CTX-009 + Paclitaxel for Biliary Tract Cancer

Recruiting at 38 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

150 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug CTX-009 + Paclitaxel for Biliary Tract Cancer?

A study on low-dose paclitaxel (a component of the treatment) showed it was safe and effective for patients with advanced biliary tract cancer, with a disease control rate of 83.3% and a median survival of 9 months. Additionally, second-line chemotherapy, which includes drugs like paclitaxel, has been associated with improved survival compared to supportive care alone. ^{1 2 3 4 5}

Is the combination of CTX-009 and Paclitaxel safe for humans?

Paclitaxel, used in various forms, has been shown to be generally safe in humans for treating biliary tract cancer, with low-dose treatments being well-tolerated and not causing severe side effects in some studies. ^{3 4 6 7 8}

What makes the drug CTX-009 + Paclitaxel unique for treating biliary tract cancer?

CTX-009 combined with Paclitaxel is unique because it explores a novel combination of treatments for biliary tract cancer, which is a rare and aggressive disease with limited effective options. While Paclitaxel has been used in other regimens, the addition of CTX-009 may offer a new approach to improve outcomes for patients with this challenging condition. ^{2 3 8 9 10}

What is the purpose of this trial?

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.

Research Team

Minori Rosales, MD, PHD

Principal Investigator

Compass Therapeutics

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Horizons on the Therapy of Biliary Tract Cancers: A State-of-the-art Review. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Cetuximab, gemcitabine and capecitabine in patients with inoperable biliary tract cancer: a phase 2 study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Phase I study of weekly palliative chemotherapy with low-dose third-line paclitaxel for biliary tract cancer. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Benefit of second-line systemic chemotherapy for advanced biliary tract cancer: A propensity score analysis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Second-line chemotherapy for advanced biliary tract cancer after failure of the gemcitabine-platinum combination: A large multicenter study by the Association des Gastro-Entérologues Oncologues. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Second-line chemotherapy in patients with advanced or recurrent biliary tract cancer: a single center, retrospective analysis of 294 cases. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Porcine feasibility and safety study of a new paclitaxel-eluting biliary stent with a Pluronic-containing membrane. [2022]

8. Korea (South) 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. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Capecitabine plus cisplatin as first-line chemotherapy for advanced biliary tract cancer: a retrospective single-center study. [2015]

10. England pubmed.ncbi.nlm.nih.gov

Sintilimab plus nab-paclitaxel as second-line treatment for advanced biliary tract cancer: study protocol for an investigator-initiated phase 2 trial (NapaSinti trial). [2023]