Regorafenib + Lorigerlimab for Colorectal Cancer

Overseen By Van Morris, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Corticosteroids, Immunosuppressives, Anticoagulants, others

Disqualifiers: Extrapulmonary metastases, Autoimmune diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of two drugs, regorafenib and lorigerlimab (an experimental treatment), to treat colorectal cancer that has spread only to the lungs. The goal is to determine if these drugs can shrink tumors before surgery. Participants must have colorectal cancer confirmed by a doctor and no other organ involvement besides the lungs. This research could lead to new treatment options for those with lung-limited metastatic colorectal cancer. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications, but it does mention that you should avoid certain drugs like strong inhibitors and inducers of CYP3A4 activity and therapeutic anticoagulation with Vitamin-K antagonists. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the combination of regorafenib and lorigerlimab is still under investigation for safety and tolerability. Previous studies found that regorafenib, when used alone for colorectal cancer, can cause side effects such as tiredness, redness and swelling of the hands and feet, and high blood pressure. However, patients generally manage these side effects.

For lorigerlimab, early reports indicate ongoing testing for side effects, but detailed safety information is not yet available. As this trial is in its early stages, the main focus is on assessing treatment tolerability, with close monitoring for any negative effects.

For those considering joining the trial, past trials have not shown serious safety issues. However, discussing any concerns with the trial team or a doctor is important, as they can provide more detailed information based on the latest findings. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for colorectal cancer?

Researchers are excited about Regorafenib combined with Lorigerlimab for colorectal cancer because it targets the disease in a novel way. Most treatments for colorectal cancer, such as chemotherapy and targeted therapies like bevacizumab or cetuximab, focus on inhibiting cancer cell growth or cutting off blood supply to tumors. However, Lorigerlimab, a monoclonal antibody, works by enhancing the body's immune response to attack cancer cells more effectively. This unique mechanism, alongside Regorafenib's ability to inhibit multiple tumor growth pathways, offers a promising new angle for tackling colorectal cancer, potentially improving outcomes for patients who have limited options.

What evidence suggests that this trial's treatments could be effective for colorectal cancer?

Studies have shown that regorafenib can extend the lives of patients with metastatic colorectal cancer (mCRC). In one study, patients taking regorafenib lived for an average of 8.8 months. Regorafenib is already used to treat mCRC, particularly when other treatments fail. Lorigerlimab, a newer drug, aids the immune system in fighting cancer. Early research suggests that combining regorafenib and lorigerlimab, as tested in this trial, might reduce cancer markers in the blood over six months. These findings indicate that this combination could be promising for colorectal cancer that has spread to the lungs. ^{1 2 3 4 6}

Who Is on the Research Team?

Van Morris, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults with a specific type of colorectal cancer that has spread to the lungs but not elsewhere, and who are candidates for lung surgery. They must have good organ function, be able to take pills, and agree to use contraception if needed. Exclusions include those with certain health conditions or treatments within specified time frames before the trial.

Inclusion Criteria

Willingness to use contraception if applicable

I have at least one lung lesion that can be measured.

My cancer in the colon or rectum has been confirmed by lab tests.

Exclusion Criteria

I have a history of certain diseases or conditions.

I have a wound or ulcer that is not healing.

I am scheduled for treatment with cancer-fighting drugs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive regorafenib plus lorigerlimab as neoadjuvant therapy

12 weeks

3 visits (in-person, every 4 weeks)

Surgical Resection

Participants undergo surgical resection to assess major pathological response

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lorigerlimab
• Regorafenib

Trial Overview The study tests Regorafenib combined with Lorigerlimab as pre-surgery treatment for patients whose colorectal cancer has metastasized only to their lungs. The goal is to provide evidence for future trials on this combination therapy's effectiveness in such cases.

How Is the Trial Designed?

Group I: Treatment with Regorafenib PO + Lorigerlimab IV Q4W Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07137390

Phase Ib/II Trial of Regorafenib Plus Lorigerlimab as ... To assess the major pathological response (MPR) rate following neoadjuvant regorafenib plus lorigerlimab and surgical resection in patients with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11231874/

Efficacy and safety of regorafenib in the treatment ... The mCRC patients who received a third-line regorafenib treatment demonstrated a median overall survival (mOS) of 8.8 months and a median ...

3. withpower.com withpower.com/trial/phase-2-colorectal-neoplasms-1-2026-d2636

Regorafenib + Lorigerlimab for Colorectal Cancer This trial is for adults with a specific type of colorectal cancer that has spread to the lungs but not elsewhere, and who are candidates for lung surgery. They ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07071961

Regorafenib (Reg) and Lorigerlimab (Lor), RELO Regimen ... To determine the 6-month circulating tumor (ctDNA) clearance rate following 6 months of therapy with RELO regimen in patients with colorectal ...

5. cancernetwork.com cancernetwork.com/view/effectiveness-toxicity-and-survival-predictors-of-regorafenib-in-metastatic-colorectal-cancer-a-multicenter-study-of-routinely-collected-data

Effectiveness, Toxicity, and Survival Predictors of ... In conclusion, in our study of routinely collected data of 90 patients with mCRC, treatment with regorafenib was associated with OS outcomes ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12109328/

Safety and Efficacy of Regorafenib and 5-Fluorouracil ... This study highlights that using a combination of regorafenib plus 5-FU can be a potential treatment option for patients with refractory mCRC.