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Cancer Vaccine

CUE-102 for Cancer

Phase 1
Recruiting
Research Sponsored by Cue Biopharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Patient must have HLA-A*0201 genotype as determined by genomic testing
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective.

Who is the study for?
This trial is for adults (18+) with specific advanced cancers (ovarian, colorectal, stomach, pancreatic) that have worsened despite treatment. Participants must be HLA-A*0201 positive and WT1 positive, have an ECOG performance status of 0 or 1, a life expectancy of at least 12 weeks, measurable disease by CT/MRI scans, and acceptable organ function. They should not be pregnant/breastfeeding and must agree to contraception.Check my eligibility
What is being tested?
The study tests CUE-102 as a monotherapy given intravenously to patients with recurrent/metastatic solid tumors expressing WT1 protein. It's in Phase 1 where safety, tolerability, how the body processes the drug (pharmacokinetics), its effects on the body (pharmacodynamics), immune response it generates (immunogenicity), and its ability to fight cancer are evaluated.See study design
What are the potential side effects?
Potential side effects of CUE-102 are not detailed but may include typical reactions related to immunotherapies such as infusion-related reactions; flu-like symptoms including fever and chills; fatigue; possible autoimmune responses due to immune system activation; allergic reactions; or other unforeseen issues due to it being an early-phase trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has worsened after standard treatments or I couldn't tolerate 2 previous treatments.
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My genetic test shows I have the HLA-A*0201 genotype.
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I am 18 years old or older.
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My ovarian cancer was confirmed through tissue or cell testing.
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My stomach cancer was confirmed through tissue examination.
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My cancer has spread or cannot be removed by surgery.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My colon or rectum cancer was confirmed by lab tests.
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My cancer has worsened after the last treatment or I couldn't tolerate the treatment.
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My pancreatic cancer was confirmed through tissue examination.
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My cancer has spread or can't be removed and has gotten worse after treatment or I can't tolerate the treatment.
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My cancer has spread or cannot be removed by surgery.
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My cancer has spread or cannot be removed by surgery.
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I have previously received a platinum-based treatment.
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My tumor is confirmed to be WT1 positive.
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I have previously received treatment with fluoropyrimidine or gemcitabine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Limiting Toxicity
Maximum Tolerated Dose
Serum PK AUC for CUE-102
+2 more
Secondary outcome measures
Antitumor Clinical Benefit Rate with Treatment of CUE-102
Antitumor Duration of Response with Treatment of CUE-102
Antitumor Response Rate with Treatment of CUE-102
+5 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: CUE-102 Dose Expansion at Determined RP2DExperimental Treatment1 Intervention
Dose expansion of CUE-102 at determined RP2D Monotherapy IV infusion every 3 weeks for up to 2 years
Group II: CUE-102 (8 mg/kg) Dose EscalationExperimental Treatment1 Intervention
CUE-102 (8 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years
Group III: CUE-102 (4 mg/kg) Dose EscalationExperimental Treatment1 Intervention
CUE-102 (4 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years
Group IV: CUE-102 (2 mg/kg) Dose EscalationExperimental Treatment1 Intervention
CUE-102 (2 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years
Group V: CUE-102 (1mg/kg) Dose EscalationExperimental Treatment1 Intervention
CUE-102 (1 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years

Find a Location

Who is running the clinical trial?

Cue BiopharmaLead Sponsor
2 Previous Clinical Trials
115 Total Patients Enrolled
Matteo Levisetti, MDStudy ChairCue Biopharma
1 Previous Clinical Trials
85 Total Patients Enrolled

Media Library

CUE-102 (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05360680 — Phase 1
Pancreatic Cancer Research Study Groups: 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
Pancreatic Cancer Clinical Trial 2023: CUE-102 Highlights & Side Effects. Trial Name: NCT05360680 — Phase 1
CUE-102 (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05360680 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant quota for this particular trial?

"Affirmative, the data posted on clinicaltrials.gov suggests that this medical trial is actively searching for participants. Initially published on June 14th 2022 and last updated July 5th of the same year; presently it looks to recruit 52 patients from two distinct sites."

Answered by AI

What outcomes is this clinical trial attempting to attain?

"The primary outcome, which is estimated to be measured within 21 days according to the clinical trial sponsor Cue Biopharma, will focus on Dose Limiting Toxicity. Additionally, this study plans to assess secondary metrics such as Safety and Tolerability of CUE-102 Assessed by NCI CTCAE v5.0, Immune Response Assessed by CTL Markers of Activation and Antitumor Response Rate with Treatment of CUE-102 using RECIST 1.1 parameters."

Answered by AI

To what extent could CUE-102 pose risks to patients?

"Due to the small amount of clinical data available, CUE-102 was assigned a score of 1 on our safety scale. This is because it is currently undergoing Phase 1 trials and thus has limited evidence surrounding its efficacy and security."

Answered by AI

Are there any remaining opportunities to participate in this clinical experiment?

"According to the information posted on clinicaltrials.gov, this trial is enrolling subjects at present. The experiment was initially made public on June 14th 2022 with a recent update on July 5th 2022."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Johns Hopkins University
Northwest Medical Specialties, PLLC
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

Did capox after initial surgery then was clear. Then had spleen met and no chemo. After spleen met removed noticed liver Mets. Did 8 rounds folfiri and 2 with Bev. Haven’t failed any chemos. I have two tumors on anterior abdominal wall at incision sites from splenectomy. Plan is to go back on capox in two weeks while waiting for til trial but would consider this trial also. Let me know your thoughts.
PatientReceived no prior treatments
~14 spots leftby Dec 2024