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

Status
Active
Cancer Type
Anal Cancer
Gynecologic Cancers
Head and Neck Cancer
Lung Cancer
Mesothelioma
Penile Cancer
Skin Cancer (Non-Melanoma)
Unknown Primary
Uterine Cancer
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03517488
Protocol IDs
XmAb20717-01 (primary)
NCI-2018-00935
DUET-2
Study Sponsor
Xencor, Inc.

Summary

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.

Eligibility

  1. Histologically or cytologically confirmed diagnosis of one of the following advanced solid tumors: PART A (Dose Escalation Cohorts)
  2. Melanoma;
  3. Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2 negative (triple-negative breast cancer; TNBC);
  4. Hepatocellular carcinoma;
  5. Urothelial carcinoma;
  6. Squamous cell carcinoma of the head and neck;
  7. Renal cell carcinoma (clear cell predominant type);
  8. Microsatellite instability-high or mismatch repair deficient colorectal carcinoma or endometrial carcinoma;
  9. Non-small cell lung carcinoma;
  10. Gastric or gastroesophageal junction adenocarcinoma
  11. Mesothelioma;
  12. High-grade neuroendocrine carcinoma, including small cell carcinoma of the lung
  13. Cervical cancer;
  14. Squamous cell carcinoma of the anus PART B (Dose Expansion Cohorts):
  15. Melanoma
  16. Renal cell carcinoma (clear cell predominant type)
  17. Non-small cell lung carcinoma
  18. 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)
  19. Nasopharyngeal carcinoma
  20. Cholangiocarcinoma
  21. Basal cell carcinoma
  22. Squamous cell carcinoma of the anus
  23. Mesothelioma
  24. Ovarian or fallopian tube carcinoma
  25. 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)
  26. Thymoma
  27. Thymic carcinoma
  28. Squamous cell carcinoma of the penis
  29. Neuroendocrine carcinoma
  30. Vulvar cancer
  31. Non-squamous cell salivary gland carcinoma (except adenoid cystic carcinoma)
  32. 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.
  33. All subjects' cancer must have progressed after treatment with all standard therapies or have no appropriate available therapies.
  34. Subjects, except those with adenocarcinoma of the prostate, must have measurable disease by RECIST 1.1.
  35. Have available adequate archival formalin-fixed paraffin-embedded block(s)/slides containing tumor or adequate pre-dose fresh tumor biopsy tissue
  36. ECOG performance status of 0 - 1
  37. Subjects with adenocarcinoma of the prostate must have evaluable disease (measurable or nonmeasurable lesions) by PCWG3.

Treatment Sites in Georgia

Emory University Hospital - Atlanta


1364 Clifton Road NE
Atlanta, GA 30322
www.emoryhealthcare.org

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