Breast Cancer Clinical Trial
A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)
This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb23104, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb23104 monotherapy and combination therapy with ipilimumab in subjects with selected advanced solid tumors.
Subjects in Part A (dose escalation) must have a diagnosis of any of the following:
Histologically or cytologically confirmed advanced solid tumors, including the following:
Melanoma (excluding uveal melanoma)
Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2 negative
Squamous cell carcinoma of the head and neck
Renal cell carcinoma
Small cell lung cancer
Gastric or gastroesophageal junction adenocarcinoma
Subjects in Part B (expansion) must have a diagnosis of any of the following:
Histologically or cytologically confirmed advanced solid tumors of the following types:
HNSCC, including NPC
UPS, including other select high grade STS, such as MFS
Prior to enrolling into Part B (expansion), subjects should have received disease-specific standard therapy as indicated for:
HNSCC, including NPC
UPS, including other select high-grade STS such as MFS
RCC, clear cell histology (ccRCC)
All subjects' cancer must have progressed after treatment with standard/approved therapies or have no appropriate available therapies.
Subjects must have measurable disease by RECIST 1.1.
All subjects must have adequate archival tumor sample (slides or archival FFPE block[s] containing tumor.
All subjects in Part B (dose expansion) must have a tumor lesion that can be biopsied at acceptable risk (in the judgment of the Investigator) and must agree to both a fresh biopsy during screening and a second biopsy following treatment.
Subjects have an ECOG performance status of 0-1.
Currently receiving other anticancer therapies
Prior treatment with an investigational anti-ICOS therapy
Treatment with any PDL1 or PDL2-directed therapy within 4 weeks of the start of study drug
Treatment with nivolumab within 4 weeks of the start of study drug
Treatment with pembrolizumab within 24 weeks of start of study drug for Cohorts 1A - 10A
Treatment with any other anticancer therapy within 2 weeks of the start of study drug (ie, other immunotherapy, chemotherapy, radiation therapy, etc.)
A life-threatening (Grade 4) irAE related to prior immunotherapy
Failure to recover from any irAE from prior cancer therapy to Grade ≤ 1, except for endocrinopathies that are on stable hormone replacement doses
Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anticancer treatment to Grade ≤ 2
Known active central nervous system involvement by malignant disease. Subjects 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 and 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
Receipt of an organ allograft
History or evidence of any other clinically unstable/uncontrolled disorder, condition, or disease (including, but not limited to, cardiopulmonary, renal, metabolic, hematologic or psychiatric) other than their primary malignancy, that in the opinion of the Investigator would pose a risk to patient safety or interfere with study evaluations, procedures, or completion
Treatment with antibiotics within 14 days prior to first dose of study drug
Receipt of a live-virus vaccine within 30 days prior to first dose of study drug (seasonal flu vaccines that do not contain live virus are permitted).
Treatment with ipilimumab within 4 weeks of the start of study drug
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There are 18 Locations for this study
San Diego California, 92093, United States
Aurora Colorado, 80045, United States
Denver Colorado, 80218, United States
Sarasota Florida, 34232, United States
Atlanta Georgia, 30322, United States
Iowa City Iowa, 52242, United States
Ann Arbor Michigan, 48109, United States
Saint Louis Missouri, 63110, United States
New York New York, 10032, United States
Durham North Carolina, 27710, United States
Portland Oregon, 97213, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15232, United States
Dallas Texas, 75230, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84112, United States
Charlottesville Virginia, 22903, United States
Seattle Washington, 98109, United States
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