What is the mechanism of action of this treatment?

The most common treatments for Biliary Tract Cancer include chemotherapy and targeted therapies, with emerging treatments focusing on immune checkpoint inhibitors like XmAb20717. XmAb20717 is a bispecific antibody that targets PD-1 and CTLA-4, two proteins that normally inhibit immune responses. By blocking these proteins, XmAb20717 enhances the immune system's ability to recognize and attack cancer cells. This is particularly important for Biliary Tract Cancer patients, as these cancers are often resistant to conventional therapies, and enhancing the immune response offers a promising new avenue for treatment.

What side effects are associated with this type of intervention?

Common treatments for Biliary Tract Cancer, particularly immunotherapies targeting PD-1 and CTLA-4 like nivolumab and ipilimumab, can lead to a range of side effects. These include immune-related adverse events such as fatigue, rash, diarrhea, and pruritus. More severe side effects can include pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis. The combination of these drugs can increase the frequency and severity of these immune-related side effects.

What prior FDA approvals exist?

As of now, there are no specific FDA approvals for bispecific antibodies targeting PD-1 and CTLA-4 in the treatment of biliary tract cancer. However, immunotherapy drugs like pembrolizumab (a PD-1 inhibitor) have shown efficacy in various cancers, including biliary tract cancers, in clinical trials. Pembrolizumab has been studied for its potential benefits in patients with advanced biliary tract cancers who have progressed on prior treatments. The ongoing research, including trials like XmAb20717, aims to explore the effectiveness of combining immune checkpoint inhibitors to enhance the immune response against these cancers.

What other types of research exist?

Promising alternatives to XmAb20717 for Biliary Tract Cancer patients include: 1) Durvalumab (anti-PD-L1) combined with Tremelimumab (anti-CTLA4) and paclitaxel, as studied in the IMMUNOBIL PRODIGE 57 phase II trial. 2) Dabrafenib plus Trametinib for patients with BRAFV600E mutations, as shown in the ROAR and NCI-MATCH trials. These treatments have demonstrated potential efficacy and safety in clinical trials for advanced BTC.

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Monoclonal Antibodies

XmAb20717 for Biliary Tract Cancer

Phase 2

Waitlist Available

Led By Thomas Karasic, MD

Research Sponsored by Abramson Cancer Center of the University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status of 0 or 1

Patient must have advanced biliary tract cancers (BTC) including intrahepatic, perihepatic, or extrahepatic cholangiocarcinoma or gallbladder carcinoma with histologic or cytologic confirmation who have experienced progression, or intolerance of, systemic therapy with a gemcitabine-based regimen.

Must not have

Active brain metastases. Patients with brain metastases must have stable neurological status following local therapy (surgery or radiation) for at least four weeks prior to first study treatment and must be off steroids related to the brain metastases for at least two weeks prior to study treatment

Active bacterial, viral, parasitic, or fungal infection requiring IV therapy within 2 weeks of the start of protocol treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from therapy initiation until death, for up to 60 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing XmAb20717, a drug that helps the immune system fight cancer, in patients with advanced biliary tract cancers. These patients have not responded to or cannot tolerate standard chemotherapy. The drug works by making the immune system better at finding and destroying cancer cells.

Who is the study for?

Adults over 18 with advanced biliary tract cancers, who've had progression or intolerance to gemcitabine-based therapy. They must be in relatively good health (ECOG status of 0 or 1), have measurable disease, and agree to contraception if of reproductive potential. Exclusions include recent use of certain cancer treatments, history of severe reactions to PD-1/PD-L1 inhibitors or CTLA-4 inhibitors, active infections requiring IV treatment, other serious medical conditions, and known HIV infection not well-controlled.

What is being tested?

The trial is testing XmAb20717 for patients with advanced biliary tract cancers who haven't responded well to previous chemotherapy. It's a phase II study where all participants receive the same experimental drug without being compared to another treatment.

What are the potential side effects?

While specific side effects for XmAb20717 are not listed here, similar drugs often cause immune-related reactions affecting various organs, infusion-related symptoms like fever or chills, fatigue, possible liver inflammation (hepatitis), skin rashes and could potentially worsen any pre-existing autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My advanced biliary tract cancer has worsened or didn't tolerate gemcitabine treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My brain cancer has not worsened for 4 weeks after treatment, and I haven't taken steroids for it in 2 weeks.

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I haven't had serious infections needing IV treatment in the last 2 weeks.

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I have had or currently have lung inflammation or scarring.

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I have been treated with a CTLA-4 inhibitor before.

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I have had an organ or bone marrow transplant from another person.

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I stopped taking a PD-1 or PD-L1 inhibitor due to a severe side effect.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from therapy initiation until death, for up to 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from therapy initiation until death, for up to 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and from therapy initiation until death, for up to 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR)

Secondary study objectives

Objective Response Rate (ORR) in patients that received prior immunotherapy

Objective Response Rate (ORR) in patients who did not received prior immunotherapy

Overall survival

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: XmAb20717Experimental Treatment1 Intervention

Study participants will receive the recommended phase II dose (10mg/kg) of XmAb20717 by intravenous infusion on days 1 and 15 of a 28-day cycle for up to 2 years.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

XmAb20717

2018

Completed Phase 1

~150

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Biliary Tract Cancer include chemotherapy and targeted therapies, with emerging treatments focusing on immune checkpoint inhibitors like XmAb20717. XmAb20717 is a bispecific antibody that targets PD-1 and CTLA-4, two proteins that normally inhibit immune responses. By blocking these proteins, XmAb20717 enhances the immune system's ability to recognize and attack cancer cells. This is particularly important for Biliary Tract Cancer patients, as these cancers are often resistant to conventional therapies, and enhancing the immune response offers a promising new avenue for treatment.