A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
- Conditions
- Ampullary CancerGall Bladder CancerBiliary Tract CancerCholangiocarcinoma
- Interventions
- Registration Number
- NCT05506943
- Lead Sponsor
- Compass Therapeutics
- Brief Summary
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 treated, unresectable advanced or metastatic biliary tract cancers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 150
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CTX-009 plus Paclitaxel Paclitaxel - CTX-009 plus Paclitaxel CTX-009 - Paclitaxel Paclitaxel 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.
- Primary Outcome Measures
Name Time Method Best Overall Response From randomization to treatment discontinuation for any reason, average 6 months Percentage of patients whose Best Overall Response (BOR) is assessed as Complete Response (CR) or Partial Response (PR) as assessed by RECIST 1.1
- Secondary Outcome Measures
Name Time Method Overall Survival From randomization to death from any cause, average 12 months Time from randomization until the date of death by any cause. Patients who are still alive at the time of the analysis, or who have become lost to follow-up or withdrawn consent will be censored at their last date known to be alive
Disease Control Rate From randomization to treatment discontinuation for any reason, average 6 months Percentage of patients whose BOR is assessed as CR, PR, or Stable Disease (SD)
Duration of Response From first confirmed CR or PR to confirmed PD, average 6 months The time between the date of the radiological evaluation that first confirmed CR or PR and the date of the radiation evaluation that first confirmed Progressive Disease (PD)
Patient Reported Quality of Life From randomization to treatment discontinuation for any reason, average 6 months Assessed approximately every 2 months from patient reported data using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ)-C30 and BIL21
Exposure Response by Pharmacokinetic (PK) Sampling From C1D1 to treatment discontinuation for any reason, average of 6 months Serum concentrations of CTX-009 at specified timepoints
Progression Free Survival From randomization to first documented objective PD or death if PD does not occur, average 6 months Time from randomization until the date of objective PD (as assessed by RECIST 1.1) or the date of death (by any cause in the absence of disease progression)
Safety Profile of CTX-009 in Combination with Paclitaxel From randomization to 60 days after the last dose of study treatment, average 7 months Incidence of Treatment Emergent Adverse Events (TEAEs) and changes in clinical abnormalities for all randomized patients who received at least one dose of study treatment (either CTX-009 or paclitaxel)
Trial Locations
- Locations (34)
Mayo Clinic Arizona
🇺🇸Phoenix, Arizona, United States
University of Arizona
🇺🇸Tucson, Arizona, United States
University of Southern California Norris Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Stanford Medicine Cancer Center
🇺🇸Palo Alto, California, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Rocky Mountain Cancer Centers, LLP
🇺🇸Aurora, Colorado, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
AdventHealth Orlando
🇺🇸Orlando, Florida, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Scroll for more (24 remaining)Mayo Clinic Arizona🇺🇸Phoenix, Arizona, United States