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Biliary Tract CancerPhase 2NCT05297903

XmAb20717 in Advanced Biliary Tract Cancers

A Phase 2 study testing XmAb20717 in people with Biliary Tract Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Biliary Tract Cancer
What is being tested?
XmAb20717
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteUnited States
Study dates
11 Apr 2022to 13 Jul 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of signed and dated informed consent form
  • Stated willingness to comply with all study procedures and availability for the duration of the study
  • Male or female, aged > 18 years of age
  • 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.
  • Patients with tumors harboring an FGFR2 fusion, NTRK fusion, or IDH1 mutation must have received molecularly targeted therapy unless contraindicated or refused. Patients without sequencing results for FGFR2 fusions, NTRK fusions, or IDH1 mutations at the time of screening are permitted to enroll in the study. If sequencing results demonstrating FGFR2 fusions, NTRK fusions, or IDH1 mutations become available after patients have enrolled on the study, patients will be informed of the results and available treatment options but may continue study treatment if they are deriving clinical benefit
  • ECOG performance status of 0 or 1.
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  • Measurable or evaluable disease as defined by RECIST v. 1.1.
  • 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.
  • For females of reproductive potential: Must have a negative serum pregnancy test performed within 7 days of first study treatment and must agree to use such a method during study participation and for an additional 3 months after the last study dose of XmAb20717. Reproductive potential is defined in section 8.2.11.
  • For males of reproductive potential with female partners of reproductive potential (per section 8.2.11): Must use of condoms or other methods to ensure effective contraception with partner during the study and for an additional 4 weeks after the end of XmAb20717 administration as outlined in section 8.2.11. Male subjects must agree not to donate sperm from screening through 4 weeks after completion of study
  • Must have adequate organ and hematopoietic function within 14 days of the start of study treatment as defined in Table 1. Labs from cycle 1 day 1 may be used for eligibility.

Who cannot join

  • 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.
  • Treatment with another investigational drug or other intervention within four weeks prior to the first study treatment date.
  • 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
  • Treatment with chemotherapy within 3 weeks prior to the first study treatment date
  • History of permanent discontinuation of a PD-1 or PD-L1 inhibitor therapy due to an immune related adverse event.
  • Prior treatment with a CTLA-4 inhibitor
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  • Pregnant or breastfeeding
  • Known allergic reactions to study drug components.
  • 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.
  • 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.
  • Active bacterial, viral, parasitic, or fungal infection requiring IV therapy within 2 weeks of the start of protocol treatment.
  • A secondary primary malignancy that, in the judgment of the investigator, may affect the interpretation of results.
  • Prior organ allograft or allogeneic bone marrow transplantation.
  • A history of, or active, pneumonitis or interstitial lung disease.
  • 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.
  • Receipt of a live-virus vaccine within 30 days prior to first dose of study drug (seasonal flu and COVID-19 vaccines are permitted, as long as they do not contain live virus and are not administered within 24 hours of planned administration of XmAb20717)
  • Known human immunodeficiency virus (HIV) infection with CD4+ T-cell (CD4+) counts < 350 cells/μL, or an HIV viral load greater than 400 copies/mL, or a history of an acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within the past 12 months, or who has not been on established antiretroviral therapy (ART) for at least 4 weeks prior to initiation of study drug dosing. (Effective ART is defined as a drug, dosage, and schedule associated with reduction and control of the viral load. HIV positive subjects who do not meet any of these exclusion criteria are eligible.)
  • Any serious or uncontrolled medical or psychiatric disorder that, in the opinion of the investigator, would prevent the patient from providing informed consent, may increase the risk associated with study participation or study drug administration, impair the ability of the patient to receive study protocol therapy, or interfere with the interpretation of the study results.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Abramson Cancer Center at University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Phase II Trial of XmAb20717 in Patients With Advanced Biliary Tract Cancers

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.

Being tested
XmAb20717
Medical subject headings
Biliary Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • XmAb20717Drug

    Also called ANTI-PD1 × ANTI-CTLA4 BISPECIFIC MONOCLONAL ANTIBODY

    10mg/kg IV

Study groups in NCT05297903
Study groupRoleWhat they receive
XmAb20717ExperimentalStudy 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.
Receives: Drug: XmAb20717

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    Proportion of participants with the best response being complete response (CR) or partial response (PR)

    Measured: From therapy initiation, assessed at each restaging scan, for up to 24 months

Secondary outcomes (4)

  1. Progression-free survival

    Time from study enrollment until disease progression or death with censoring for loss to follow up

    Measured: From therapy initiation until progression or death, whichever comes first, for up to 60 months

  2. Overall survival

    Time from study enrollment until death

    Measured: From therapy initiation until death, for up to 60 months

  3. Objective Response Rate (ORR) in patients that received prior immunotherapy

    Proportion of participants with the best response being complete response (CR) or partial who received prior immunotherapy.

    Measured: From therapy initiation, assessed at each restaging scan, for up to 24 months

  4. Objective Response Rate (ORR) in patients who did not received prior immunotherapy

    Proportion of participants with the best response being complete response (CR) or partial who did not receive prior immunotherapy.

    Measured: From therapy initiation, assessed at each restaging scan, for up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2022
  2. Study start11 Apr 2022
  3. Primary completion13 Jul 2026
  4. Study completion13 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05297903
Sponsor's protocol ID
UPCC 17221
Other IDs
IRB#850515
Status last verified
Sep 2026
First submitted
17 Feb 2022
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing XmAb20717 in people with Biliary Tract Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: From therapy initiation, assessed at each restaging scan, for up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05297903.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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