A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3) (NCT03752398) | Clinical Trial Compass
CompletedPhase 1
A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)
United States198 participantsStarted 2019-05-01
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subjects in Part A (dose escalation) must have a diagnosis of any of the following:
✓. Melanoma (excluding uveal melanoma)
✓. Cervical carcinoma
✓. Pancreatic carcinoma
✓. Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2 negative
✓. Hepatocellular carcinoma
✓. Urothelial carcinoma
✓. Squamous cell carcinoma of the head and neck
Exclusion criteria
✕. 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.)
What they're measuring
1
Treatment-related adverse events as assessed by CTCAE v4.03
✕. 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