| Eligibility |
Inclusion Criteria:
1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the
duration of the study
3. Male or female, aged > 18 years of age
4. 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.
5. 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
6. ECOG performance status of 0 or 1.
7. Measurable or evaluable disease as defined by RECIST v. 1.1.
8. 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.
9. 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.
10. 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
11. 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.
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. History of permanent discontinuation of a PD-1 or PD-L1 inhibitor therapy due to an
immune related adverse event.
6. Prior treatment with a CTLA-4 inhibitor
7. Pregnant or breastfeeding
8. Known allergic reactions to study drug components.
9. 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.
10. 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.
11. Active bacterial, viral, parasitic, or fungal infection requiring IV therapy within 2
weeks of the start of protocol treatment.
12. A secondary primary malignancy that, in the judgment of the investigator, may affect
the interpretation of results.
13. Prior organ allograft or allogeneic bone marrow transplantation.
14. A history of, or active, pneumonitis or interstitial lung disease.
15. 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.
16. 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)
17. 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.)
18. 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.
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