A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors
Head and Neck Cancer
Skin Cancer (Non-Melanoma)
18 Years and older, Male and Female
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.
- Histologically or cytologically confirmed diagnosis of one of the following advanced solid tumors: PART A (Dose Escalation Cohorts)
- 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
- High-grade neuroendocrine carcinoma, including small cell carcinoma of the lung
- Cervical cancer;
- Squamous cell carcinoma of the anus PART B (Dose Expansion Cohorts):
- 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
- Basal cell carcinoma
- Squamous cell carcinoma of the anus
- 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)
- 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.
- All subjects' cancer must have progressed after treatment with all standard therapies or have no appropriate available therapies.
- Subjects, except those with adenocarcinoma of the prostate, must have measurable disease by RECIST 1.1.
- Have available adequate archival formalin-fixed paraffin-embedded block(s)/slides containing tumor or adequate pre-dose fresh tumor biopsy tissue
- ECOG performance status of 0 - 1
- Subjects with adenocarcinoma of the prostate must have evaluable disease (measurable or nonmeasurable lesions) by PCWG3.
Treatment Sites in Georgia
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