Status and phase
Conditions
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Study type
Funder types
Identifiers
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
PART A (Dose Escalation Cohorts)
PART B (Dose Expansion Cohorts):
Melanoma
Renal cell carcinoma (clear cell predominant type)
Non-small cell lung carcinoma
Castrate-resistant adenocarcinoma of the prostate, defined as progressive disease after surgical castration, or progression in the setting of medical androgen ablation with a castrate level of testosterone (< 50 ng/dL)
Nasopharyngeal carcinoma
Cholangiocarcinoma
Basal cell carcinoma
Squamous cell carcinoma of the anus
Mesothelioma
Ovarian or fallopian tube carcinoma
Malignant adnexal neoplasms (including, but not limited to, sebaceous carcinoma, trichilemmal carcinoma, pilomatrix carcinoma, eccrine carcinoma, hidradenocarcinoma, adnexal carcinoma with divergent differentiation, papillary digital eccrine adenocarcinoma, microcystic adnexal carcinoma, and clear cell eccrine carcinoma)
Thymoma
Thymic carcinoma
Squamous cell carcinoma of the penis
Neuroendocrine carcinoma
Vulvar cancer
Non-squamous cell salivary gland carcinoma (except adenoid cystic carcinoma)
Subjects with other solid tumors for which there is published evidence of anti-tumor activity with anti-PD1/PDL1 and/or anti-CTLA4-directed therapy but for which there is no FDA-approved anti-PD1/PDL1 or CTLA4-directed checkpoint inhibitor treatment may be eligible for Part B after approval by the Medical Monitor.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
150 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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