Carolina BioOncology Institute | Huntersville, NC
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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.
Full 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 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.
Enrollment
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Inclusion criteria
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
B. Gastric cancer (including gastroesophageal junction)
C. Pancreatic cancer
D. Ovarian cancer
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 criteria
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:
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:
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
Primary purpose
Allocation
Interventional model
Masking
52 participants in 5 patient groups
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Central trial contact
Steven Margossian, M.D., Ph.D.; Reena Lynam
Data sourced from clinicaltrials.gov
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