Status:
COMPLETED
A Phase 1 in Patients With HLA-A*0201+ and WT1+ Recurrent/Metastatic Cancers
Lead Sponsor:
Cue Biopharma
Conditions:
Colorectal Cancer
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Detailed Description
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 i...
Eligibility Criteria
Inclusion
- 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.
- Age ≥18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy ≥12 weeks
- Measurable disease as per RECIST 1.1 and documented by CT and/or MRI.
- All tumors must have histologically or cytologically confirmed cancer diagnosis
- Patients must have any of the following cancers to be eligible:
- A. Colorectal cancer
- Histologically or cytologically documented adenocarcinoma of colon or rectum at the time of initial presentation
- Metastatic or locally advanced/unresectable disease
- 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)
- Histologically or cytologically documented gastric cancer at the time of initial presentation
- Metastatic or locally advanced/unresectable disease
- 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
- Histologically or cytologically documented pancreatic adenocarcinoma at the time of initial presentation
- Patients with metastatic or locally advanced/unresectable disease.
- 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
- Histologically or cytologically documented ovarian cancer at the time of initial presentation
- Metastatic or locally advanced/unresectable disease, with documented disease progression after last administration of standard therapies or intolerance to standard therapies.
- Prior systemic treatment must include a platinum-based regimen. (CUE-102 will be 2nd line therapy or greater).
- 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).
- Patient must have HLA-A\*0201 genotype as determined by genomic testing.
- Patient must have histologically and/or cytologically proven tumor(s) that is WT1 positive.
- Acceptable laboratory parameters.
- 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.
- 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.
- 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
- Female patients who are pregnant or plan to become pregnant during the course of the trial
- Female patients who are breastfeeding
- 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:
- Need for concurrent treatment for the CNS disease (e.g., surgery, radiation, corticosteroids \>10 mg prednisone/day or equivalent)
- Progression of CNS metastases on CT or MRI for at least 28 days after last day of prior therapy for the CNS metastases
- Concurrent leptomeningeal disease or cord compression.
- 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.
- History of prior allogeneic bone marrow, stem-cell, or solid organ transplantation
- 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.
- Treatment with radiation therapy within 14 days before the first dose of CUE-102
- 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.
- History of clinically significant cardiovascular disease
- Clinically significant pulmonary compromise (e.g., requirement for supplemental oxygen)
- Clinically significant gastrointestinal (GI) disorders
- Patients who experienced the following immune CPI-related AEs are ineligible even if the AE resolved to ≤ Grade 1 or baseline:
- ≥ Grade 3 ocular AE
- 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)
- ≥ Grade 3 neurologic toxicity
- ≥ Grade 3 colitis
- ≥ Grade 3 renal toxicity
- Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days before the first dose of CUE-102.
- 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
- Second primary invasive malignancy that has not been in remission for \> 2 years.
- History of trauma or major surgery within 28 days before the first dose of CUE-102
- 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
- Known hypersensitivity to recombinant proteins, polysorbate 80 or any excipient contained in the drug formulation for CUE-102
- Vaccination with any live virus vaccine within 28 days before the first dose of CUE-102. Inactivated annual influenza vaccination is allowed.
- Dementia or altered mental status that would preclude understanding and rendering of informed consent
- Active or history of significant alcohol or other substance abuse within 1 year before the first dose of CUE-102
Key Trial Info
Start Date :
June 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2025
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT05360680
Start Date
June 14 2022
End Date
March 12 2025
Last Update
March 18 2025
Active Locations (15)
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1
Mayo Clinic
Phoenix, Arizona, United States, 85054
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
Stanford Advanced Medicine Cancer Center
Palo Alto, California, United States, 94304
4
Moffitt Cancer Center
Tampa, Florida, United States, 33612