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Monoclonal Antibodies

CGX1321 for Gastrointestinal Cancer

Q: What is the scope of the participants in this medical experiment?

<p>The sponsor of this trial, Merck Sharp &#x26; Dohme LLC, will be managing the study at Duke <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center in Durham and Gettysburg Cancer Center. In order to commence the research project 72 participants who meet the eligibility criteria must be recruited from these locations.</p>

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

Study Summary

This trial is testing the safety and effectiveness of CGX1321, a new drug for solid tumors. The trial has two phases: Phase 1 is testing CGX1321 by itself and in combination with another cancer drug, while Phase 2 is testing CGX1321 in combination with two other cancer drugs.

Eligible Conditions

Solid Tumors
Gastrointestinal Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 55 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with adverse events and/or abnormal laboratory values that are related to treatment

Secondary outcome measures

CGX1321 area under the curve

CGX1321 half-life

CGX1321 maximum or peak concentration

+2 more

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 2

~2010

Encorafenib

FDA approved

Cetuximab

FDA approved

Do I qualify?Apply below to find out

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

3,886 Previous Clinical Trials

5,054,499 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other experiments have incorporated CGX1321 as a component?

"CGX1321 was first scrutinized in 2010 by the City of Hope medical centre. To date, 347 associated studies have been completed and 961 are actively enrolling patients, with a large proportion conducted at Durham's facilities."

Answered by AI

What therapeutic indications is CGX1321 regularly prescribed for?

"CGX1321 is the go-to treatment for malignant neoplasms and has proven to be efficacious in treating unresectable melanoma, microsatellite instability high, as well as disease progression following chemotherapy."

Answered by AI

What is the scope of the participants in this medical experiment?

"The sponsor of this trial, Merck Sharp & Dohme LLC, will be managing the study at Duke Cancer Center in Durham and Gettysburg Cancer Center. In order to commence the research project 72 participants who meet the eligibility criteria must be recruited from these locations."

Answered by AI

Has CGX1321 been officially sanctioned by the Food and Drug Administration?

"CGX1321 has only been tested on a small group of patients, so its safety rating stands at 1."

Answered by AI

How many facilities are participating in this trial?

"This clinical experiment is taking place in 27 different sites, including the Duke Cancer Center and Duke University Medical Centre in Durham, North carolina; Gettysburg Cancer Facility in Gettysburg, Pennsylvania; and CSNF Cancer Specialists of North Florida (QCCA) located in Jacksonville, Florida."

Answered by AI

Is there room for additional participants in this experiment?

"Affirmative. Per the information published on clinicaltrials.gov, this medical trial is still recruiting participants and was initially posted to the platform on February 1st 2016. The study aims to enrol 72 individuals from 23 different sites across the country."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CGX1321 in Subjects With Advanced Solid Tumors and CGX1321 With Pembrolizumab or Encorafenib + Cetuximab in Subjects With Advanced GI Tumors (Keynote 596)

2016. "CGX1321 in Subjects With Advanced Solid Tumors and CGX1321 With Pembrolizumab or Encorafenib + Cetuximab in Subjects With Advanced GI Tumors (Keynote 596)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02675946.