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Monoclonal Antibodies

CGX1321 for Gastrointestinal Cancer

Phase 1
Waitlist Available
Research Sponsored by Curegenix Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 55 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

This trial is testing a new drug called CGX1321 alone and with other drugs to treat advanced cancers. It focuses on patients with GI and colorectal tumors, including those with a specific mutation. The goal is to find the safest dose and see how well the treatment works.

Eligible Conditions
  • Solid Tumors
  • Gastrointestinal Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~55 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 55 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants with adverse events and/or abnormal laboratory values that are related to treatment
Secondary study objectives
CGX1321 area under the curve
CGX1321 half-life
CGX1321 maximum or peak concentration
+2 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm 3: CGX1321 in combination with encorafenib + cetuximab, dose escalation and dose expansionExperimental Treatment3 Interventions
Arm 3: Phase 1b: Ascending doses of CGX1321, once daily, orally for 3 weeks (21 days) followed by a one-week (7 day) washout period in combination with enocrafenib administered orally once daily and cetuximab administered IV once weekly
Group II: Arm 2: CGX1321 in combination with pembrolizumab dose escalation, dose expansion and Roll-over,Experimental Treatment2 Interventions
Arm 2: Roll-over Cohort: CGX1321 at a dose identified in Phase 1b, once daily, orally, for 2 weeks (14 days) followed by a one-week (7-day) washout period in combination with pembrolizumab administered IV once every three weeks (in each 21-day cycle). Arm 2: Phase 1b: Ascending doses of CGX1321, once daily, orally, for 2 weeks (14 days) followed by a one-week (7-day) washout period in combination with pembrolizumab administered IV once every three weeks (in each 21-day cycle).
Group III: Arm 1: CGX1321 Single Agent dose escalation and dose expansionExperimental Treatment1 Intervention
Arm 1: Dose Escalation Phase: Ascending doses of CGX1321 once daily, orally, for 3 weeks (21 days) followed by a one-week (7-day) washout period in each 28-day cycle Dose Expansion Phase: CGX1321, at the MTD (identified in the Dose Escalation Phase), once daily, orally, for 3 weeks (21 days) followed by a one-week (7-day) washout period in each 28-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2810
Encorafenib
FDA approved
Cetuximab
FDA approved

Find a Location

Who is running the clinical trial?

Curegenix Inc.Lead Sponsor
1 Previous Clinical Trials
39 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,985 Previous Clinical Trials
5,178,629 Total Patients Enrolled
~7 spots leftby Oct 2025
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