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New drug cocktail aims to wipe out hidden colorectal cancer cells

NCT ID NCT07071961

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 28, 2026 · Updated 3 times

Summary

This phase 2 trial tests two drugs, regorafenib and lorigerlimab, in people with high-risk colorectal cancer who have no visible tumors but still have cancer DNA in their blood after standard treatment. The goal is to see if the combination can clear these hidden cancer cells and improve outcomes. Only 16 participants are enrolled, and the study is currently on hold.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
regorafenib and lorigerlimab
What this could lead to
If successful, this combination could help eliminate remaining cancer cells in high-risk colorectal cancer patients, potentially preventing recurrence.
What could go wrong
This is a small, early-phase trial (16 participants) that is currently suspended. The drugs may cause significant side effects, and the approach may not work for all patients.

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

About 16 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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.

Eligibility Criteria * Histological confirmation of CRC * Post-R0 resection of stages II, III, or IV CRC and all planned adjuvant therapies have been completed. * No evidence of radiographic disease within 28 days (before or after) of a positive ctDNA assay * Evident MRD as defined by positive ctDNA assay. Participants may be identified for enrollment with any Clinical Laboratory Improvement Amendments (CLIA)-certified ctDNA assay for MRD. MRD status will be confirmed with the Signatera assay prior to initiation of therapy (unless the prior testing was also done with Signatera in which case this test would not require confirmation) * Adequate organ and marrow function as defined below: * Absolute neutrophil count: ≥1,000/mcL * Platelets: ≥100,000/mcL * Total bilirubin ≤1.5 x the upper limit of normal (ULN). Total bilirubin (≤3 x ULN) is allowed if Gilbert's syndrome is documented. * AST(SGOT)/ALT(SGPT): ≤3 × institutional ULN (≤5 x ULN for participants with liver involvement of their cancer). * Creatinine clearance ≥40 mL/min. Creatinine clearance (Clcr) can either be measured in a 24-hour urine collection or estimated by the Cockcroft-Gault equation as follows: Clcr (mL/min) = \[(140 - age) x (weight in kg) ÷ \[72 x (serum creatinine in mg/dL)\] \[0.85 if female\] * ECOG performance status (PS) of 0 or 1 * Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of regorafenib in these participants, children \<18 years of age are excluded from this study. * Able to understand and is willing to sign a written informed consent document. * The effects of RELO on the developing human fetus are unknown. For this reason and because regorafenib appears to be teratogenic in animal models, women of child-bearing potential (refer to MDA Policy CLN 1114) must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry, for the duration of study participation and for at least 4 months after the last dose. This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: O Postmenopausal (no menses in greater than or equal to 12 consecutives months). * History of hysterectomy or bilateral salpingo-oophorectomy. * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal * range, who have received Whole Pelvic Radiation Therapy). * History of bilateral tubal ligation or another surgical sterilization procedure.) Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice, however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of administration Exclusion Criteria * Concurrent treatment with drug with which the interactions are considered clinically significant by investigator (as outlined in section 0). Major surgical procedure or significant traumatic injury within 21 days before start of study medication. Note: If participants received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy * Grade 2 or higher peripheral neuropathy per CTCAE v5.0. * Systemic therapy with immunosuppressive agents within 7 days or use of any investigational drug within 28 days before the start of trial treatment except for participants who may be receiving low dose prednisone (specifically receiving ≤10 mg prednisone or equivalent within 7 days of treatment initiation). * Prior exposure to any immune checkpoint blockade agent or any other immunomodulatory agent used for antineoplastic therapy for mCRC. * Previous malignant disease (other than the target malignancy to be investigated in this trial) within 3 years prior to study treatment initiation. * Receipt of any organ transplantation, including allogeneic stem cell transplantation (exception: transplants that do not require immunosuppression, such as hair transplant). * Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent. The study will allow replacement therapy with thyroxine, insulin or physiologic corticosteroid replacement therapy for autoimmune conditions that are well-controlled. * Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 NCICTCAE v5.0), any history of anaphylaxis, or recent (within 5 months) history of uncontrolled asthma. * Clinically significant cardiovascular/cerebrovascular disease as follows: cerebral vascular accident/stroke (\<6 months prior to enrollment), myocardial infarction (\<6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification Class \>II), myocarditis, or serious cardiac arrhythmia. * Clinically relevant diseases (for example, inflammatory bowel disease) and / or uncontrolled medical conditions, which, in the opinion of the Investigator, might impair the subject's tolerance or ability to participate in the trial. * Failure to recover from any other toxicity (other than immune-related toxicity) related to previous anticancer treatment to ≤ Grade 2 per CTCAE v5.0. * Receipt of a live-virus vaccine within 30 days prior to first dose of study drug (seasonal flu vaccines that do not contain live virus are permitted). Patient should refrain to receive live-virus vaccines for 120 days following the last dose of lorigerlimab. * Evidence of any serious bacterial, viral (active HIV, HCV or HBV), parasitic, or systemic fungal infections within the 30 days prior to the first dose of study drug. * Subject is pregnant or breast feeding or planning to become pregnant while enrolled in the study, up to the final EOT visit. * History of (non-infectious) pneumonitis that required steroids, ongoing pneumonitis, or history of interstitial lung disease. * History of GI perforation or GI bleeding within 4 weeks, significant diverticulitis or flare within 4 weeks, and acute pancreatitis within 4 weeks. * Grade \> 3 (per CTCAE v5.0) proteinuria (\> 3.5 g/24 hours) * Grade \> 3 (per CTCAE v5.0) hypertension (systolic blood pressure \> 160 or diastolic blood pressure \> 100). * Evidence or history of bleeding diathesis or coagulopathy within 6 months of start of treatment. Subjects with clinically significant thrombotic, embolic, venous, orarterial events, deep vein thrombosis or pulmonary embolism within 6 months of start of treatment. Participants with incidental findings that have started anticoagulation and are stable are allowed. * Ongoing infection \> Grade 2 NCI-CTCAE v5.0. * Symptomatic metastatic brain or meningeal tumors. * Presence of a non-healing wound, non-healing ulcer, or bone fracture. * Major surgical procedure or significant traumatic injury within 28 days before start of study medication * Renal failure requiring hemodialysis or peritoneal dialysis.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.