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A Phase 1 in Patients With HLA-A*0201+ and WT1+ Recurrent/Metastatic Cancers

Status
Active
Cancer Type
Colon/Rectal Cancer
Ovarian Cancer
Pancreatic Cancer
Stomach/ Gastric Cancer
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT05360680
Protocol IDs
CUE-102-01 (primary)
NCI-2022-05169
Study Sponsor
Cue BioPharma

Summary

This is a Phase 1, open-label, 2-part, multi-center study evaluating the safety,
tolerability, PK, pharmacodynamics (PD), immunogenicity, and antitumor activity of CUE-102
intravenous (IV) monotherapy in HLA-A*0201 positive patients with WT1 positive
recurrent/metastatic solid tumors who have failed conventional therapies.

Objectives

CUE-102 is a novel fusion protein developed for the treatment of patients with WT1-positive
malignancies by selective engagement and expansion of tumor antigen-specific T cells that
should allow for increased potential for anti-cancer efficacy and reduced toxicity relative
to non-targeted forms of immunotherapy that result in systemic activation of the immune
system.

The goal of Part A is to characterize the safety, tolerability, and biological effects of
CUE-102.

The goal of Part B is to expand the safety and immune activity data at the RP2D identified in
Part A, and to evaluate antitumor activity at this dose.

Eligibility

  1. Ability to provide informed consent and documentation of informed consent prior to initiation of any study-related tests or procedures that are not part of standard of care for the patient's disease.
  2. Age =18 years old
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  4. Life expectancy =12 weeks
  5. Measurable disease as per RECIST 1.1 and documented by CT and/or MRI.
  6. All tumors must have histologically or cytologically confirmed cancer diagnosis
  7. Patients must have any of the following cancers to be eligible: A. Colorectal cancer
  8. Histologically or cytologically documented adenocarcinoma of colon or rectum at the time of initial presentation
  9. Metastatic or locally advanced/unresectable disease
  10. Documented disease progression after the last administration of standard therapies or intolerance to at least 2 prior systemic treatment regimens (CUE-102 will be 3rd line therapy or greater). B. Gastric cancer (including gastroesophageal junction)
  11. Histologically or cytologically documented gastric cancer at the time of initial presentation
  12. Metastatic or locally advanced/unresectable disease
  13. Documented disease progression after last administration of standard therapies or intolerance to standard therapies. (CUE-102 will be 2nd line therapy or greater). C. Pancreatic cancer
  14. Histologically or cytologically documented pancreatic adenocarcinoma at the time of initial presentation
  15. Patients with metastatic or locally advanced/unresectable disease.
  16. Prior systemic treatment must include either a fluoropyrimidine-based or gemcitabine-based regimen in either the (neo)adjuvant or relapsed setting. (CUE-102 will be 2nd line therapy or greater). D. Ovarian cancer
  17. Histologically or cytologically documented ovarian cancer at the time of initial presentation
  18. Metastatic or locally advanced/unresectable disease, with documented disease progression after last administration of standard therapies or intolerance to standard therapies.
  19. Prior systemic treatment must include a platinum-based regimen. (CUE-102 will be 2nd line therapy or greater).
  20. For patients determined to have platinum-sensitive disease, treatment with a second platinum-based combination regimen +/- bevacizumab should be considered prior to treatment with CUE-102 (CUE-102 will be 3rd line therapy or greater).
  21. Patient must have HLA-A*0201 genotype as determined by genomic testing.
  22. Patient must have histologically and/or cytologically proven tumor(s) that is WT1 positive.
  23. Acceptable laboratory parameters.
  24. Female patients of childbearing potential must agree to use acceptable contraceptive measures from the time of main study consent through 90 days after discontinuation of study drug administration.
  25. Non-vasectomized male patients with partners of childbearing potential must use barrier contraception from the time of main study consent through 90 days after discontinuation of study drug.
  26. Patients who have previously received an immune CPI (e.g., anti-programmed cell death ligand 1 (anti PD-L1), anti-programmed cell death 1 (anti-PD-1), anti-cytotoxic T lymphocyte-associated antigen 4 [CTLA-4]) prior to enrollment must have toxicities related to the CPI resolved to CTCAE = Grade 1 or baseline (level prior to the CPI) to be eligible for enrollment. Patients who have experienced CPI-related endocrinopathies (e.g., diabetes, adrenal insufficiency) may participate if endocrinopathies are controlled (CTCAE = Grade 1) with endocrinology support and appropriate repletion. Note: Patients who experienced previous hypothyroidism toxicity on a CPI are eligible to enter study regardless of CTCAE grade resolution as long as the patient is well controlled on thyroid replacement hormone.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

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