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Study Summary
This trial is testing a new cancer drug to see if it is safe and effective.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My cancer has worsened after standard treatments or I couldn't tolerate 2 previous treatments.My cancer has spread or cannot be removed by surgery.My cancer can be measured and has been confirmed by a scan.My ovarian cancer was confirmed through tissue examination.I am 18 years old or older.I have a history of serious heart problems.My stomach cancer was confirmed through tissue examination.My cancer is in the stomach or where the stomach meets the esophagus.I haven't had a serious infection needing IV treatment in the last week.My ovarian cancer was confirmed through tissue or cell testing.I have another cancer that has not been in remission for more than 2 years.I have severe kidney problems.I do not have any health or mental conditions that would stop me from receiving the study treatment.I have not had severe side effects from immune checkpoint inhibitor therapy.My stomach cancer was confirmed through tissue examination.I am able to understand and give consent for my treatment.My cancer has spread or cannot be removed by surgery.My genetic test shows I have the HLA-A*0201 genotype.I have severe nerve damage symptoms.I have not had major surgery or serious injury in the last 28 days.My cancer is in the stomach or where the stomach meets the esophagus.I have colorectal cancer.My cancer can be measured and has been confirmed by a scan.I have a serious stomach or intestine condition.My cancer responds to platinum drugs and I've had them before considering CUE-102.I have had treatment for brain metastases and currently have no symptoms.I haven't needed systemic treatment for an autoimmune disease in the last 2 years.I am fully active or restricted in physically strenuous activity but can do light work.I have ovarian cancer.I had previous immune therapy with manageable side effects or controlled thyroid issues.I haven't taken any cancer drugs or been in a trial for at least 14 days.I am currently breastfeeding.My cancer type is listed as eligible for the trial.I have ovarian cancer.My cancer has spread or cannot be removed by surgery.I do not have cancer spread to the lining of my brain or spinal cord.I have not had radiation therapy in the last 14 days.I am not pregnant and do not plan to become pregnant during the trial.I have severe inflammation of my colon.My colon or rectum cancer was confirmed by lab tests.My cancer has worsened after the last treatment or I couldn't tolerate the treatment.My pancreatic cancer was confirmed through tissue examination.I need extra oxygen to breathe properly.My cancer has spread or can't be removed and has gotten worse after treatment or I can't tolerate the treatment.I need treatment for my brain disease, like surgery or high-dose steroids.I have severe eye side effects.I have pancreatic cancer.My brain metastases have worsened 28 days after my last treatment.My cancer has spread or cannot be removed by surgery.My cancer has spread or cannot be removed by surgery.I don't have HIV, Hepatitis B, or Hepatitis C.I haven't taken high doses of steroids or immune suppressants in the last 14 days.I have previously received a platinum-based treatment.My cancer responds to platinum drugs and I've had them before considering CUE-102.I haven't had a live virus vaccine in the last 28 days, except for the flu shot.My tumor is confirmed to be WT1 positive.I have previously received treatment with fluoropyrimidine or gemcitabine.I am a man who can father children and will use barrier contraception during and for 90 days after the study.My cancer has spread or cannot be removed by surgery.My cancer has spread or can't be removed and has gotten worse after standard treatments.
- Group 1: CUE-102 (1mg/kg) Dose Escalation
- Group 2: CUE-102 (2 mg/kg) Dose Escalation
- Group 3: CUE-102 (4 mg/kg) Dose Escalation
- Group 4: CUE-102 (8 mg/kg) Dose Escalation
- Group 5: CUE-102 Dose Expansion at Determined RP2D
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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