CTX-009 + Standard Treatment for Biliary Tract Cancer
Recruiting in Palo Alto (17 mi)
Overseen byIan Hu, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: M.D. Anderson Cancer Center
Must not be taking: Antiplatelets, Anticoagulants
Disqualifiers: HIV, Active infection, Cardiovascular, others
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?To evaluate combination therapy of adding CTX-009 to the standard therapy GCD as first-line therapy in patients with unresectable or mBTC.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, you cannot take antiplatelet or anticoagulant drugs within 2 weeks before the trial or during it. It's best to discuss your specific medications with the trial team.
What makes the drug CTX-009 unique for treating biliary tract cancer?
CTX-009 is a novel treatment option for biliary tract cancer, which is an area where current standard chemotherapy has limited benefits. While the specific details of CTX-009's mechanism or administration are not provided, its investigation alongside standard treatment suggests it may offer a new approach or enhance existing therapies.
12345Eligibility Criteria
This trial is for patients with biliary tract cancers that cannot be removed by surgery or have spread. Participants must meet certain health standards, which are not specified here.Inclusion Criteria
Ability to understand and the willingness to sign a written informed consent document
I do not have any current infections.
I agree to use birth control during the study.
+7 more
Exclusion Criteria
I have recently used blood thinners.
I haven't had any major blood vessel problems in the last 6 months.
Hypersensitivity reactions to investigational product or similar drugs
+18 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Safety Lead-in
Participants receive CTX-009, Durvalumab, Gemcitabine, and Cisplatin to assess tolerability and determine the maximum tolerated dose
8 weeks
Weekly visits (outpatient)
Expansion
Participants continue receiving CTX-009, Durvalumab, Gemcitabine, and Cisplatin to evaluate efficacy and safety
6 months
Bi-weekly visits (outpatient)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests a new treatment combo: CTX-009 plus standard drugs Gemcitabine and Cisplatin, along with Durvalumab, to see if it's better as a first-line therapy for these cancer patients.
2Treatment groups
Experimental Treatment
Group I: Safety Lead-in: CTX-009+ Durvalumab+Gemcitabine+cisplatinExperimental Treatment4 Interventions
Participants will be administered treatment on an outpatient basis
Group II: Expansion: CTX-009+ Durvalumab+Gemcitabine+cisplatinExperimental Treatment4 Interventions
Participants will be administered treatment on an outpatient basis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
MD Anderson Cancer CenterHouston, TX
Loading ...
Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor
Compass Therapeutics, IncCollaborator
References
Prognostic relevance of carbohydrate antigen 19-9 levels in patients with advanced biliary tract cancer. [2022]Serum carbohydrate antigen 19-9 (CA 19-9) has been identified as biochemical marker for biliary tract cancer (BTC). The purpose of this study was to evaluate its value as a treatment response marker and its value as a prognostic parameter in patients with unresectable BTC. We analyzed 70 patients with BTC treated with chemotherapy. CA 19-9 levels before and after two treatment courses were analyzed with respect to their effect on treatment response. Patients were categorized into two subgroups according to biliary stenting: patients without endoscopic intervention or biliary drainage (non-stent subgroup) and patients with endoluminal stenting (stent subgroup). Pretreatment CA 19-9 levels were prognostic with respect to overall survival for the entire study population. Patients with CA 19-9 levels above the median of 300 units/mL had a nearly 3-fold risk for early death (hazard ratio, 2.92; 95% confidence interval, 1.51-5.64; adjusted P = 0.002) as compared with patients with CA 19-9 levels
The Prognostic Value of the CA19-9/TBIL Ratio in Patients with Biliary Tract Cancers (BTCs): A Retrospective Study. [2022]Incidence of biliary tract cancers (BTCs) in China is high, and surgery is the only curative option. Preoperative CA19-9 has been identified as a predictor for survival in patients with resectable BTCs, but more potential predictors need to be studied. This retrospective study aimed to establish the prognostic significance of CA19-9/TBIL ratio (CTR) in patients with BTCs.
Advances in the treatment of biliary tract cancers. [2021]To review new treatment and advances in biliary tract cancer (BTC).
Capecitabine plus cisplatin as first-line chemotherapy for advanced biliary tract cancer: a retrospective single-center study. [2015]Palliative chemotherapy is currently the primary therapeutic approach in the treatment of advanced biliary tract cancer (BTC). Our aim was to assess the efficacy and safety of capecitabine plus cisplatin as first-line chemotherapy for patients with advanced BTC and to analyze the relationship between the level of CA19-9 and clinical outcome.
Efficacy and Safety of Pembrolizumab in Patients with Refractory Advanced Biliary Tract Cancer: Tumor Proportion Score as a Potential Biomarker for Response. [2020]The current standard chemotherapy for advanced biliary tract cancer (BTC) has limited benefit, and novel therapies need to be investigated.