A Phase 1 in Patients With HLA-A*0201+ and WT1+ Recurrent/Metastatic Cancers
A Phase 1, Open-Label, Dose Escalation and Expansion Study of CUE-102 Monotherapy in HLA-A*0201 Positive Patients With WT1 Positive Recurrent/Metastatic Cancers
1 other identifier
interventional
42
1 country
15
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 in HLA-A\*0201 positive patients with WT1 positive recurrent/metastatic solid tumors who have failed conventional therapies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 colorectal-cancer
Started Jun 2022
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2022
CompletedFirst Posted
Study publicly available on registry
May 4, 2022
CompletedStudy Start
First participant enrolled
June 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2025
CompletedJanuary 22, 2026
January 1, 2026
2.7 years
April 19, 2022
January 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Dose Limiting Toxicity
Evaluate 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 Dose
Evaluate maximum tolerated dose (MTD) to establish a recommended Phase 2 dose (RP2D)
21 Days
Serum PK AUC for CUE-102
Area under the concentration-time curve (AUC) of CUE-102.
Up to 2 years
Serum PK Cmax for CUE-102
Maximum serum concentration (Cmax) of CUE-102.
Up to 2 years
Serum PK T1/2 for CUE-102
Terminal half-life (T1/2) of CUE-102.
Up to 2 years
Secondary Outcomes (8)
Safety and Tolerability of CUE-102 Assessed by NCI CTCAE v5.0
Up to 2 years
Antitumor Response Rate with Treatment of CUE-102
Up to 2 years
Antitumor Duration of Response with Treatment of CUE-102
Up to 2 years
Antitumor Clinical Benefit Rate with Treatment of CUE-102
Up to 2 years
Progression-Free Survival with Treatment of CUE-102
Up to 2 years
- +3 more secondary outcomes
Study Arms (5)
CUE-102 (1mg/kg) Dose Escalation
EXPERIMENTALCUE-102 (1 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years
CUE-102 (2 mg/kg) Dose Escalation
EXPERIMENTALCUE-102 (2 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years
CUE-102 (4 mg/kg) Dose Escalation
EXPERIMENTALCUE-102 (4 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years
CUE-102 (8 mg/kg) Dose Escalation
EXPERIMENTALCUE-102 (8 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years
CUE-102 Dose Expansion at Determined RP2D
EXPERIMENTALDose expansion of CUE-102 at determined RP2D Monotherapy IV infusion every 3 weeks for up to 2 years
Interventions
CUE-102 is a novel fusion protein developed for the treatment of patients with WT1-positive malignancies.
Eligibility Criteria
You may qualify if:
- 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).
- +15 more criteria
You may not qualify if:
- 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:
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cue Biopharmalead
Study Sites (15)
Mayo Clinic
Phoenix, Arizona, 85054, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Stanford Advanced Medicine Cancer Center
Palo Alto, California, 94304, United States
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Johns Hopkins University
Baltimore, Maryland, 21231, United States
Mayo Clinic - Rochester
Rochester, Minnesota, 55905, United States
Carol G. Simon Cancer Center - Morristown Medical Center
Morristown, New Jersey, 07960, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Carolina BioOncology Institute
Huntersville, North Carolina, 28078, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Cleveland Medical Center (University Hospitals)
Cleveland, Ohio, 44106, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405, United States
Carbone Cancer Center
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Matteo Levisetti, MD
Cue Biopharma
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2022
First Posted
May 4, 2022
Study Start
June 14, 2022
Primary Completion
March 12, 2025
Study Completion
March 12, 2025
Last Updated
January 22, 2026
Record last verified: 2026-01