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

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.

Stanford is currently accepting patients for this trial.

Intervention(s):

  • drug: CUE-102

Eligibility


Inclusion Criteria:

   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

      1. Histologically or cytologically documented adenocarcinoma of colon or rectum at
      the time of initial presentation

      2. Metastatic or locally advanced/unresectable disease

      3. 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)

      1. Histologically or cytologically documented gastric cancer at the time of initial
      presentation

      2. Metastatic or locally advanced/unresectable disease

      3. 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

      1. Histologically or cytologically documented pancreatic adenocarcinoma at the time
      of initial presentation

      2. Patients with metastatic or locally advanced/unresectable disease.

      3. 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

      1. Histologically or cytologically documented ovarian cancer at the time of initial
      presentation

      2. Metastatic or locally advanced/unresectable disease, with documented disease
      progression after last administration of standard therapies or intolerance to
      standard therapies.

      3. Prior systemic treatment must include a platinum-based regimen. (CUE-102 will be
      2nd line therapy or greater).

      4. 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).

   8. Patient must have HLA-A*0201 genotype as determined by genomic testing.

   9. Patient must have histologically and/or cytologically proven tumor(s) that is WT1
   positive.

10. Acceptable laboratory parameters.

11. 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.

12. 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.

13. 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.

Exclusion Criteria:

   1. Female patients who are pregnant or plan to become pregnant during the course of the
   trial

   2. Female patients who are breastfeeding

   3. Patients with symptomatic central nervous system (CNS) metastases must have been
   treated, be asymptomatic, and not have any of the following at the time of enrollment:

      1. Need for concurrent treatment for the CNS disease (e.g., surgery, radiation,
      corticosteroids >10 mg prednisone/day or equivalent)

      2. Progression of CNS metastases on CT or MRI for at least 28 days after last day of
      prior therapy for the CNS metastases

      3. Concurrent leptomeningeal disease or cord compression.

   4. Has an active autoimmune disease that has required systemic treatment in past 2 years
   (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive
   drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid
   replacement therapy for adrenal or pituitary insufficiency) is not considered a form
   of systemic treatment and is permitted.

   5. History of prior allogeneic bone marrow, stem-cell, or solid organ transplantation

   6. Treatment with any systemic anti-neoplastic therapy, or investigational therapy within
   the 14 days (or 28 days, for antibody drugs), before the first dose of CUE-102.

   7. Treatment with radiation therapy within 14 days before the first dose of CUE-102

   8. Treatment with corticosteroids (> 10 mg per day prednisone or equivalent) or other
   immune suppressive drugs within 14 days before the first dose of CUE-102. Steroids for
   topical, ophthalmic, inhaled, or nasal administration are permitted. Physiological
   replacement with up to a maximum dose of 5 mg equivalence of prednisone per day is
   permitted.

   9. History of clinically significant cardiovascular disease

10. Clinically significant pulmonary compromise (e.g., requirement for supplemental
   oxygen)

11. Clinically significant gastrointestinal (GI) disorders

12. Patients who experienced the following immune CPI-related AEs are ineligible even if
   the AE resolved to ≤ Grade 1 or baseline:

      1. ≥ Grade 3 ocular AE

      2. Changes in liver function tests that met the criteria for Hy's Law (> 3× ULN of
      either ALT/AST with concurrent > 2× ULN of total bilirubin (total and direct) and
      without alternate etiology)

      3. ≥ Grade 3 neurologic toxicity

      4. ≥ Grade 3 colitis

      5. ≥ Grade 3 renal toxicity

13. Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral
   treatment within 7 days before the first dose of CUE-102.

14. No known history of infection or positive test for HIV, Hepatitis B or Hepatitis C,
   testing prior to enrollment is not required unless mandated by local authority

15. Second primary invasive malignancy that has not been in remission for > 2 years.

16. History of trauma or major surgery within 28 days before the first dose of CUE-102

17. Any serious underlying medical or psychiatric condition that would impair the ability
   of the patient to receive or tolerate the planned treatment at the investigational
   site

18. Known hypersensitivity to recombinant proteins, polysorbate 80 or any excipient
   contained in the drug formulation for CUE-102

19. Vaccination with any live virus vaccine within 28 days before the first dose of
   CUE-102. Inactivated annual influenza vaccination is allowed.

20. Dementia or altered mental status that would preclude understanding and rendering of
   informed consent

21. Active or history of significant alcohol or other substance abuse within 1 year before
   the first dose of CUE-102

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Feriel Buchholz
650-721-4090
I'm interested

Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation,  mobile application development, and pharmaceutical trials.  

Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.