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Clinical Trial Record

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

2022-06-14

2025-03-12

2025-03-12

42

Study Overview

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.

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.

  • Colorectal Cancer
  • Gastric Cancer
  • Pancreatic Cancer
  • Ovarian Cancer
  • DRUG: CUE-102
  • CUE-102-01

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2022-04-19  

N/A  

2025-03-14  

2022-04-29  

N/A  

2025-03-18  

2022-05-04  

N/A  

2025-03  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: CUE-102 (1mg/kg) Dose Escalation

CUE-102 (1 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years

DRUG: CUE-102

  • CUE-102 is a novel fusion protein developed for the treatment of patients with WT1-positive malignancies.
EXPERIMENTAL: CUE-102 (2 mg/kg) Dose Escalation

CUE-102 (2 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years

DRUG: CUE-102

  • CUE-102 is a novel fusion protein developed for the treatment of patients with WT1-positive malignancies.
EXPERIMENTAL: CUE-102 (4 mg/kg) Dose Escalation

CUE-102 (4 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years

DRUG: CUE-102

  • CUE-102 is a novel fusion protein developed for the treatment of patients with WT1-positive malignancies.
EXPERIMENTAL: CUE-102 (8 mg/kg) Dose Escalation

CUE-102 (8 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years

DRUG: CUE-102

  • CUE-102 is a novel fusion protein developed for the treatment of patients with WT1-positive malignancies.
EXPERIMENTAL: CUE-102 Dose Expansion at Determined RP2D

Dose expansion of CUE-102 at determined RP2D Monotherapy IV infusion every 3 weeks for up to 2 years

DRUG: CUE-102

  • CUE-102 is a novel fusion protein developed for the treatment of patients with WT1-positive malignancies.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Dose Limiting ToxicityEvaluate dose-limiting toxicities (DLTs) during the first cycle of treatment with CUE-102, and to establish a recommended Phase 2 dose (RP2D)21 Days
Maximum Tolerated DoseEvaluate maximum tolerated dose (MTD) to establish a recommended Phase 2 dose (RP2D)21 Days
Serum PK AUC for CUE-102Area under the concentration-time curve (AUC) of CUE-102.Up to 2 years
Serum PK Cmax for CUE-102Maximum serum concentration (Cmax) of CUE-102.Up to 2 years
Serum PK T1/2 for CUE-102Terminal half-life (T1/2) of CUE-102.Up to 2 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Safety and Tolerability of CUE-102 Assessed by NCI CTCAE v5.0To evaluate safety and tolerability of CUE-102 using NCI CTCAE v5.0.Up to 2 years
Antitumor Response Rate with Treatment of CUE-102To evaluate antitumor response rate of CUE-102 by RECIST 1.1Up to 2 years
Antitumor Duration of Response with Treatment of CUE-102To evaluate antitumor duration of response of CUE-102 by RECIST 1.1Up to 2 years
Antitumor Clinical Benefit Rate with Treatment of CUE-102To evaluate antitumor clinical benefit rate of CUE-102 by RECIST 1.1Up to 2 years
Progression-Free Survival with Treatment of CUE-102To evaluate antitumor progression-free survival of CUE-102 by RECIST 1.1Up to 2 years
Overall Survival with Treatment of CUE-102To evaluate overall survival after treatment with CUE-102From First CUE-102 to Date of Death
Immune Response Assessed by WW1 Tetramer-Positive T cell LymphocytesTo evaluate the potential for immune response after treatment with CUE-102 using assessment of number of WT1 tetramer-positive T cell lymphocytes.Up to 2 years
Immune Response Assessed by CTL Markers of ActivationTo evaluate the potential for immune response after treatment with CUE-102 using assessment of cytotoxic T lymphocyte (CTL) markers of activationUp to 2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • STUDY_CHAIR: Matteo Levisetti, MD, Cue Biopharma

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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