Study Summary
This trial is testing a new drug for people with biliary tract cancer who can't tolerate or haven't responded to gemcitabine-based chemotherapy.
Eligible Conditions
- Biliary Tract Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: From therapy initiation until death, for up to 60 months
Month 60
Overall survival
Month 60
Progression-free survival
Month 24
Objective Response Rate (ORR)
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Blinatumomab
100%Pyrexia
67%Blood immunoglobulin A decreased
62%Blood immunoglobulin G decreased
48%Hypokalaemia
48%Blood immunoglobulin M decreased
48%Headache
43%Chills
38%Oedema peripheral
38%Fatigue
33%Leukopenia
33%Weight increased
33%Nasopharyngitis
29%C-reactive protein increased
29%Lymphopenia
29%Thrombocytopenia
29%Back pain
24%Diarrhoea
24%Growing pains
24%Haematuria
24%Tremor
24%Nausea
24%Insomnia
24%Gamma-glutamyltransferase increased
24%Dyspnoea
24%Rash
24%Dizziness
24%Hypotension
19%Constipation
19%Alanine aminotransferase increased
19%Fibrin D dimer increased
19%Tachycardia
19%Hyperglycaemia
19%Periorbital oedema
19%Weight decreased
14%Vomiting
14%Cough
14%Hyperhidrosis
14%Blood potassium decreased
10%Cystitis
10%Sinusitis
10%Myalgia
10%Catheter site erythema
10%Anorexia
10%Bronchitis
10%Dry mouth
10%Pharyngitis
10%Immunoglobulins decreased
10%Catheter site pain
10%Blood alkaline phosphatase increased
10%Night sweats
10%Oral herpes
10%Neck pain
10%Coagulation factor XIII level increased
10%Lacrimation increased
10%Bradycardia
10%Immunodeficiency
10%Blood lactate dehydrogenase increased
10%Pain in extremity
10%Monocyte count increased
10%Arthralgia
10%Hypertension
5%Escherichia sepsis
5%Syncope
5%Medical device complication
5%Thrombosis in device
5%Bacterial sepsis
5%Epilepsy
5%Convulsion
5%Somnolence
5%Catheter related infection
5%Bronchopneumonia
Trial Design
1 Treatment Group
XmAb20717
1 of 1
Experimental Treatment
27 Total Participants · 1 Treatment Group
Primary Treatment: XmAb20717 · No Placebo Group · Phase 2
XmAb20717
Drug
Experimental Group · 1 Intervention: XmAb20717 · Intervention Types: DrugTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
XmAb20717
2018
Completed Phase 1
~150
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from therapy initiation until death, for up to 60 months
Who is running the clinical trial?
Xencor, Inc.Industry Sponsor
21 Previous Clinical Trials
2,210 Total Patients Enrolled
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
350 Previous Clinical Trials
105,041 Total Patients Enrolled
Thomas Karasic, MDPrincipal InvestigatorAbramson Cancer Center of the University of Pennsylvania
3 Previous Clinical Trials
18 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 6 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have no signs or symptoms of cancer.
You must have adequate organ and hematopoietic function within 14 days of the start of study treatment.
You have BTC and you have experienced progression, or intolerance of, systemic therapy with a gemcitabine-based regimen.
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Conditions
Cancer Related
Treatments