CTX-009 + Paclitaxel for Biliary Tract Cancer
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.12345Why 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.12678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CTX-009 plus paclitaxel or paclitaxel alone, with the option to crossover after disease progression
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
What Are the Treatments Tested in This Trial?
Interventions
- CTX-009
- Paclitaxel
Find a Clinic Near You
Who Is Running the Clinical Trial?
Compass Therapeutics
Lead Sponsor