CUE-102 for Cancer

No longer recruiting at 14 trial locations

Overseen By Lei Zheng, M.D, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Cue Biopharma

Must not be taking: Corticosteroids, Immunosuppressive drugs

Disqualifiers: Pregnancy, CNS metastases, Autoimmune disease, Transplant history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CUE-102 for certain cancers, including colorectal, gastric, pancreatic, and ovarian cancers. Researchers aim to assess its safety, tolerability, and effectiveness in fighting tumors. Participants will receive CUE-102 through an IV every three weeks for up to two years. Ideal candidates have WT1-positive tumors, have tried other unsuccessful treatments, and possess specific genetic markers (HLA-A*0201). As a Phase 1 trial, this research focuses on understanding how CUE-102 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the CUE-102 trial?

The trial protocol does not specify if you need to stop your current medications. However, you must not have had any systemic anti-cancer therapy or investigational therapy within 14 days (or 28 days for antibody drugs) before starting CUE-102. It's best to discuss your current medications with the trial team.

Is there any evidence suggesting that CUE-102 is likely to be safe for humans?

Research has shown that CUE-102 is safe for patients. In earlier studies, doses ranging from 1 mg/kg to 8 mg/kg did not cause severe side effects that would halt treatment. Most side effects were mild, with over 96% being minor. Common side effects included tiredness and mild reactions during infusion. These results suggest that patients generally tolerate CUE-102 well. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about CUE-102 because it targets cancer in a novel way. Unlike traditional treatments like chemotherapy, which attack both cancerous and healthy cells, CUE-102 is designed to precisely target cancer cells while sparing normal cells. This targeted approach aims to reduce side effects and improve effectiveness. The treatment is administered via IV infusion every three weeks, allowing for consistent and controlled delivery. With these unique features, CUE-102 could offer a more efficient and patient-friendly option for cancer patients.

What evidence suggests that CUE-102 could be an effective treatment for cancer?

Research has shown that CUE-102 yields promising results for treating cancers with WT1-positive tumors. In one study, CUE-102 controlled the disease in 67% of late-stage pancreatic cancer cases, with some tumors shrinking by 40%. This treatment boosts the immune system to attack cancer cells with the WT1 protein, common in many solid tumors. Patients tolerated it well, with most side effects being mild, such as fatigue. These early findings suggest that CUE-102 could be a promising option for patients with hard-to-treat cancers. Participants in this trial will receive different dosages of CUE-102 to determine the optimal dose for treatment. ^{1 3 4 6 7}

Who Is on the Research Team?

Matteo Levisetti, MD

Principal Investigator

Cue Biopharma

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Acceptable laboratory parameters

All tumors must have histologically or cytologically confirmed cancer diagnosis

My cancer has worsened after standard treatments or I couldn't tolerate 2 previous treatments.

Exclusion Criteria

Known hypersensitivity to recombinant proteins, polysorbate 80 or any excipient contained in the drug formulation for CUE-102

I have a history of serious heart problems.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive CUE-102 monotherapy IV infusion every 3 weeks to determine the maximum tolerated dose and establish a recommended Phase 2 dose

21 days for initial dose-limiting toxicity assessment, up to 2 years for continued treatment

Every 3 weeks

Dose Expansion

Participants receive CUE-102 at the recommended Phase 2 dose to expand safety and immune activity data and evaluate antitumor activity

Up to 2 years

Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

• CUE-102

Trial Overview 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.

How Is the Trial Designed?

Group I: CUE-102 Dose Expansion at Determined RP2D Experimental Treatment 1 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 Escalation Experimental Treatment 1 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 Escalation Experimental Treatment 1 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 Escalation Experimental Treatment 1 Intervention

CUE-102 (2 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years

Group V: CUE-102 (1mg/kg) Dose Escalation Experimental Treatment 1 Intervention

CUE-102 (1 mg/kg) Monotherapy IV infusion every 3 weeks for up to 2 years

Who Is Running the Clinical Trial?

Cue Biopharma

Lead Sponsor

Trials

3

Recruited

160+

Citations

1. cuebiopharma.gcs-web.com cuebiopharma.gcs-web.com/news-releases/news-release-details/cue-biopharma-presents-positive-updated-data-its-phase-1-trials

Cue Biopharma Presents Positive Updated Data from its ... Objective response rate (ORR) of 46%, 12-month overall survival (OS) of 91.3% and a median overall survival (mOS) of 21.8 months in first line (1L) HPV+ R/M ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.3553

A phase 1, open-label, dose escalation, and expansion ... CUE-102 was well-tolerated with > 96% of treatment-related adverse events (TRAEs) grade ≤2. The most common TRAEs, were fatigue, infusion ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05360680

NCT05360680 | A Phase 1 in Patients With HLA-A*0201+ ... 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 ...

4. trial.medpath.com trial.medpath.com/news/9d4e41c04a27ebfb/cue-biopharma-presents-positive-updated-data-from-its-phase-1-trials-of-cue-101-biospace

Cue Biopharma's CUE-101 and CUE-102 Show Promise in ... CUE-102 monotherapy shows a 67% overall disease control rate in late-stage pancreatic cancer, including an unconfirmed partial response with a 40% tumor ...

5. targetedonc.com targetedonc.com/view/phase-1-trial-of-cue-102-in-wt1-solid-tumors-is-now-in-motion

Phase 1 Trial of CUE-102 in WT1+ Solid Tumors is Now ... “CUE-102 has the potential to activate the patient's immune system against numerous WT1-expressing cancers, including solid tumors and ...

6. jitc.bmj.com jitc.bmj.com/content/11/Suppl_1/A846

750 A phase 1 trial of CUE-102, a novel WT1-pHLA-IL2-Fc ... Results 12 patients have received CUE-102 monotherapy as of June 27, 2023. Doses ranging from 1 mg/kg to 4 mg/kg were determined to be safe and ...

7. cuebiopharma.com cuebiopharma.com/wp-content/uploads/2023/11/Cue_Biopharma_SITC_2023_CUE-102.pdf

Safety and Tolerability Background Enrollment by Cancer ... CUE-102-01 is a phase 1, open-label, 2-part, multi-center study evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics ...