CTX-009 + Paclitaxel for Biliary Tract Cancer

Not currently recruiting at 40 trial locations

Overseen By Patricia Gonzalez

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 2 & 3

Sponsor: Compass Therapeutics

Must not be taking: Anticoagulants, NSAIDs, Antiplatelets

Disqualifiers: Cardiovascular diseases, CNS metastasis, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination treatment for advanced biliary tract cancer that hasn't responded to initial treatments. The study compares the effects of the experimental drug CTX-009 combined with paclitaxel against paclitaxel alone. It aims to determine if the new combination more effectively slows or stops the cancer. Suitable participants have unresectable advanced or metastatic biliary tract cancer and have previously tried a treatment involving gemcitabine and platinum without success. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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 must not have taken chemotherapy, hormone therapy, anticancer immunotherapy, or investigational drugs within 2 weeks before starting the trial. Also, certain medications like full-dose anticoagulants, NSAIDs, and antiplatelets are not allowed close to the study treatment.

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

Research shows that CTX-009, combined with paclitaxel, has been studied for safety in treating patients with advanced or spreading biliary tract cancer. One study found that 37.5% of 24 patients responded positively to this combination, experiencing beneficial effects. The treatment's safety was also evaluated. Earlier studies have examined patient tolerance to CTX-009 with paclitaxel, helping researchers understand patient management and potential side effects.

Paclitaxel, a well-known chemotherapy drug, is already approved for treating various cancers, indicating general safety. Using it with CTX-009 in this trial builds on existing safety knowledge.

While specific side effects from these studies are not detailed here, the trial's advanced stage suggests sufficient evidence of safety to continue testing. As with any treatment, side effects can occur, so discussing potential risks with a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for biliary tract cancer?

CTX-009 is unique because it targets specific proteins involved in the growth of cancer cells, potentially offering a new mechanism of action compared to traditional chemotherapy. Unlike standard treatments for biliary tract cancer, which mainly involve conventional chemotherapy like gemcitabine and cisplatin, CTX-009 is a novel biologic agent designed to interfere with cancer cell signaling pathways. Researchers are excited about this treatment because it could provide a more targeted approach, potentially leading to better outcomes with fewer side effects. Additionally, the option to combine CTX-009 with paclitaxel might enhance its effectiveness by attacking the cancer from multiple angles.

What evidence suggests that this trial's treatments could be effective for biliary tract cancer?

Research has shown that combining CTX-009 with paclitaxel may help treat advanced biliary tract cancer. In a study with patients who had tried other treatments, this combination achieved a 37.5% overall response rate, meaning more than one-third of the patients experienced tumor shrinkage or disappearance. In this trial, participants will receive either the combination of CTX-009 plus paclitaxel or paclitaxel alone. Paclitaxel, a chemotherapy drug already used in cancer treatment, appears to work better when combined with CTX-009. These findings suggest that this combination could be more effective than using paclitaxel alone for people with this type of cancer. ^{1 2 6 7 8}

Who Is on the Research Team?

Minori Rosales, MD, PHD

Principal Investigator

Compass Therapeutics

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

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

My blood, liver, and kidney tests are normal.

Exclusion Criteria

It's been less than 4 weeks since my last surgery and less than 2 weeks since my last radiation therapy.

I have a history of bleeding disorders or stomach/intestinal diseases.

Patients with evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CTX-009 plus paclitaxel or paclitaxel alone, with the option to crossover after disease progression

6 months

Visits approximately every 2 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

7 months

Open-label extension (optional)

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• CTX-009
• Paclitaxel

Trial Overview

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.

How Is the Trial Designed?

Group I: CTX-009 plus Paclitaxel Experimental Treatment 2 Interventions

Group II: Paclitaxel Active Control 1 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.

Who Is Running the Clinical Trial?

Compass Therapeutics

Lead Sponsor

Trials

5

Recruited

430+

Published Research Related to This Trial

In a study of 34 patients with advanced biliary tract cancer, the combination of nab-paclitaxel, gemcitabine, and cisplatin resulted in a median progression-free survival of 7.1 months and overall survival of 16.4 months, indicating promising therapeutic potential.

The treatment was associated with significant adverse effects, particularly neutropenia and leukopenia in 26.5% of patients, while biomarkers like carcinoembryonic antigen (CEA) levels and immune cell changes were identified as potential indicators of treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Single-Arm Phase II Study of Nab-Paclitaxel Plus Gemcitabine and Cisplatin for Locally Advanced or Metastatic Biliary Tract Cancer. Liu, T., Li, Q., Lin, Z., et al.[2023]

In a study of 176 patients with advanced biliary tract cancer, the combination of capecitabine and cisplatin showed moderate efficacy, with a 17% partial response rate and a median overall survival of 7.4 months.

The study found that changes in CA19-9 levels were significantly correlated with both time-to-progression and overall survival, suggesting that CA19-9 could be a useful marker for monitoring treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Capecitabine plus cisplatin as first-line chemotherapy for advanced biliary tract cancer: a retrospective single-center study. Woo, SM., Lee, WJ., Han, SS., et al.[2015]

A phase I clinical trial of low-dose paclitaxel (PTX) as third-line palliative chemotherapy for patients with unresectable biliary tract cancer showed it was well-tolerated, with no severe adverse events (grade 3 or 4) reported.

The treatment resulted in a disease control rate of 83.3% and a median overall survival of 9.0 months, indicating that low-dose PTX is both safe and effective for patients who have not responded to previous therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I study of weekly palliative chemotherapy with low-dose third-line paclitaxel for biliary tract cancer. Tajima, H., Ohta, T., Shinbashi, H., et al.[2020]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05506943

A Study of CTX-009 in Combination With Paclitaxel in Adult ...

This is a multi-center, open-label, randomized, phase 2/3 trial of the bispecific antibody CTX-009 plus paclitaxel versus paclitaxel in patients with previously ...

2.

investors.compasstherapeutics.com

investors.compasstherapeutics.com/news-releases/news-release-details/compass-therapeutics-announces-phase-2-data-ctx-009-combination

News Release Details

CTX-009 in combination with paclitaxel demonstrated a 37.5% overall response rate (ORR) in 24 patients with BTC treated in the second- and ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11509068/

COMPANION-002 A clinical trial of investigational drug CTX ...

In a phase II study of patients with advanced biliary tract cancer who had received one or two prior therapies, CTX-009 with paclitaxel demonstrated a 37.5% ...

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dailynews.ascopubs.org

dailynews.ascopubs.org/do/responses-seen-advanced-biliary-tract-cancer-treated-ctx-009-plus-paclitaxel

Responses Seen in Advanced Biliary Tract Cancer Treated ...

A phase 2 study of CTX-009 combined with paclitaxel administered as second- or third-line therapy in patients with advanced biliary tract cancer ...

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tandfonline.com

tandfonline.com/doi/full/10.1080/14796694.2024.2351351

COMPANION-002 A clinical trial of investigational drug ...

A randomized phase II/III study, which will evaluate the safety and efficacy of CTX-009 in combination with paclitaxel versus paclitaxel alone as second-line ...

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ascopubs.org

ascopubs.org/doi/10.1200/JCO.2023.41.4_suppl.540

CTX-009 (ABL001), a bispecific antibody targeting DLL4 ...

A phase 1b study assessed the safety, tolerability, pharmacokinetics and efficacy of CTX-009 in combination with paclitaxel or irinotecan in ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38861293/

COMPANION-002 A clinical trial of investigational drug CTX ...

A randomized phase II/III study, which will evaluate the safety and efficacy of CTX-009 in combination with paclitaxel versus paclitaxel alone as second-line ...

8.

targetedonc.com

targetedonc.com/view/ctx-009-shows-preliminary-activity-safety-in-biliary-tract-cancer

CTX-009 Shows Preliminary Activity/Safety in Biliary Tract ...

Result announced in a press release by Compass Therapeutics, Inc revealed a 42% overall response rate consisting of 10 partial responses (PRs) ...