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A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)

Status
Active
Cancer Type
Head and Neck Cancer
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03752398
Protocol IDs
XmAb23104-01 (primary)
NCI-2019-00828
DUET-3
Study Sponsor
Xencor, Inc.

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.

Eligibility

  1. 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:
  2. Melanoma (excluding uveal melanoma)
  3. Cervical carcinoma
  4. Pancreatic carcinoma
  5. Breast carcinoma that is estrogen receptor, progesterone receptor, and Her2 negative
  6. Hepatocellular carcinoma
  7. Urothelial carcinoma
  8. Squamous cell carcinoma of the head and neck
  9. Nasopharyngeal carcinoma
  10. Renal cell carcinoma
  11. Colorectal carcinoma
  12. Endometrial carcinoma
  13. NSCLC
  14. Small cell lung cancer
  15. Gastric or gastroesophageal junction adenocarcinoma
  16. Sarcoma
  17. 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:
  18. Non-squamous NSCLC
  19. Melanoma
  20. HNSCC, including NPC
  21. CRC
  22. UPS, including other select high grade STS, such as MFS
  23. ccRCC Prior to enrolling into Part B (expansion), subjects should have received disease-specific standard therapy as indicated for:
  24. Non-squamous NSCLC
  25. Melanoma
  26. HNSCC, including NPC
  27. CRC
  28. UPS, including other select high-grade STS such as MFS
  29. RCC, clear cell histology (ccRCC)
  30. All subjects' cancer must have progressed after treatment with standard/approved therapies or have no appropriate available therapies.
  31. Subjects must have measurable disease by RECIST 1.1.
  32. All subjects must have adequate archival tumor sample (slides or archival FFPE block[s] containing tumor.
  33. 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.
  34. Subjects have an ECOG performance status of 0-1.

Treatment Sites in Georgia

Emory University Hospital - Atlanta


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

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