CUE-102 for Cancer
Recruiting at 13 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Cue Biopharma
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
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
ML
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.
See 26 more
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.
See 26 more
Treatment Details
Interventions
- CUE-102
Trial OverviewThe 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
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cue Biopharma
Lead Sponsor
Trials
3
Recruited
160+
Other People Viewed
By Subject
By Trial
Related Searches
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.