Colorectal CancerPhase 1NCT05360680
A Phase 1 in Patients With HLA-A*0201+ and WT1+ Recurrent/Metastatic Cancers
A Phase 1 study testing CUE-102 in people with Colorectal Cancer and Gastric Cancer, run by Cue Biopharma at 15 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Gastric Cancer, Pancreatic Cancer
- What is being tested?
- CUE-102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 15 sitesUnited States
- Study dates
- 14 Jun 2022to 12 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Patients must have any of the following cancers to be eligible:
- 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).
- 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).
- 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).
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Winship Cancer Institute
Atlanta, Georgia, 30322
Johns Hopkins University
Baltimore, Maryland, 21231
Gabrail Cancer Center
Canton, Ohio, 44718
Cleveland Medical Center (University Hospitals)
Cleveland, Ohio, 44106
MD Anderson Cancer Center
Houston, Texas, 77030
Carolina BioOncology Institute
Huntersville, North Carolina, 28078
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Carbone Cancer Center
Madison, Wisconsin, 53792
Carol G. Simon Cancer Center - Morristown Medical Center
Morristown, New Jersey, 07960
Stanford Advanced Medicine Cancer Center
Palo Alto, California, 94304
Mayo Clinic
Phoenix, Arizona, 85054
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405
Moffitt Cancer Center
Tampa, Florida, 33612
Montefiore Medical Center
The Bronx, New York, 10461
About this study
Official title: 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
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.
Read the 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 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.
- Conditions
- Colorectal Cancer, Gastric Cancer, Pancreatic Cancer, Ovarian Cancer
- Being tested
- CUE-102
- Keywords
- Wilms' tumor 1, HLA A*0201
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms, Ovarian Neoplasms, Wilms Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CUE-102Drug
CUE-102 is a novel fusion protein developed for the treatment of patients with WT1-positive malignancies.
| Study group | Role | What they receive |
|---|---|---|
| CUE-102 (1mg/kg) Dose Escalation | Experimental | CUE-102 (1 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years Receives: Drug: CUE-102 |
| CUE-102 (2 mg/kg) Dose Escalation | Experimental | CUE-102 (2 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years Receives: Drug: CUE-102 |
| CUE-102 (4 mg/kg) Dose Escalation | Experimental | CUE-102 (4 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years Receives: Drug: CUE-102 |
| CUE-102 (8 mg/kg) Dose Escalation | Experimental | CUE-102 (8 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years Receives: Drug: CUE-102 |
| CUE-102 Dose Expansion at Determined RP2D | Experimental | Dose expansion of CUE-102 at determined RP2D Monotherapy IV infusion every 3 weeks for up to 2 years Receives: Drug: CUE-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 21 Days
Maximum Tolerated Dose
Evaluate maximum tolerated dose (MTD) to establish a recommended Phase 2 dose (RP2D)
Measured: 21 Days
Serum PK AUC for CUE-102
Area under the concentration-time curve (AUC) of CUE-102.
Measured: Up to 2 years
Serum PK Cmax for CUE-102
Maximum serum concentration (Cmax) of CUE-102.
Measured: Up to 2 years
Serum PK T1/2 for CUE-102
Terminal half-life (T1/2) of CUE-102.
Measured: Up to 2 years
Secondary outcomes (8)
Safety and Tolerability of CUE-102 Assessed by NCI CTCAE v5.0
To evaluate safety and tolerability of CUE-102 using NCI CTCAE v5.0.
Measured: Up to 2 years
Antitumor Response Rate with Treatment of CUE-102
To evaluate antitumor response rate of CUE-102 by RECIST 1.1
Measured: Up to 2 years
Antitumor Duration of Response with Treatment of CUE-102
To evaluate antitumor duration of response of CUE-102 by RECIST 1.1
Measured: Up to 2 years
Antitumor Clinical Benefit Rate with Treatment of CUE-102
To evaluate antitumor clinical benefit rate of CUE-102 by RECIST 1.1
Measured: Up to 2 years
Progression-Free Survival with Treatment of CUE-102
To evaluate antitumor progression-free survival of CUE-102 by RECIST 1.1
Measured: Up to 2 years
Overall Survival with Treatment of CUE-102
To evaluate overall survival after treatment with CUE-102
Measured: From First CUE-102 to Date of Death
Immune Response Assessed by WW1 Tetramer-Positive T cell Lymphocytes
To evaluate the potential for immune response after treatment with CUE-102 using assessment of number of WT1 tetramer-positive T cell lymphocytes.
Measured: Up to 2 years
Immune Response Assessed by CTL Markers of Activation
To evaluate the potential for immune response after treatment with CUE-102 using assessment of cytotoxic T lymphocyte (CTL) markers of activation
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start14 Jun 2022
- Primary completion12 Mar 2025
- Study completion12 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Phase 1 Dose Escalation and Expansion
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cue Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Matteo Levisetti, MD, Study chair, Cue Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360680
- Sponsor's protocol ID
- CUE-102-01
- Status last verified
- Jan 2026
- First submitted
- 19 Apr 2022
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05360680
- Acronym / sponsor ID
- CUE-102-01
- Conditions
- Colorectal Cancer, Gastric Cancer, Pancreatic Cancer, Ovarian Cancer
- Keywords
- Wilms' tumor 1, HLA A*0201
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cue BiopharmaIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 12 Mar 2025 (actual)
- Study completion
- 12 Mar 2025 (actual)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
- Model description
- Phase 1 Dose Escalation and Expansion
| Arm | Type | Receives |
|---|---|---|
| CUE-102 (1mg/kg) Dose Escalation | Experimental | Drug: CUE-102CUE-102 (1 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years |
| CUE-102 (2 mg/kg) Dose Escalation | Experimental | Drug: CUE-102CUE-102 (2 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years |
| CUE-102 (4 mg/kg) Dose Escalation | Experimental | Drug: CUE-102CUE-102 (4 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years |
| CUE-102 (8 mg/kg) Dose Escalation | Experimental | Drug: CUE-102CUE-102 (8 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years |
| CUE-102 Dose Expansion at Determined RP2D | Experimental | Drug: CUE-102Dose expansion of CUE-102 at determined RP2D Monotherapy IV infusion every 3 weeks for up to 2 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- 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.
Key exclusion criteria (29 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CUE-102CUE-102 is a novel fusion protein developed for the treatment of patients with WT1-positive malignancies. | Drug | CUE-102 (1mg/kg) Dose Escalation, CUE-102 (2 mg/kg) Dose Escalation, CUE-102 (4 mg/kg) Dose Escalation, CUE-102 (8 mg/kg) Dose Escalation, CUE-102 Dose Expansion at Determined RP2D |
Primary outcome
Dose Limiting Toxicity
Time frame: 21 Days
Evaluate dose-limiting toxicities (DLTs) during the first cycle of treatment with CUE-102, and to establish a recommended Phase 2 dose (RP2D)
Maximum Tolerated Dose
Time frame: 21 Days
Evaluate maximum tolerated dose (MTD) to establish a recommended Phase 2 dose (RP2D)
Serum PK AUC for CUE-102
Time frame: Up to 2 years
Area under the concentration-time curve (AUC) of CUE-102.
Serum PK Cmax for CUE-102
Time frame: Up to 2 years
Maximum serum concentration (Cmax) of CUE-102.
Serum PK T1/2 for CUE-102
Time frame: Up to 2 years
Terminal half-life (T1/2) of CUE-102.
8 secondary outcomes
Safety and Tolerability of CUE-102 Assessed by NCI CTCAE v5.0
Time frame: Up to 2 years
Antitumor Response Rate with Treatment of CUE-102
Time frame: Up to 2 years
Antitumor Duration of Response with Treatment of CUE-102
Time frame: Up to 2 years
Antitumor Clinical Benefit Rate with Treatment of CUE-102
Time frame: Up to 2 years
Progression-Free Survival with Treatment of CUE-102
Time frame: Up to 2 years
Overall Survival with Treatment of CUE-102
Time frame: From First CUE-102 to Date of Death
Immune Response Assessed by WW1 Tetramer-Positive T cell Lymphocytes
Time frame: Up to 2 years
Immune Response Assessed by CTL Markers of Activation
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matteo Levisetti, MD study chair
Cue Biopharma
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CUE-102 in people with Colorectal Cancer and Gastric Cancer, run by Cue Biopharma at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (time frame: 21 Days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.