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Chemotherapy Agent

RGX-202-01 Combination Therapy for Colorectal Cancer

Phase 1
Recruiting
Research Sponsored by Rgenix, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must have adequate cardiac function, as defined by left ventricular ejection fraction (LVEF) ≥45%
Patient must have prothrombin time ≤1.5 x ULN or international normalized ratio within ≤1.5; and either partial thromboplastin time or activated partial thromboplastin time ≤1.5 x ULN. Patients on warfarin may be included if on a stable dose with a therapeutic INR <3.5
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing a new drug, RGX-202-01, to see if it can shrink tumors in people with gastrointestinal cancer. The study will test different doses of the drug to see what is safe and effective. The study will also test the drug in combination with other drugs that are commonly used to treat gastrointestinal cancer.

Who is the study for?
Adults over 18 with RAS mutant advanced colorectal cancer that's resistant or relapsed after standard therapy, or when no effective standard therapy exists. Participants must have had only one prior oxaliplatin-based treatment for metastatic CRC and may have used certain other drugs like pembrolizumab. They need to be in good physical condition (ECOG PS 0-1), not pregnant, and without serious heart disease, infections, or psychiatric conditions.Check my eligibility
What is being tested?
The trial is testing RGX-202-01 (Ompenaclid) alone and combined with FOLFIRI +/- bevacizumab in patients who've progressed on standard therapies. It starts by finding the best dose of RGX-202-01 then moves to treating more patients at this dose to see how well it works specifically for those with RAS mutant colorectal cancer.See study design
What are the potential side effects?
Potential side effects include typical reactions from chemotherapy such as fatigue, digestive issues, blood disorders; plus specific risks from targeted agents like skin reactions and increased bleeding risk. The exact profile of RGX-202-01 will be clearer after the trial but may involve similar effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart pumps well, with an ejection fraction of 45% or higher.
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My blood clotting tests are within normal limits and if on warfarin, my dose is stable with INR <3.5.
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My colorectal cancer is RAS positive and confirmed by lab tests.
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I am 18 years old or older.
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My disease did not respond to or came back after standard treatment, or there is no effective standard treatment available.
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My tumor is confirmed to have a RAS mutation.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My cancer is a type of colorectal cancer that has spread or is advanced.
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I have had only one prior treatment with oxaliplatin for advanced colorectal cancer.
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My cancer has spread or cannot be removed by surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 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
RGX-202-01 maximum tolerated dose
RGX-202-01 overall response rate
RGX-202-01 treatment-emergent adverse events
Secondary outcome measures
RGX-202-01 area under the curve
RGX-202-01 maximum plasma concentration

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424
22%
vitreous hemorrhage
17%
worsening of cataract
9%
posterior capsule opacification
9%
vitreous syneresis
4%
cranial nerve VI palsy
4%
bradycardia
4%
pneumonia
4%
pyelonephritis
4%
colon cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bevacizumab
Ozurdex

Trial Design

3Treatment groups
Experimental Treatment
Group I: Single agent RGX-202-01 Dose EscalationExperimental Treatment1 Intervention
RGX-201-01 is administered orally twice or three times daily on days 1-28 of each 28-day cycle. The dose regimen is dependent on the cohort in which the patient is enrolled.
Group II: RGX-202-01 in combination with FOLFIRI Dose EscalationExperimental Treatment2 Interventions
RGX-201-01 is administered orally twice or three times daily on days 1-28 of each 28-day cycle. The dose regimen is dependent on the cohort in which the patient is enrolled. FOLFIRI is administered as follows: irinotecan 180 mg/m2 intravenously over 90 minutes concurrently with folinic acid (leucovorin) 400 mg/m2 intravenously over 2 hours, followed by 5-FU 400 mg/m2 intravenous bolus and then 5-FU 2400 mg/m2 intravenous infusion over 46 hours, on Days 1 and 15 of each 28-day cycle.
Group III: Expansion: 2nd Line Colorectal Cancer (CRC) KRAS (+)Experimental Treatment3 Interventions
2nd Line CRC RAS (+) RGX-201-01 is administered orally twice on days 1-28 of each 28-day cycle. FOLFIRI is administered as follows: irinotecan 180 mg/m2 intravenously over 90 minutes concurrently with folinic acid (leucovorin) 400 mg/m2 intravenously over 2 hours, followed by 5-FU 400 mg/m2 intravenous bolus and then 5-FU 2400 mg/m2 intravenous infusion over 46 hours, on Days 1 and 15 of each 28-day cycle. Bevacizumab is administered as follows: 5 mg/kg on Days 1 and 15 of each 28-day cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FOLFIRI
2005
Completed Phase 3
~5860
Bevacizumab
2013
Completed Phase 4
~5280

Find a Location

Who is running the clinical trial?

Rgenix, Inc.Lead Sponsor
2 Previous Clinical Trials
174 Total Patients Enrolled
Inspirna, Inc.Lead Sponsor
2 Previous Clinical Trials
200 Total Patients Enrolled
Robert Wasserman, MDStudy ChairCMO
3 Previous Clinical Trials
241 Total Patients Enrolled

Media Library

FOLFIRI (Chemotherapy Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03597581 — Phase 1
Gastrointestinal Cancer Research Study Groups: Single agent RGX-202-01 Dose Escalation, RGX-202-01 in combination with FOLFIRI Dose Escalation, Expansion: 2nd Line Colorectal Cancer (CRC) KRAS (+)
Gastrointestinal Cancer Clinical Trial 2023: FOLFIRI Highlights & Side Effects. Trial Name: NCT03597581 — Phase 1
FOLFIRI (Chemotherapy Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03597581 — Phase 1

Frequently Asked Questions

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

Is this investigation enrolling new participants at present?

"As per the data hosted on clinicaltrials.gov, this particular trial is still recruiting volunteers - it was first published in June of 2018 and its last revision happened on October 27th 2022."

Answered by AI

In what circumstances is RGX-202-01 commonly prescribed?

"RGX-202-01 has demonstrated efficacy when employed to treat rectal carcinoma, colorectal carcinoma, and sarcoma."

Answered by AI

Are any medical centers in North America offering this research experiment?

"Presently, 5 sites are responsible for running this trial. Locations include Santa Monica, Nashville and New york as well as two additional places. To minimize the amount of travel necessary to partake in the study, selecting a nearby site is recommended."

Answered by AI

Are there any other prior studies that have employed RGX-202-01 as a therapeutic agent?

"At present, there are 792 active research projects exploring RGX-202-01 with 212 of those studies in the final phase. There is a total of 37,438 clinical trial sites offering this medication; many of these locations are found in Shanghai."

Answered by AI

To what extent does RGX-202-01 pose a risk to those who take it?

"Due to the limited data available on RGX-202-01, our team at Power has given it a score of 1 in terms of safety. This is because this clinical trial is only in Phase 1 and therefore lacks substantial evidence for efficacy or security."

Answered by AI

What is the capacity of participation for this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this study is currently enrolling patients, having originally been posted on June 5th 2018 and most recently updated on October 27th 2022. The trial intends to recruit a total of 60 volunteers from five different medical centres."

Answered by AI
~9 spots leftby Mar 2025