XmAb20717 in Advanced Biliary Tract Cancers
Study Details
Study Description
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 |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- Objective Response Rate (ORR) [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
- Progression-free survival [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
- Overall survival [From therapy initiation until death, for up to 60 months]
Time from study enrollment until death
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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.
-
ECOG performance status of 0 or 1.
-
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.
-
Must have adequate organ and hematopoietic function within 14 days of the start of study treatment.
Exclusion Criteria:
-
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
-
Prior treatment with a PD-1 inhibitor, PD-L1 inhibitor, or CTLA-4 inhibitor
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Abramson Cancer Center at University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Abramson Cancer Center of the University of Pennsylvania
- Xencor, Inc.
Investigators
- Principal Investigator: Thomas Karasic, MD, Abramson Cancer Center of the University of Pennsylvania
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UPCC 17221
- IRB#850515