18 and older, any sex, with Colorectal Cancer or Metastatic Colon Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response RatePrimary· From randomization until development of radiographic disease progression (up to approximately 12 months).
ORR is defined as the proportion of patients achieving a best overall response (BOR) of complete response (CR) or partial response (PR) per the investigators using RECIST version 1.1. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
All randomized participants
Group
Value
95% CI
Ompenaclid + FOLFIRI + Bevacizumab
8
Placebo + FOLFIRI + Bevacizumab
8
Participants treated with prior bevacizumab
Group
Value
95% CI
Ompenaclid + FOLFIRI + Bevacizumab
2
Placebo + FOLFIRI + Bevacizumab
4
Participants untreated with prior bevacizumab
Group
Value
95% CI
Ompenaclid + FOLFIRI + Bevacizumab
6
Placebo + FOLFIRI + Bevacizumab
4
Progression-Free Survival (PFS)Secondary· From randomization until development of radiographic disease progression or death due to any cause, whichever comes first.
PFS is defined as the time from the date of randomization to the date of objectively determined progressive disease (PD) per the investigators using RECIST version 1.1 or death from any cause, whichever occurs first (up to approximately 12 months).
Group
Value
95% CI
Ompenaclid + FOLFIRI + Bevacizumab
8.8
5.72 – 11.10
Placebo + FOLFIRI + Bevacizumab
8.1
5.55 – 10.94
Overall Survival (OS)Secondary· From randomization until death due to any cause.
OS is defined as the time from the date of randomization to the date of death from any cause. The proportions of participants who have not experienced OS events (death) at 9 months and 12 months are presented.
OS rate at 9 months
Group
Value
95% CI
Ompenaclid + FOLFIRI + Bevacizumab
88.5
79.5052 – 97.4717
Placebo + FOLFIRI + Bevacizumab
69.0
55.3450 – 82.6884
OS rate at 12 months
Group
Value
95% CI
Ompenaclid + FOLFIRI + Bevacizumab
88.5
79.5052 – 97.4717
Placebo + FOLFIRI + Bevacizumab
61.3
44.3449 – 78.3514
Duration of Response (DoR)Secondary· From randomization until development of radiographic disease progression or death due to any cause, whichever comes first (up to approximately 12 months).
DoR is defined as the time from the date of objectively determined PR or CR (whichever status is recorded first) to the date of PD per the investigators using RECIST version 1.1 or death from any cause, whichever occurs first. The median DoR was not reached in both groups.
Group
Value
95% CI
Ompenaclid + FOLFIRI + Bevacizumab
NA
2.04 – NA
Placebo + FOLFIRI + Bevacizumab
NA
NA – NA
Disease Control Rate (DCR)Secondary· From randomization until development of radiographic disease progression (up to approximately 12 months).
DCR is defined as the proportion of patients achieving a BOR of CR, PR, or stable disease (SD).
Group
Value
95% CI
Ompenaclid + FOLFIRI + Bevacizumab
36
Placebo + FOLFIRI + Bevacizumab
30
Frequency of Adverse Events (AEs)Secondary· From the signing of informed consent until 30 days (+/- 3 days) after the last dose of study drug (up to approximately 12 months).
Percentage of patients with treatment-emergent AEs (TEAE).
Group
Value
95% CI
Ompenaclid + FOLFIRI + Bevacizumab
37
Placebo + FOLFIRI + Bevacizumab
38
Pharmacokinetics of OmpenaclidSecondary· At Cycle 1 day 15 and Cycle 2 day 15 (each cycle is 28 days in length)
Steady state concentration of ompenaclid.
C1D15
Group
Value
95% CI
Ompenaclid + FOLFIRI + Bevacizumab
2686
± 2372
C2D15
Group
Value
95% CI
Ompenaclid + FOLFIRI + Bevacizumab
2909
± 2333
Progression-Free Survival (PFS) Rate at 6 and 9 MonthsSecondary· From randomization until development of radiographic disease progression or death due to any cause, whichever comes first.
PFS is defined as the time from the date of randomization to the date of objectively determined progressive disease (PD) per the investigators using RECIST version 1.1 or death from any cause, whichever occurs first. The proportions of participants who have not experienced PFS events (radiological disease progression or death) at 6 months and 9 months are presented.
PFS rate at 6 months
Group
Value
95% CI
Ompenaclid + FOLFIRI + Bevacizumab
63.4
49.4708 – 77.3846
Placebo + FOLFIRI + Bevacizumab
62.8
49.1564 – 76.3769
PFS rate at 9 months
Group
Value
95% CI
Ompenaclid + FOLFIRI + Bevacizumab
48.4
33.1111 – 63.6604
Placebo + FOLFIRI + Bevacizumab
46.2
30.6150 – 61.6889
Adverse events — posted to ClinicalTrials.gov
Time frame: All adverse events, including all-cause mortality, were assessed from the date of the first dose of ompenaclid or placebo to 30 days following the date of the last dose (up to approximately 12 months)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to measure tumor response to treatment with ompenaclid (RGX-202-01) in patients with previously treated RAS mutant advanced or metastatic CRC. All patients will receive treatment with FOLFIRI and bevacizumab. In addition, patients will be randomized to receive either ompenaclid 3000 mg BID or matching placebo (herein referred to as Study Drug). Each treatment cycle is 28 days in duration.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07152821 — Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcino
· Phase 3
· recruiting
NCT07353645 — KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer
· Phase 1, PHASE2
· recruiting
NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications
· Phase 1, PHASE2
· recruiting
NCT07523919 — Functional and Respiratory Determinants of Long-Term Colorectal Cancer Outcomes
· recruiting
NCT07529301 — Functional and Respiratory Predictors of Early Postoperative Outcomes
· recruiting
Other Inspirna, Inc. trials
Trials by the same sponsor.
NCT03597581 — A Study of RGX-202-01 (Ompenaclid) as Combination Therapy in RAS Mutant Advanced Colorectal Cancer
· Phase 1
· completed
NCT02922764 — A Study of RGX-104 in Patients With Advanced Lung & Endometrial Cancer
· Phase 1
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Inspirna, Inc.
Last refreshed: 20 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05983367.