What side effects are associated with this type of intervention?

Common treatments for ovarian cancer include chemotherapy (e.g., paclitaxel, carboplatin), targeted therapy (e.g., PARP inhibitors like olaparib), and immunotherapy (e.g., pembrolizumab). Chemotherapy often causes side effects such as fatigue, nausea, hair loss, and increased risk of infection. PARP inhibitors can lead to anemia, nausea, and fatigue. Immunotherapy, which is similar to the immune modulation approach in CUE-102, may cause immune-related side effects like fatigue, rash, diarrhea, and inflammation of organs (e.g., pneumonitis, colitis).

What prior FDA approvals exist?

The FDA has approved several immune modulation therapies for ovarian cancer, although specific approvals targeting WT1 positive tumor cells like CUE-102 are not explicitly mentioned. Notable approvals include pembrolizumab, an anti-PD-1 monoclonal antibody, which has shown efficacy in various cancers, including ovarian cancer, particularly in patients with high microsatellite instability or mismatch repair deficiency. Additionally, PARP inhibitors such as olaparib, niraparib, and rucaparib have been approved for ovarian cancer, especially in patients with BRCA mutations, offering a targeted approach to treatment. These therapies represent significant advancements in the management of ovarian cancer through immune modulation and targeted mechanisms.

What other types of research exist?

Promising novel alternatives to CUE-102 for ovarian cancer patients in 2024 include: 1) GD2-CAR T cell therapy, which has shown efficacy in other solid tumors; 2) ONC201, a selective DRD2 antagonist, which has demonstrated antitumor activity in clinical trials; and 3) Nivolumab plus Ipilimumab, a combination of immune checkpoint inhibitors that has been effective in various cancers. These therapies are in advanced stages of clinical trials and may offer new hope for ovarian cancer patients.

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Cancer Vaccine

CUE-102 for Cancer

Phase 1

Waitlist Available

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

Must not have

History of clinically significant cardiovascular disease

Evidence of active viral, bacterial, or systemic fungal infection requiring parenteral treatment within 7 days before the first dose of CUE-102

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medicine called CUE-102 that helps the immune system fight cancer more effectively. It targets patients whose cancer hasn't responded to other treatments. The medicine works by activating immune cells to attack cancer cells more precisely.

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.

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.

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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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of serious heart problems.

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I haven't had a serious infection needing IV treatment in the last week.

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I have another cancer that has not been in remission for more than 2 years.

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I have severe kidney problems.

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I do not have any health or mental conditions that would stop me from receiving the study treatment.

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I have not had severe side effects from immune checkpoint inhibitor therapy.

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I am able to understand and give consent for my treatment.

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I have severe nerve damage symptoms.

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I have a serious stomach or intestine condition.

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I have had treatment for brain metastases and currently have no symptoms.

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I haven't needed systemic treatment for an autoimmune disease in the last 2 years.

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I am currently breastfeeding.

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I do not have cancer spread to the lining of my brain or spinal cord.

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I am not pregnant and do not plan to become pregnant during the trial.

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I have severe inflammation of my colon.

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I need extra oxygen to breathe properly.

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I need treatment for my brain disease, like surgery or high-dose steroids.

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I have severe eye side effects.

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I haven't taken high doses of steroids or immune suppressants in the last 14 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose Limiting Toxicity

Maximum Tolerated Dose

Serum PK AUC for CUE-102

+2 more

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 34Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ovarian cancer include chemotherapy, targeted therapy, and immune modulation. Chemotherapy, such as platinum-based agents, works by damaging the DNA of rapidly dividing cancer cells, leading to cell death. Targeted therapies, like PARP inhibitors and angiogenesis inhibitors, interfere with specific molecules involved in tumor growth and blood vessel formation, respectively. Immune modulation, exemplified by investigational treatments like CUE-102, aims to enhance the body's immune response against WT1 positive tumor cells by targeting specific antigens. This approach is significant for ovarian cancer patients as it offers a potential for more precise and effective treatment options, potentially leading to better outcomes and fewer side effects compared to traditional therapies.

Targeting tumor microenvironment in ovarian cancer: Premise and promise.Defining the molecular response to trastuzumab, pertuzumab and combination therapy in ovarian cancer.