Ovarian CancerPhase 1NCT07593092
Phase 1, Safety and Tolerability Study of XmAb541 and XmAb808 in Advanced Solid Tumors
A Phase 1 study testing XmAb541 and XmAb808 in people with Ovarian Cancer, run by Xencor, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- XmAb541 and XmAb808
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 Jun 2026to 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
541-02 Study Information contact
United States4 sites, 4 recruiting
- Recruiting
Xencor Investigative Site
Fort Worth, Texas, 76104
- Recruiting
Xencor Investigative Site
Lake Success, New York, 11042
- Recruiting
Xencor Investigative Site
New York, New York, 10029
- Recruiting
Xencor Investigative Site
The Bronx, New York, 10461
About this study
Official title: A Phase 1 Trial, Evaluating the Safety and Tolerability of XmAb541 in Combination With XmAb808 in Advanced Solid Tumors
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.
- Conditions
- Ovarian Cancer
- Being tested
- XmAb541, XmAb808
- Keywords
- Phase 1, Ovarian Cancer, HGSOC, B7H3, CLDN6, T-cell Engager
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XmAb541Biological
Monoclonal Bispecific Antibody
XmAb808Biological
Monoclonal Bispecific Antibody
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation and Dose Expansion of XmAb541 and XmAb808 | Experimental | Not described Receives: Biological: XmAb541; Biological: XmAb808 |
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
Measured: Day 1 to Day 43
Secondary outcomes (5)
Measurement of Cmax
Peak Plasma Concentration
Measured: Day 1 - 2 years
Measurement of area under curve (AUC)
Area under the plasma concentration versus time curve
Measured: Day 1 to 2 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 Objective Response Rate by RECIST 1.1 assessment of CT/MRI imaging
Measured: Day 1 to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start30 Jun 2026
- Primary completionDec 2028 (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
- Masking
- None (open label)
- Enrolment
- 90 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
- NCT07593092
- Sponsor's protocol ID
- XmAb541-02
- Status last verified
- Aug 2026
- First submitted
- 11 May 2026
- Last updated
- 13 Aug 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 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Trial, Evaluating the Safety and Tolerability of XmAb541 in Combination With XmAb808 in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07593092
- Acronym / sponsor ID
- XmAb541-02
- Conditions
- Ovarian Cancer
- Keywords
- Phase 1, Ovarian Cancer, HGSOC, B7H3, CLDN6, T-cell Engager
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Xencor, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 18 May 2026 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation and Dose Expansion of XmAb541 and XmAb808 | Experimental | Biological: XmAb541, Biological: XmAb808 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 and XmAb808 |
| XmAb808Monoclonal Bispecific Antibody | Biological | Dose Escalation and Dose Expansion of XmAb541 and XmAb808 |
Primary outcome
Incidence of Adverse Events
Time frame: Day 1 to 2 years
Incidence of dose-limiting toxicities
Time frame: Day 1 to Day 43
5 secondary outcomes
Measurement of Cmax
Time frame: Day 1 - 2 years
Measurement of area under curve (AUC)
Time frame: Day 1 to 2 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
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 13 Aug 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.
541-02 Study Information contact
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XmAb541 and XmAb808 in people with Ovarian Cancer, run by Xencor, Inc. at 4 sites in United States.
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 6 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 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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 541-02 Study Information (info541-02@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 2 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 13 Aug 2026.