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XmAb20717 in Advanced Biliary Tract Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05297903
Recruitment Status : Recruiting
First Posted : March 28, 2022
Last Update Posted : November 21, 2022
Sponsor:
Collaborator:
Xencor, Inc.
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:
This is a single-arm, phase II clinical trial to evaluate the efficacy of XmAb20717 in patients with advanced biliary tract cancers who have progressed on, or were intolerant of, a gemcitabine-based chemotherapy regimen.

Condition or disease Intervention/treatment Phase
Biliary Tract Cancer Drug: XmAb20717 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of XmAb20717 in Patients With Advanced Biliary Tract Cancers
Actual Study Start Date : April 11, 2022
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: XmAb20717
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.
Drug: XmAb20717
10mg/kg IV
Other Name: ANTI-PD1 × ANTI-CTLA4 BISPECIFIC MONOCLONAL ANTIBODY




Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: From therapy initiation, assessed at each restaging scan, for up to 24 months ]
    Proportion of participants with the best response being complete response (CR) or partial response (PR)


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: From therapy initiation until progression or death, whichever comes first, for up to 60 months ]
    Time from study enrollment until disease progression or death with censoring for loss to follow up

  2. Overall survival [ Time Frame: From therapy initiation until death, for up to 60 months ]
    Time from study enrollment until death



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. Patients with tumors harboring an FGFR2 fusion, NTRK fusion, or IDH1 mutation must have received molecularly targeted therapy unless contraindicated or refused.
  3. ECOG performance status of 0 or 1.
  4. Measurable or evaluable disease as defined by RECIST v. 1.1.
  5. Available archival tissue or willingness to undergo biopsy during the screening period; this requirement can be waived if biopsy deemed infeasible or unsafe by the principal investigator.
  6. Must have adequate organ and hematopoietic function within 14 days of the start of study treatment.

Exclusion Criteria:

  1. Any concurrent condition requiring the continued or anticipated use of systemic steroids beyond physiologic replacement dosing (excluding non-systemic inhaled, topical skin, nasal, and/or ophthalmic corticosteroids). All other systemic corticosteroids above physiologic replacement dosing must be discontinued at least four weeks prior to first study treatment.
  2. Treatment with another investigational drug or other intervention within four weeks prior to the first study treatment date.
  3. Treatment with trans-arterial liver embolization, hepatic arterial infusion, or radiation doses of > 30 Gy within 4 weeks prior to the first study treatment date
  4. Treatment with chemotherapy within 3 weeks prior to the first study treatment date
  5. Prior treatment with a PD-1 inhibitor, PD-L1 inhibitor, or CTLA-4 inhibitor
  6. Known allergic reactions to study drug components.
  7. Active brain metastases. Patients with brain metastases must have stable neurological status following local therapy (surgery or radiation) for at least four weeks prior to first study treatment and must be off steroids related to the brain metastases for at least two weeks prior to study treatment.
  8. Active drug or alcohol use or dependence as documented in the chart that, in the opinion of the investigator, would interfere with adherence to study requirements.
  9. Active bacterial, viral, parasitic, or fungal infection requiring IV therapy within 2 weeks of the start of protocol treatment.
  10. A secondary primary malignancy that, in the judgment of the investigator, may affect the interpretation of results.
  11. Prior organ allograft or allogeneic bone marrow transplantation.
  12. A history of, or active, pneumonitis or interstitial lung disease.
  13. Active autoimmune disease. Patients with vitiligo, type 1 diabetes mellitus, endocrinopathies manageable by hormone replacement, and psoriasis not requiring systemic treatment are permitted to enroll. Other autoimmune conditions may be allowable at the discretion of the principal investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05297903


Contacts
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Contact: Jennifer Walsh 609-668-0689 Jennifer.Walsh4@pennmedicine.upenn.edu
Contact: Thomas Karasic, MD 215-614-1858 Thomas.Karasic@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
Abramson Cancer Center at University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jennifer Walsh    609-668-0689    Jennifer.Walsh4@pennmedicine.upenn.edu   
Contact: Thomas Karasic, MD    215-614-1858    Thomas.Karasic@pennmedicine.upenn.edu   
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Xencor, Inc.
Investigators
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Principal Investigator: Thomas Karasic, MD Abramson Cancer Center of the University of Pennsylvania
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT05297903    
Other Study ID Numbers: UPCC 17221
IRB#850515 ( Other Identifier: University of Pennsylvania IRB )
First Posted: March 28, 2022    Key Record Dates
Last Update Posted: November 21, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Biliary Tract Diseases
Digestive System Diseases
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs