CUE-102 for Cancer

Recruiting at 13 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

42 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Matteo Levisetti, MD

Principal Investigator

Cue Biopharma

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+