← Back to Search

Monoclonal Antibodies

XmAb20717 for Biliary Tract Cancer

Phase 2
Waitlist Available
Led By Thomas Karasic, MD
Research Sponsored by Abramson Cancer Center of the University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must have advanced biliary tract cancers (BTC) including intrahepatic, perihepatic, or extrahepatic cholangiocarcinoma or gallbladder carcinoma with histologic or cytologic confirmation who have experienced progression, or intolerance of, systemic therapy with a gemcitabine-based regimen.
ECOG performance status of 0 or 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from therapy initiation until death, for up to 60 months
Awards & highlights

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.

Who is the study for?
Adults over 18 with advanced biliary tract cancers, who've had progression or intolerance to gemcitabine-based therapy. They must be in relatively good health (ECOG status of 0 or 1), have measurable disease, and agree to contraception if of reproductive potential. Exclusions include recent use of certain cancer treatments, history of severe reactions to PD-1/PD-L1 inhibitors or CTLA-4 inhibitors, active infections requiring IV treatment, other serious medical conditions, and known HIV infection not well-controlled.Check my eligibility
What is being tested?
The trial is testing XmAb20717 for patients with advanced biliary tract cancers who haven't responded well to previous chemotherapy. It's a phase II study where all participants receive the same experimental drug without being compared to another treatment.See study design
What are the potential side effects?
While specific side effects for XmAb20717 are not listed here, similar drugs often cause immune-related reactions affecting various organs, infusion-related symptoms like fever or chills, fatigue, possible liver inflammation (hepatitis), skin rashes and could potentially worsen any pre-existing autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have advanced biliary tract cancer and cannot tolerate or didn't respond to gemcitabine-based treatment.
Select...
I am fully active or can carry out light work.
Select...
I have or haven't been treated for specific genetic changes in my tumor if they were found.
Select...
I am fully active or can carry out light work.
Select...
My advanced biliary tract cancer has worsened or didn't tolerate gemcitabine treatment.
Select...
I am willing and able to follow the study rules and attend all required visits.
Select...
I can provide tissue samples or am willing to have a biopsy if it's safe.
Select...
My blood and organ tests meet the study's requirements.
Select...
I am over 18 years old.
Select...
I agree to use effective contraception during the study and for 4 weeks after, and not to donate sperm.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from therapy initiation until death, for up to 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from therapy initiation until death, for up to 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
Objective Response Rate (ORR) in patients that received prior immunotherapy
Objective Response Rate (ORR) in patients who did not received prior immunotherapy
Overall survival
+1 more

Side effects data

From 2014 Phase 2 trial • 21 Patients • NCT00560794
100%
Pyrexia
67%
Blood immunoglobulin A decreased
62%
Blood immunoglobulin G decreased
48%
Hypokalaemia
48%
Blood immunoglobulin M decreased
48%
Headache
43%
Chills
38%
Fatigue
38%
Oedema peripheral
33%
Leukopenia
33%
Nasopharyngitis
33%
Weight increased
29%
Back pain
29%
Thrombocytopenia
29%
C-reactive protein increased
29%
Lymphopenia
24%
Diarrhoea
24%
Dizziness
24%
Haematuria
24%
Nausea
24%
Growing pains
24%
Gamma-glutamyltransferase increased
24%
Tremor
24%
Insomnia
24%
Dyspnoea
24%
Rash
24%
Hypotension
19%
Hyperglycaemia
19%
Constipation
19%
Alanine aminotransferase increased
19%
Fibrin D dimer increased
19%
Tachycardia
19%
Weight decreased
19%
Periorbital oedema
14%
Cough
14%
Vomiting
14%
Blood potassium decreased
14%
Hyperhidrosis
10%
Arthralgia
10%
Pain in extremity
10%
Neck pain
10%
Bradycardia
10%
Lacrimation increased
10%
Dry mouth
10%
Catheter site erythema
10%
Catheter site pain
10%
Bronchitis
10%
Cystitis
10%
Oral herpes
10%
Pharyngitis
10%
Sinusitis
10%
Blood alkaline phosphatase increased
10%
Monocyte count increased
10%
Myalgia
10%
Coagulation factor XIII level increased
10%
Immunoglobulins decreased
10%
Anorexia
10%
Immunodeficiency
10%
Blood lactate dehydrogenase increased
10%
Night sweats
10%
Hypertension
5%
Convulsion
5%
Somnolence
5%
Epilepsy
5%
Syncope
5%
Bacterial sepsis
5%
Bronchopneumonia
5%
Catheter related infection
5%
Escherichia sepsis
5%
Medical device complication
5%
Thrombosis in device
100%
80%
60%
40%
20%
0%
Study treatment Arm
Blinatumomab

Trial Design

1Treatment groups
Experimental Treatment
Group I: XmAb20717Experimental Treatment1 Intervention
Study participants will receive the recommended phase II dose (10mg/kg) of XmAb20717 by intravenous infusion on days 1 and 15 of a 28-day cycle for up to 2 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
XmAb20717
2018
Completed Phase 1
~150

Find a Location

Who is running the clinical trial?

Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
105,108 Total Patients Enrolled
Abramson Cancer Center at Penn MedicineLead Sponsor
383 Previous Clinical Trials
144,864 Total Patients Enrolled
Xencor, Inc.Industry Sponsor
29 Previous Clinical Trials
2,766 Total Patients Enrolled

Media Library

XmAb20717 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05297903 — Phase 2
Biliary Tract Cancer Research Study Groups: XmAb20717
Biliary Tract Cancer Clinical Trial 2023: XmAb20717 Highlights & Side Effects. Trial Name: NCT05297903 — Phase 2
XmAb20717 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05297903 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please rank XmAb20717 on a severity scale?

"While Phase 2 clinical trials offer some evidence of safety for XmAb20717, there is no data currently available to support its efficacy."

Answered by AI

Do we currently have room for more participants in this trial?

"The most recent information from clinicaltrials.gov shows that this trial is still looking for patients. The study was created on 4/11/2022 and, as of right now, 27 people are needed to participate at 1 location."

Answered by AI
~0 spots leftby Mar 2024