A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, M… (NCT05506943) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
United States168 participantsStarted 2023-01-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 18 years of age or older
✓. Histologically or cytologically confirmed unresectable advanced, metastatic, or recurrent biliary tract cancers (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampullary carcinoma)
✓. Patients must have radiologically documented progression after a prior gemcitabine and platinum containing chemotherapy regimen as first line therapy for locally advanced unresectable or metastatic disease.
✓. Patients who received perioperative treatment (adjuvant and neoadjuvant) may be eligible, as determined by the Sponsor Medical Monitor.
✓. Patients whose first line regimen was modified due to toxicity before disease progression, may be eligible, as determined by the Sponsor Medical Monitor.
✓. At least one lesion measurable as defined by RECIST v1.1
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
✓. Predicted life expectancy of at least 12 weeks
Exclusion criteria
✕. Patients who are eligible to be treated with a molecularly targeted therapy on a labelled regimen after receiving first-line chemotherapy. Patients who received a molecularly targeted therapy as part of their first line treatment may be eligible, as determined by the Sponsor Medical Monitor.
✕. From the time point of screening,
✕
What they're measuring
1
Best Overall Response
Timeframe: From randomization to treatment discontinuation for any reason, average 6 months