95 Participants Needed

XmAb®819 for Renal Cell Carcinoma

Recruiting at 9 trial locations
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SL
GB
LF
CB
Overseen ByChet Bohac, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests XmAb®819, a new drug for kidney cancer patients whose disease has returned or resisted other treatments. It checks if the drug is safe, how the body handles it, and its potential to reduce tumors.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had systemic cancer treatment within a certain period before starting the trial, so you may need to discuss this with the trial team.

What safety data exists for XmAb®819 or similar bispecific antibodies in humans?

In a study involving a bispecific antibody similar to XmAb®819, some patients experienced temporary side effects like leukopenia (a drop in white blood cells) and elevated levels of certain proteins in the blood after treatment. The maximum tolerated dose was identified, indicating careful monitoring is needed during treatment.12345

What makes the drug XmAb819 unique for treating renal cell carcinoma?

XmAb819 is a bispecific antibody that targets both ENPP3 on tumor cells and CD3 on T-cells, which helps direct the body's immune system to attack the cancer cells. This dual-targeting approach is different from traditional treatments that typically focus on a single target, potentially enhancing the immune response against the tumor.13456

What data supports the effectiveness of the drug XmAb819 for treating renal cell carcinoma?

Research on similar bispecific antibodies, like the A2V CrossMab, shows that targeting two pathways can significantly reduce tumor size and improve treatment outcomes in renal cell carcinoma. Additionally, bispecific antibodies targeting CD3 have been shown to effectively direct immune cells to attack cancer cells, suggesting potential for XmAb819.14578

Who Is on the Research Team?

CB

Chet Bohac, MD

Principal Investigator

Xencor, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with advanced clear cell renal cell carcinoma who have seen their cancer return or not respond to standard treatments. They must be relatively healthy (ECOG status 0 or 1), have a tumor sample available, and measurable disease. People can't join if they've had certain recent cancers, brain metastases, serious allergies to monoclonal antibodies, autoimmune diseases, or significant infections recently.

Inclusion Criteria

My cancer can be measured by scans and has grown in previously treated areas.
I am fully active or can carry out light work.
My kidney cancer has returned and worsened despite treatment.
See 1 more

Exclusion Criteria

I have another cancer that is getting worse or was treated in the last 2 years.
I have an autoimmune disease but it's either vitiligo, type 1 diabetes, manageable thyroid issues, skin conditions not needing systemic treatment, or arthritis treated without strong medication.
I haven't taken cancer drugs within a period before starting the study treatment.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Part A)

Establish the dosing schedule for XmAb819 administered IV and SC, including priming and step-up doses

8 weeks
Weekly visits for dose adjustments and monitoring

Dose Expansion (Part B)

Administer XmAb819 IV or SC to further evaluate safety, tolerability, and preliminary antitumor activity

8 weeks
Bi-weekly visits for treatment and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • XmAb819
Trial Overview The study tests XmAb®819 given through IV or SC injections in patients with relapsed/refractory kidney cancer. It aims to find the safest and most effective dose that shows biological activity against the cancer.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Dose Escalation and ExpansionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Xencor, Inc.

Lead Sponsor

Trials
31
Recruited
2,500+

Published Research Related to This Trial

The study developed an effective pretargeting strategy for renal cell carcinoma (RCC) using a bispecific monoclonal antibody (bsMAb), which showed high tumor uptake of a radiolabeled peptide compared to other methods.
Optimal conditions for the pretargeting strategy were identified, with a 72-hour interval for the bsMAb IgG and a 4-hour interval for the bsMAb F(ab')(2), demonstrating that both forms of the bsMAb can achieve efficient tumor targeting without affecting the retention of the radiolabel.
Comparison of IgG and F(ab')2 fragments of bispecific anti-RCCxanti-DTIn-1 antibody for pretargeting purposes.van Schaijk, FG., Boerman, OC., Soede, AC., et al.[2018]
The novel bispecific antibody A2V CrossMab, targeting both Angiopoietin-2 and VEGF, significantly reduced tumor volume and vessel density in renal cell carcinoma compared to treatments targeting either factor alone.
A2V CrossMab also led to a significant down-regulation of angiogenesis-related genes, indicating its potential for enhanced anti-tumor efficacy in RCC treatment.
Effect of Ang-2-VEGF-A Bispecific Antibody in Renal Cell Carcinoma.Bessho, H., Wong, B., Huang, D., et al.[2015]
The bispecific antibody construct (bAb) targeting both CD3 and EGFR effectively induced significant cell lysis in EGFR-positive tumor cells at very low concentrations (1 ng/ml), demonstrating its potential efficacy in targeting cancer cells.
However, the bAb also caused lysis of normal cells expressing EGFR, indicating a need for careful consideration of safety in future clinical trials, as it may affect healthy tissues alongside tumor cells.
Induction of tumour cell lysis by a bispecific antibody recognising epidermal growth factor receptor (EGFR) and CD3.Knuth, A., Bernhard, H., Jäger, E., et al.[2019]

Citations

Comparison of IgG and F(ab')2 fragments of bispecific anti-RCCxanti-DTIn-1 antibody for pretargeting purposes. [2018]
Effect of Ang-2-VEGF-A Bispecific Antibody in Renal Cell Carcinoma. [2015]
Induction of tumour cell lysis by a bispecific antibody recognising epidermal growth factor receptor (EGFR) and CD3. [2019]
Therapeutic advantage of pretargeted radioimmunotherapy using a recombinant bispecific antibody in a human colon cancer xenograft. [2006]
Bispecific monoclonal antibodies for intravenous treatment of carcinoma patients: immunobiologic aspects. [2016]
Development of an imaging-guided CEA-pretargeted radionuclide treatment of advanced colorectal cancer: first clinical results. [2022]
Tumour targeting of the anti-ovarian carcinoma x anti-CD3/TCR bispesific monoclonal antibody OC/TR and its parental MOv18 antibody in experimental ovarian cancer. [2015]
Localization of monoclonal antibody G250 and bispecific monoclonal antibody CD3/G250 in human renal-cell carcinoma xenografts: relative effects of size and affinity. [2019]
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