A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors



Status:Recruiting
Conditions:Breast Cancer, Lung Cancer, Lung Cancer, Prostate Cancer, Colorectal Cancer, Skin Cancer, Cervical Cancer, Liver Cancer, Cancer, Cancer, Cancer, Women's Studies
Therapuetic Areas:Oncology, Reproductive
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:July 10, 2018
End Date:March 2021
Contact:Barbara Hickingbottom, MD
Email:bhickingbottom@xencor.com
Phone:858-480-3413

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A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®20717 in Subjects With Selected Advanced Solid Tumors

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.


Inclusion Criteria:

- Histologically or cytologically confirmed diagnosis of advanced solid tumors
including:

- Melanoma;

- Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2
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

- Mesothelioma;

- 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

Exclusion Criteria:

- 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
dependent).

- 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
immunotherapy.

- 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
permitted).

- Receipt of an organ allograft.

- Treatment with antibiotics within 14 days prior to first dose of study drug.
We found this trial at
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sites
Chicago, Illinois 60637
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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Charlottesville, Virginia 22903
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Detroit, Michigan 48201
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Los Angeles, California 90095
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505 Parnassus Ave
San Francisco, California 94143
(415) 476-1000
University of California, San Francisco Medical Center UCSF Medical Center is recognized throughout the world...
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