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New hope for Hard-to-Treat colon cancer? study tests targeted drug combo

NCT ID NCT05983367

Disease control Sponsor: Inspirna, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether adding the experimental drug ompenaclid to standard chemotherapy could shrink tumors in people with advanced colorectal cancer that has a RAS gene mutation. About 76 participants were randomly assigned to receive either ompenaclid or a placebo, along with the same chemotherapy. The study was terminated early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

76 people

The number who actually took part.

Started

Oct 2023

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. Advanced disease, defined as cancer that is either metastatic or locally advanced and unresectable and for which additional radiation therapy or other locoregional therapies are not considered feasible. 2. Progression of disease after receiving only 1 prior regimen considered standard of care for CRC in the advanced/metastatic setting, and it must have been an oxaliplatin containing regimen. Patients who have mismatch repair deficiency/ high microsatellite instability (dMMR/MSI-H) CRC must have also received prior treatment with pembrolizumab or a Food and Drug Administration (FDA)/European Union (EU)-approved programmed cell death protein 1 (PD-1)/ programmed death-ligand 1 (PD-L1) inhibitor. Patients may have received prior treatment with bevacizumab or an European Medicines Agency (EMA) approved biosimilar. Patients who developed metastatic CRC within 12 months of completion of adjuvant oxaliplatin and 5-FU based therapy are also eligible. 3. Histologic or cytologic evidence of a malignant colorectal tumor of adenocarcinoma or poorly differentiated histology that is laboratory-confirmed to be RAS mutant. Confirmation of RAS mutant status by liquid biopsy is acceptable only if the tumor sample is not available and the liquid biopsy was performed before initiation of the patient's prior treatment regimen. Patients who convert to RAS mutant status after initially having documented wild-type histology are not eligible. 4. Disease that is measurable by standard imaging techniques by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. For patients with prior radiation therapy, measurable lesions must be outside of any prior radiation field(s), unless disease progression has been documented at that disease site subsequent to radiation. 5. At least 18 years old. 6. ECOG performance score ≤ 1. 7. Adequate baseline organ function, as demonstrated by the following: 1. Calculated creatinine clearance \> 60 mL/min per institutional standard. 2. Serum albumin ≥ 2.5 g/dL. 3. Bilirubin ≤ 1.5 x institutional upper limit of normal range (ULN). 4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x institutional ULN; patients with hepatic metastases may have AST and ALT ≤ 5 x institutional ULN. 5. Absolute neutrophil count (ANC) ≥1.5x109/L. 6. Hemoglobin ≥ 8 g/dL and no red blood cell (RBC) transfusions during the prior 14 days. 7. Platelet count ≥ 100 x 109/L and no platelet transfusions during the prior 14 days. 8. If not taking warfarin (or similar vitamin K inhibitor) the following values are required: international normalized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5 x ULN and either partial thromboplastin time or activated partial thromboplastin time (PTT or aPTT) ≤ 1.5 x ULN. Patients on warfarin (or similar vitamin K inhibitor) may be included if on a stable dose with a therapeutic INR \< 3.5. 9. Left ventricular ejection fraction (LVEF) x 45% as determined by either echocardiography (ECHO) or multigated acquisition (MUGA) scanning. 10. Woman of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 2 weeks prior to treatment. 11. Men and WOCBP must agree to use acceptable contraceptive methods for the duration of time on the study and continue to use acceptable contraceptive methods for at least 6 months from the last dose of bevacizumab or 2 months after the last dose of ompenaclid, whichever is longer. 12. Provides signed informed consent prior to initiation of any study-specific procedures or treatment. 13. Able to adhere to the study visit schedule and other protocol requirements, including follow-up for survival assessment Exclusion Criteria: 1. Persistent clinically significant toxicities (Grade ≥ 2) from previous anticancer therapy. Excluded are Grade 2 chemotherapy-related neuropathy and alopecia which are permitted and Grade 2 laboratory abnormalities if they are not associated with symptoms, are not considered clinically significant by the Investigator, or can be managed with available medical therapies. 2. CRC with histology (or component of histology) consistent with small cell, neuroendocrine, or squamous carcinoma, or lymphoma. 3. Received treatment with chemotherapy, external-beam radiation, or other systemic anticancer therapy within 14 days prior to study therapy administration (42 days for prior nitrosourea or mitomycin-C). 4. Received treatment with an investigational systemic anticancer agent within 5 half lives of the investigational systemic therapy or within 28 days, whichever is shorter prior to Study Drug administration. 5. Has an additional active malignancy that may confound the assessment of the study endpoints. Patients with a past cancer history with substantial potential for recurrence must be discussed with the Medical Monitor before study entry. Patients with the following concomitant neoplastic diagnoses are eligible: non-melanoma skin cancer, carcinoma in situ (including transitional cell carcinoma, cervical intraepithelial neoplasia, and melanoma in situ), organ-confined prostate cancer with no evidence of progressive disease.

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Conditions

The condition(s) this trial relates to.

colonic neoplasm colorectal cancer colorectal neoplasm malignant colon neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer Metastatic colon cancer

Contacts and locations

Locations

  • Antwerp University Hospital

    Antwerp, 2650, Belgium

  • CHU Hôpital Jean Minjoz

    Besançon, 25000, France

  • CHU Nantes -hopital hotel Dieu

    Nantes, Loire-Atlantique, 44093, France

  • CHU de Liège University hospital in Liège

    Liège, 4000, Belgium

  • Centre Georges-François Leclerc

    Dijon, 21000, France

  • Grand Hoptial De Charleroi

    Charleroi, 6000, Belgium

  • Groupe Hospitalier Paris Saint Joseph - Oncologie

    Paris, 75074, France

  • Hopital Prive des Cotes d'Armor

    Plérin, 22190, France

  • Hospital Clinico De Valencia

    Valencia, 46010, Spain

  • Hospital Clinico Universitario De Valencia

    Valencia, 46010, Spain

  • Hospital Puerta de Hierro Majadahonda

    Madrid, 28222, Spain

  • Hospital Puerta de Hierro Majadahonda

    Majadahonda, 28220, Spain

  • Hospital Universitari Vall D Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Reina Sofía

    Córdoba, 14004, Spain

  • Hospital Universitario Virgen de Valme

    Seville, 41014, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08025, Spain

  • Hospital del Mar

    Barcelona, 08003, Spain

  • Imelda Ziekenhuis

    Bonheiden, Antwerpen, 2820, Belgium

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Institut Jules Bordet

    Anderlecht, Belgium

  • Institut Paoli-Calmettes

    Marseille, 13009, France

  • Institut de Cancerologie de l'Ouest

    Saint-Herblain, 44805, France

  • UZ Brussel

    Brussels, 1090, Belgium

  • UZ Leuven

    Leuven, 3000, Belgium

  • Universite Catholique de Louvain (UCL) - Cliniques Universitaires Saint-Luc

    Woluwe-Saint-Lambert, Brussels Capital, 1200, Belgium

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