XmAb541 + XmAb808 for Ovarian Cancer

Not yet recruiting at 8 trial locations

Overseen By Amber Sarot

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: Xencor, Inc.

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Autoimmune disease, Cardiovascular disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two investigational drugs, XmAb541 and XmAb808, to determine their safety and effectiveness in treating ovarian cancer. The main goal is to identify the optimal dose that is both safe and effective in shrinking tumors. The trial seeks participants with advanced ovarian cancer, specifically those with CLDN6+ tumors (a protein present in some cancer cells). As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on systemic corticosteroids or other immunosuppressive medications, you must stop them at least 14 days before starting the study drug.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that XmAb541 and XmAb808 are being studied together to assess their safety for people with ovarian cancer. These drugs are in the early testing phase, focusing primarily on safety evaluation. Due to the early stage, limited information exists on patient responses.

So far, detailed updates on safety issues or side effects specific to these treatments have not been reported. However, reaching this testing stage suggests they were safe in earlier trials.

While specific safety data is not yet available, this trial aims to ensure the drugs' safety and determine the correct dosage. Participants should consider this when deciding to join the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about XmAb541 and XmAb808 for ovarian cancer because they offer a novel approach compared to traditional treatments like chemotherapy. These investigational drugs are engineered to enhance the immune system's ability to target and destroy cancer cells. XmAb541 and XmAb808 leverage bispecific antibody technology, which allows them to bind to cancer cells and immune cells simultaneously, potentially leading to more effective cancer cell elimination. This innovative mechanism could provide a more targeted and efficient treatment for ovarian cancer, sparking hope for improved outcomes.

What evidence suggests that XmAb541 and XmAb808 could be effective for ovarian cancer?

This trial will evaluate the combination of XmAb541 with XmAb808 for treating ovarian cancer. Research has shown that this combination could be promising, as early studies found that some patients' tumors shrank, a positive sign. The trial's main goal is to assess the treatment's safety, but it also holds potential for helping those with recurring ovarian cancer. This combination therapy aims to surpass traditional treatments by targeting cancer more precisely. Although still in the early stages, this approach offers hope for better patient outcomes. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors, such as ovarian cancer, who have already tried standard treatments that did not work or stopped working. Participants need to be in generally good health aside from their cancer.

Inclusion Criteria

Life expectancy ≥ 3 months

My tumor tests positive for CLDN6.

I am 18 years old or older.

Exclusion Criteria

I have previously received a CLDN6 targeting immune therapy.

I currently have active hepatitis B or C infection.

I have not used steroids or immunosuppressive drugs in the past 14 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive XmAb541 in combination with XmAb808 to evaluate safety, tolerability, and optimal dosing

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• XmAb541
• XmAb808

Trial Overview

The study is testing the safety and best dose of two new drugs, XmAb541 and XmAb808, given together to people with advanced cancers. Researchers will monitor how well patients tolerate these drugs and look at effects on tumor growth.

How Is the Trial Designed?

Group I: Dose Escalation and Dose Expansion of XmAb541 and XmAb808 Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Xencor, Inc.

Lead Sponsor

Trials

31

Recruited

2,500+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07593092

Phase 1, Safety and Tolerability Study of XmAb541 and ...

The primary purpose of this study is to determine whether the investigational drug XmAb541 in combination with XmAb808 is safe and well ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12592942/

Bispecific antibodies in the treatment of epithelial ovarian ...

In a phase I clinical study, 78 patients with recurrent ovarian cancer received ubamatamab at doses ranging from 0.3 to 800 mg without reaching ...

3.

oncpracticemanagement.com

oncpracticemanagement.com/web-exclusive-articles/combination-therapy-may-improve-outcomes-for-patients-with-ovarian-cancer

Combination Therapy May Improve Outcomes for Patients ...

The use of combination therapies in the first- and second-line settings for advanced ovarian cancer has the potential to improve patient outcomes.

4.

facingourrisk.org

facingourrisk.org/research-clinical-trials/results?amp%3Bintervention_type=risk%20reduction&amp%3Bstudy_type=prevention_detection_risk&cancer_type=ovarian&page=1

Research & Clinical Trials Search Results: Ovarian Cancer

This study is testing whether a new targeted therapy called AZD5335 works better than currently used treatments for people with platinum‑resistant ovarian, ...

5.

delta.larvol.com

delta.larvol.com/Products/?ProductId=a1dde8d1-9d9b-4efa-9117-8a147ddf46f6

XmAb541 / Xencor

New trial • P1 data • Endometrial Cancer • Germ Cell Tumors • Ovarian Cancer • Testicular Cancer ... XmAb541 in patients with ovarian cancer and other ...

6.

ctv.veeva.com

ctv.veeva.com/study/phase-1-safety-and-tolerability-study-of-xmab541-and-xmab808-in-advanced-solid-tumors

Phase 1, Safety and Tolerability Study of XmAb541 and ...

The primary purpose of this study is to determine whether the investigational drug XmAb541 in combination with XmAb808 is safe and well ...