This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb20717, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb20717 in subjects with selected advanced solid tumors.
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||July 10, 2018||Phase 1||Interventional|
Primary Outcome 1 - Measure: Determine the safety and tolerability profile of XmAb20717
Primary Outcome 1 - Time Frame: 56 Days
- Histologically or cytologically confirmed diagnosis of advanced solid tumors
- Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2<br/> negative (triple-negative breast cancer; TNBC);
- Hepatocellular carcinoma;
- Urothelial carcinoma;
- Squamous cell carcinoma of the head and neck;
- Renal cell carcinoma (clear cell predominant type);
- Microsatellite instability-high or mismatch repair deficient colorectal carcinoma
or endometrial carcinoma;
- Non-small cell lung carcinoma;
- Gastric or gastroesophageal junction adenocarcinoma
- High-grade neuroendocrine carcinoma, including small cell carcinoma of the lung
- Cervical cancer;
- Squamous cell carcinoma of the anus
- All subjects' cancer must have progressed after treatment with standard therapies or
have no appropriate available therapies.
- Have available adequate archival formalin-fixed paraffin-embedded block(s)/slides
containing tumor or adequate pre-dose fresh tumor biopsy tissue
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Treatment with any CTLA4 antibody within 6 weeks of the start of study drug.
- Treatment with nivolumab or any PDL1 or PDL2-directed antibody within 4 weeks of the
start of study drug.
- Treatment with pembrolizumab within 4 - 12 weeks of the start of study drug (cohort
- Subjects currently receiving other anticancer therapies.
- Treatment with any other anticancer therapy within 2 weeks of the start of study drug
(i.e., other immunotherapy, chemotherapy, radiation therapy, etc.).
- A life-threatening (Grade 4) immune-mediated adverse event related to prior
- Failure to recover from any immune-related toxicity from prior cancer therapy to ≤
Grade 1, except if previous immune-related endocrinopathy is medically managed with
hormone replacement therapy only.
- Failure to recover from any other toxicity (other than immune-related toxicity)
related to previous anticancer treatment to ≤ Grade 2.
- Have known active CNS metastases and/or carcinomatous meningitis. Participants with
previously treated brain metastases may participate provided they are radiologically
stable, ie, are without evidence of progression for at least 4 weeks by repeat
imaging, are clinically stable, and without requirement of steroid treatment for at
least 14 days prior to first dose of study treatment.
- Active known or suspected autoimmune disease (except that subjects are permitted to
enroll if they have vitiligo; type 1 diabetes mellitus or residual hypothyroidism due
to an autoimmune condition that is treatable with hormone replacement therapy only;
psoriasis, atopic dermatitis, or another autoimmune skin condition that is managed
without systemic therapy; or arthritis that is managed without systemic therapy beyond
oral acetaminophen and non-steroidal anti-inflammatory drugs).
- Has any condition requiring systemic treatment with corticosteroids, prednisone
equivalents, or other immunosuppressive medications within 14 days prior to first dose
of study drug (except that inhaled or topical corticosteroids or brief courses of
corticosteroids given for prophylaxis of contrast dye allergic response are
- Receipt of an organ allograft.
- Treatment with antibiotics within 14 days prior to first dose of study drug.
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Barbara Hickingbottom, MD
Role: Study Director
Affiliation: Xencor, Inc.
Name: Barbara Hickingbottom, MD
|Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California 90048
|UCLA Hematology-Oncology Clinic (Westwood)
Los Angeles, California 90095
|University of California San Diego Moores Cancer Center
San Diego, California 92093-0698
|University of California San Francisco Medical Center
San Francisco, California 94115
Atlanta, Georgia 30322
|University of Chicago Medicine
Chicago, Illinois 60637
|The University of Kansas Clinical Research Center
Fairway, Kansas 66205
|Karmanos Cancer Institute
Detroit, Michigan 48201
|Columbia University Medical Center - Herbert Irving Pavilion
New York, New York 10032
|Providence Portland Medical Center
Portland, Oregon 97213
|Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania 19104
|The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
|Emily Couric Clinical Cancer Center
Charlottesville, Virginia 22903
|Seattle Cancer Care Alliance
Seattle, Washington 98109