89 Participants Needed

RGX-202-01 Combination Therapy for Colorectal Cancer

Recruiting at 54 trial locations
MS
SK
SH
Overseen ByStephanie Hansen
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a Phase 1 study currently evaluating PO administered ompenaclid in combination with FOLFIRI and bevacizumab in patients with advanced (i.e., locally advanced and unresectable, or metastatic) previously treated colorectal adenocarcinoma. The single agent ompenaclid dose escalation stage and the ompenaclid in combination with FOLFIRI and bevacizumab dose escalation stage of the study has been completed; the expansion stage of ompenaclid in combination with FOLFIRI and bevacizumab is ongoing. In April-24 a protocol amendment added a new dose escalation and expansion stage which will evaluate ompenaclid in combination with FOLFOX and bevacizumab in patients with metastatic CRC. It is anticipated that a total of 30 patients will be enrolled in this new dose escalation and expansion stage of the study.

Who Is on the Research Team?

RW

Robert Wasserman, MD

Principal Investigator

CMO

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My heart pumps well, with an ejection fraction of 45% or higher.
My blood clotting tests are within normal limits and if on warfarin, my dose is stable with INR <3.5.
My organs are functioning well.
See 10 more

Exclusion Criteria

Patient has corrected QT interval (QTc) prolongation to >470 ms (females) or >450 ms (males)
I have a condition that affects how my body absorbs nutrients.
I have a history of bleeding disorders or tend to develop blood clots.
See 22 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Ompenaclid is administered in combination with FOLFIRI or FOLFOX and bevacizumab to determine the maximum tolerated dose

28-day cycles
Visits on Days 1 and 15 of each cycle

Expansion Stage

Further characterization of efficacy, safety, and pharmacokinetics of ompenaclid in combination with FOLFIRI or FOLFOX and bevacizumab

Ongoing
Visits on Days 1 and 15 of each cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • Bevacizumab
  • FOLFIRI
  • RGX-202-01
Trial Overview 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.
How Is the Trial Designed?
5Treatment groups
Experimental Treatment
Group I: Single agent Ompenaclid (RGX-202-01) Dose EscalationExperimental Treatment1 Intervention
Group II: Ompenaclid (RGX-202-01) in combination with FOLFOX Dose ExpansionExperimental Treatment3 Interventions
Group III: Ompenaclid (RGX-202-01) in combination with FOLFOX Dose EscalationExperimental Treatment3 Interventions
Group IV: Ompenaclid (RGX-202-01) in combination with FOLFIRI Dose EscalationExperimental Treatment2 Interventions
Group V: Expansion: 2nd Line Colorectal Cancer (CRC) KRAS (+)Experimental Treatment3 Interventions

FOLFIRI is already approved in European Union, United States, Canada, Japan for the following indications:

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Approved in European Union as FOLFIRI for:
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Approved in United States as FOLFIRI for:
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Approved in Canada as FOLFIRI for:
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Approved in Japan as FOLFIRI for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rgenix, Inc.

Lead Sponsor

Trials
3
Recruited
260+

Inspirna, Inc.

Lead Sponsor

Trials
3
Recruited
320+
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