CUE-102 for Glioblastoma

Recruiting at 1 trial location

Overseen By David Reardon, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: David Reardon, MD

Must not be taking: Immunosuppressants, Anticoagulants

Disqualifiers: Immunodeficiency, Active infection, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: 18

Duration: up to 1 year

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this study is to evaluate the safety of the experimental drug, CUE-102, and establish the recommended dose of CUE-102 for participants with Recurrent Glioblastoma (GBM). The name of the study drug involved in this study is: -CUE-102 (a type of fusion protein)

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications. However, you must be at least 4 weeks from your last chemotherapy cycle and cannot be on certain immunosuppressive therapies or high-dose corticosteroids before enrolling. It's best to discuss your specific medications with the trial team.

Who Is on the Research Team?

David Reardon, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

Adults over 18 with recurrent Grade 4 glioblastoma or malignant glioma, who've completed initial radiation and chemotherapy. They must not be pregnant, agree to use contraception, have specific organ and marrow function, no severe autoimmune diseases or infections, stable corticosteroid doses, a Karnofsky performance status ≥ 70, and no recent significant cardiovascular issues.

Inclusion Criteria

I have completed my initial radiation therapy as prescribed.

Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 72 hours prior to enrollment and agree to use highly effective contraception

My organ and bone marrow functions meet the required health standards.

Exclusion Criteria

My tumor is mainly in my brainstem or spinal cord.

My tumor has come back or gotten worse more than once.

I don't have any health issues that could affect the trial's results or my participation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive CUE-102 daily for up to 1 year, with imaging every 9 weeks starting at Cycle 3

up to 1 year

17 cycles, Day 1 of 21-day cycle

End of Treatment

End of Treatment visit with imaging to assess response

Long-Term Follow-up

Participants are monitored every 3-4 months for safety and effectiveness after treatment

every 3-4 months

What Are the Treatments Tested in This Trial?

Interventions

• CUE-102

Trial Overview The trial is testing the safety of CUE-102 (a fusion protein) for treating recurrent Glioblastoma. It aims to establish the recommended dose for patients by monitoring their response and any side effects that occur during treatment.

How Is the Trial Designed?

Group I: CUE-102 Experimental Treatment 1 Intervention

The first 12 participants will be enrolled using a standard 3 + 3 design in a safety lead-in to determine the maximum tolerated dose (MTD) of CUE-102 per protocol. Once the MTD has been determined, up to 6 additional participants will be enrolled in a dose expansion cohort. Participants will complete: * Baseline visit * Imaging every 9 weeks starting at Cycle 3 * Cycle 1 through End of Treatment (up to 1 year in total, approximately 17 cycles) --Day 1 of 21 day cycle: Predetermined dose of CUE-102 1x daily. * End of Treatment visit with imaging * Long-Term Follow Up: every 3-4 months

Who Is Running the Clinical Trial?

David Reardon, MD

Lead Sponsor

Cue Biopharma

Industry Sponsor

Trials

3

Recruited

160+