CUE-102 for Colorectal Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Johns Hopkins University, Baltimore, MDColorectal Cancer+3 MoreCUE-102 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new cancer drug to see if it is safe and effective.

Eligible Conditions
  • Stomach Cancer
  • Ovarian Cancer
  • Colorectal Cancer
  • Pancreatic Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
NBF-006
1
BOLD-100 in combination with FOLFOX Chemotherapy
1
CYAD-101

Study Objectives

5 Primary · 8 Secondary · Reporting Duration: Up to 2 years

21 Days
Dose Limiting Toxicity
Maximum Tolerated Dose
From First CUE-102 to Date of Death
Overall Survival with Treatment of CUE-102
Up to 2 years
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
Immune Response Assessed by CTL Markers of Activation
Immune Response Assessed by WW1 Tetramer-Positive T cell Lymphocytes
Progression-Free Survival with Treatment of CUE-102
Safety and Tolerability of CUE-102 Assessed by NCI CTCAE v5.0
Serum PK AUC for CUE-102
Serum PK Cmax for CUE-102
Serum PK T1/2 for CUE-102

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
NBF-006
1
BOLD-100 in combination with FOLFOX Chemotherapy
1
CYAD-101

Trial Design

5 Treatment Groups

CUE-102 (1mg/kg) Dose Escalation
1 of 5
CUE-102 (4 mg/kg) Dose Escalation
1 of 5
CUE-102 (2 mg/kg) Dose Escalation
1 of 5
CUE-102 Dose Expansion at Determined RP2D
1 of 5
CUE-102 (8 mg/kg) Dose Escalation
1 of 5

Experimental Treatment

52 Total Participants · 5 Treatment Groups

Primary Treatment: CUE-102 · No Placebo Group · Phase 1

CUE-102 (1mg/kg) Dose Escalation
Drug
Experimental Group · 1 Intervention: CUE-102 · Intervention Types: Drug
CUE-102 (4 mg/kg) Dose Escalation
Drug
Experimental Group · 1 Intervention: CUE-102 · Intervention Types: Drug
CUE-102 (2 mg/kg) Dose Escalation
Drug
Experimental Group · 1 Intervention: CUE-102 · Intervention Types: Drug
CUE-102 Dose Expansion at Determined RP2D
Drug
Experimental Group · 1 Intervention: CUE-102 · Intervention Types: Drug
CUE-102 (8 mg/kg) Dose Escalation
Drug
Experimental Group · 1 Intervention: CUE-102 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Cue BiopharmaLead Sponsor
2 Previous Clinical Trials
115 Total Patients Enrolled
Matteo Levisetti, MDStudy ChairCue Biopharma

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You can participate in the study if you have colorectal, gastric, pancreatic, or ovarian cancer that has spread or cannot be removed surgically, and if you have not responded to or cannot tolerate standard treatments. You must also have a certain genetic makeup, and your tumors must test positive for a specific protein. Women of childbearing age and sexually active men must use contraception during the study and for 90 days after it ends. If you have previously received an immune therapy medication, any related side effects must have resolved or be under control.
You are expected to live for at least 12 more weeks.
References

Frequently Asked Questions

What is the participant quota for this particular trial?

"Affirmative, the data posted on clinicaltrials.gov suggests that this medical trial is actively searching for participants. Initially published on June 14th 2022 and last updated July 5th of the same year; presently it looks to recruit 52 patients from two distinct sites." - Anonymous Online Contributor

Unverified Answer

What outcomes is this clinical trial attempting to attain?

"The primary outcome, which is estimated to be measured within 21 days according to the clinical trial sponsor Cue Biopharma, will focus on Dose Limiting Toxicity. Additionally, this study plans to assess secondary metrics such as Safety and Tolerability of CUE-102 Assessed by NCI CTCAE v5.0, Immune Response Assessed by CTL Markers of Activation and Antitumor Response Rate with Treatment of CUE-102 using RECIST 1.1 parameters." - Anonymous Online Contributor

Unverified Answer

To what extent could CUE-102 pose risks to patients?

"Due to the small amount of clinical data available, CUE-102 was assigned a score of 1 on our safety scale. This is because it is currently undergoing Phase 1 trials and thus has limited evidence surrounding its efficacy and security." - Anonymous Online Contributor

Unverified Answer

Are there any remaining opportunities to participate in this clinical experiment?

"According to the information posted on clinicaltrials.gov, this trial is enrolling subjects at present. The experiment was initially made public on June 14th 2022 with a recent update on July 5th 2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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.
Back to top