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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

Must not have

Patient has a malabsorption condition, such as short bowel syndrome, impaired GI function or GI disease that may significantly alter absorption, or a high likelihood of impending bowel obstruction, such as strictures

For RGX-202-01 plus FOLFIRI and bevacizab dose escalation and expansion stages: Patient has a history of hemorrhagic diathesis or tendency towards thrombosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition that affects how my body absorbs nutrients.

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I have a history of bleeding disorders or tend to develop blood clots.

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I have had fluid removed from my abdomen or needed pain medication for it in the last 28 days.

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I do not have serious heart problems.

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I have active cancer spread to my brain or its coverings.

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I have been treated with FOLFIRI or a similar medication before.

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I do not have a DPD deficiency and haven't taken DPD inhibitors in the last 4 weeks.

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I have a specific genetic variation related to drug processing.

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I have a long-term liver condition.

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I have had severe wounds, ulcers, or bone fractures that did not heal properly.

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I have a muscle disorder diagnosis.

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My cancer is of small cell, neuroendocrine, or squamous type.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

RGX-202-01 maximum tolerated dose

RGX-202-01 overall response rate

RGX-202-01 treatment-emergent adverse events

Secondary study objectives

RGX-202-01 area under the curve

RGX-202-01 maximum plasma concentration

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Single agent Ompenaclid (RGX-202-01) Dose EscalationExperimental Treatment1 Intervention

Ompenaclid (RGX-202-01) 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: Ompenaclid (RGX-202-01) in combination with FOLFOX Dose ExpansionExperimental Treatment3 Interventions

Ompenaclid (RGX-202-01) 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. The FOLFOX regimen used for this protocol consists of oxaliplatin given at 85 mg/m2 IV together with leucovorin at 400 mg/m2 IV (substitution with levo-leucovorin 200 mg/m2 IV is allowed) (duration per institutional policy), followed by a 5-FU bolus of 400 mg/m2 (over 2-5 minutes), and then continuous infusional 5-FU given at a dose of 2400 mg/m2 over 46-48 hours (1200 mg/m2/day), given on Days 1 and 15 of each 28-day cycle. A minimum of 8 FOLFOX cycles should be received if tolerated per standard of care guidelines.

Group III: Ompenaclid (RGX-202-01) in combination with FOLFOX Dose EscalationExperimental Treatment3 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. The FOLFOX regimen used for this protocol consists of oxaliplatin given at 85 mg/m2 IV together with leucovorin at 400 mg/m2 IV (substitution with levo-leucovorin 200 mg/m2 IV is allowed) (duration per institutional policy), followed by a 5-FU bolus of 400 mg/m2 (over 2-5 minutes), and then continuous infusional 5-FU given at a dose of 2400 mg/m2 over 46-48 hours (1200 mg/m2/day), given on Days 1 and 15 of each 28-day cycle. A minimum of 8 FOLFOX cycles should be received if tolerated per standard of care guidelines.

Group IV: Ompenaclid (RGX-202-01) in combination with FOLFIRI Dose EscalationExperimental Treatment2 Interventions

Ompenaclid (RGX-202-01) 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 V: Expansion: 2nd Line Colorectal Cancer (CRC) KRAS (+)Experimental Treatment3 Interventions

2nd Line CRC RAS (+) Ompenaclid (RGX-202-01) 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

FOLFOX regimen

2009

Completed Phase 3

~2440

FOLFIRI

2005

Completed Phase 3

~5860