.