What is the mechanism of action of this treatment?

Common treatments for Biliary Tract Cancer (BTC) include bispecific antibodies like CTX-009 and microtubule stabilizers like paclitaxel. Bispecific antibodies target two different antigens or pathways, enhancing the immune system's ability to recognize and attack cancer cells. Paclitaxel inhibits cell division by stabilizing microtubules, causing cell cycle arrest and apoptosis in rapidly dividing cancer cells. This combination aims to improve treatment efficacy by simultaneously enhancing immune targeting and disrupting cancer cell proliferation, which is crucial for BTC patients.

What side effects are associated with this type of intervention?

Common treatments for biliary tract cancer include chemotherapy agents like paclitaxel and investigational therapies such as bispecific antibodies. Paclitaxel, a microtubule stabilizer, is known to cause side effects such as neutropenia, neuropathy, fatigue, and alopecia. Bispecific antibodies, which target two antigens or pathways, can lead to immune-related adverse effects, including cytokine release syndrome, infusion reactions, and potential organ-specific toxicities. Combining these treatments may result in a compounded risk of these side effects, necessitating careful monitoring and management.

What prior FDA approvals exist?

Currently, there are no specific FDA approvals for the combination of a bispecific antibody and paclitaxel for the treatment of Biliary Tract Cancer. However, treatments involving paclitaxel, a microtubule stabilizer, have been explored in clinical settings. The trial CTX-009 plus paclitaxel is investigating a novel approach by combining a bispecific antibody with paclitaxel, aiming to target multiple pathways involved in cancer progression. This combination represents an innovative strategy in the treatment landscape of Biliary Tract Cancer.

What other types of research exist?

Promising novel alternatives for Biliary Tract Cancer patients in 2024 include: 1) Pemigatinib, an FGFR inhibitor, for patients with FGFR2 fusions or rearrangements. 2) Immunotherapy options such as Pembrolizumab or Nivolumab, especially for patients with high PD-L1 expression. 3) Combination therapies like Copanlisib (a PI3K inhibitor) plus Gemcitabine and Cisplatin, which are being evaluated in clinical trials. These alternatives offer different mechanisms of action and have shown potential in recent studies.

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Monoclonal Antibodies

CTX-009 + Paclitaxel for Biliary Tract Cancer

Phase 2 & 3

Recruiting

Research Sponsored by Compass Therapeutics

Eligibility Criteria Checklist

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

Must have

18 years of age or older

Histologically or cytologically confirmed unresectable advanced, metastatic, or recurrent biliary tract cancers (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampullary carcinoma)

Timeline

Screening 3 days

Treatment Varies

Follow Up 3 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug (CTX-009) combined with chemotherapy in patients with advanced biliary tract cancers who have already had other treatments and cannot have surgery. The treatment aims to boost the immune system and stop cancer cell growth.

Who is the study for?

Adults over 18 with advanced, metastatic or recurrent biliary tract cancers including gallbladder and ampullary cancer. They must have had previous chemotherapy, be in good physical condition (ECOG 0-1), and not be at risk of bleeding. Women must use birth control and men should too if they're not sterile.

What is being tested?

The trial is testing CTX-009 combined with Paclitaxel against Paclitaxel alone in patients who've already been treated for their cancer. It's an open-label study where everyone knows what treatment they're getting, and it's randomized to compare the results fairly.

What are the potential side effects?

Possible side effects include those common to antibody treatments like allergic reactions, as well as those associated with chemotherapy such as nausea, hair loss, nerve damage, muscle aches, low blood cell counts increasing infection risk.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My cancer is in the bile ducts and cannot be removed by surgery.

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My cancer progressed after initial treatment with gemcitabine and platinum.

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I am fully active or can carry out light work.

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Your doctor believes you are likely to live for at least 12 more weeks.

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I had a procedure to drain my bile duct at least 1 week ago.

Timeline

Screening ~ 3 days1 visit

Treatment ~ Varies

Follow Up ~ 3 days1 visit

Screening ~ 3 days

Treatment ~ Varies

Follow Up ~3 days

This trial's timeline: 3 days for screening, Varies for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Best Overall Response

Secondary study objectives

Disease Control Rate

Duration of Response

Exposure Response by Pharmacokinetic (PK) Sampling

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CTX-009 plus PaclitaxelExperimental Treatment2 Interventions

Group II: PaclitaxelActive Control1 Intervention

Patients randomized to receive paclitaxel only have the option to crossover to the CTX-009 plus paclitaxel arm after documented disease progression per RECIST v1.1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5450

0 / 6Eligibility 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

Common treatments for Biliary Tract Cancer (BTC) include bispecific antibodies like CTX-009 and microtubule stabilizers like paclitaxel. Bispecific antibodies target two different antigens or pathways, enhancing the immune system's ability to recognize and attack cancer cells. Paclitaxel inhibits cell division by stabilizing microtubules, causing cell cycle arrest and apoptosis in rapidly dividing cancer cells. This combination aims to improve treatment efficacy by simultaneously enhancing immune targeting and disrupting cancer cell proliferation, which is crucial for BTC patients.

Albumin-bound paclitaxel as new treatment for metastatic cholangiocarcinoma: A case report.