Regorafenib + Lorigerlimab for Colorectal Cancer

Overseen By Kanwal Raghav, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Immunosuppressants, Immune checkpoint inhibitors

Disqualifiers: Autoimmune disease, Cardiovascular disease, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how regorafenib and lorigerlimab (an experimental treatment) affect tumor DNA in individuals with colorectal cancer who have small amounts of residual cancer after standard treatment. The goal is to determine if these drugs can help reduce or control this minimal residual disease. It suits those who have completed all planned treatments for colorectal cancer, show no visible signs of cancer on scans, but test positive for tumor DNA. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant findings.

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

The trial protocol does not clearly specify if you need to stop taking your current medications. However, it mentions that concurrent treatment with drugs that have significant interactions, as determined by the investigator, may exclude you from participation. 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 has shown that regorafenib, when used alone, is generally safe for treating colorectal cancer and can help patients live longer. Common side effects include tiredness, skin reactions on the hands and feet, and high blood pressure, but these are usually manageable.

Lorigerlimab is less familiar on its own but is being tested with regorafenib. Previous studies have examined the safety of this combination and found it tolerable for most patients. Some side effects reported are similar to those of other cancer treatments, such as tiredness and nausea.

This trial is in Phase 2, indicating that earlier trials have checked its safety, but researchers are still gathering more information. Overall, the combination of regorafenib and lorigerlimab appears promising in terms of safety, but ongoing research will provide more details. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Regorafenib combined with Lorigerlimab for colorectal cancer because it targets the disease in a novel way. Unlike traditional treatments that mainly focus on chemotherapy or targeted therapies against specific cancer pathways, this combination introduces Lorigerlimab, a bispecific antibody that modulates the immune response, alongside Regorafenib, a multi-kinase inhibitor. This dual approach not only attacks the cancer cells directly but also boosts the body's immune system to fight the cancer more effectively. This innovative mechanism has the potential to improve outcomes for patients who have limited options with existing therapies.

What evidence suggests that regorafenib and lorigerlimab might be effective treatments for colorectal cancer?

Studies have shown that regorafenib can help patients with colorectal cancer. For those using regorafenib as a third treatment option, the average survival time was 8.8 months. In this trial, participants will receive a combination of regorafenib and lorigerlimab. Early research on this combination suggests it might remove tiny bits of cancer DNA from the blood after treatment. Researchers are testing this combination to see if it can eliminate small, hidden traces of cancer that might remain after standard treatment. While more information is needed, this approach looks promising for addressing leftover cancer in colorectal cancer patients. ^{1 2 3 4 6}

Who Is on the Research Team?

Kanwal Raghav, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for high-risk colorectal cancer patients who have finished standard treatments but still show signs of microscopic cancer remnants in their blood. Participants should not have any visible tumors on scans.

Inclusion Criteria

Evident MRD as defined by positive ctDNA assay

My colorectal cancer has been confirmed through tissue examination.

I am 18 years old or older.

Exclusion Criteria

I don't have any health issues that would stop me from joining the trial.

I am not taking any medications that could interfere with the trial treatment.

I have moderate to severe numbness, tingling, or pain in my hands or feet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive regorafenib and lorigerlimab for up to 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Lorigerlimab
• Regorafenib

Trial Overview The ReLOAD trial is testing the combination of two drugs, Regorafenib and Lorigerlimab, to see if they can eliminate microscopic cancer traces that remain after initial treatment in colorectal cancer patients.

How Is the Trial Designed?

Group I: RELO in ctDNA+ mCRC Experimental Treatment 2 Interventions

receive regorafenib and lorigerlimab for up to 6 months

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

MacroGenics

Industry Sponsor

Trials

51

Recruited

5,400+

Bayer

Industry Sponsor

Trials

2,291

Recruited

25,560,000+

Founded

1863

Headquarters

Leverkusen, Germany

Known For

Pharmaceutical Innovations

Top Products

Aspirin, Aleve, Yaz, Nexavar

Bill Anderson

Bayer

Chief Executive Officer since 2023

BSc in Chemical Engineering from the University of Texas, MSc in Chemical Engineering and Management from MIT

Michael Devoy

Bayer

Chief Medical Officer since 2014

MD, PhD

Citations

1. 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 ...

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-2026-cc72c

Regorafenib + Lorigerlimab for Colorectal Cancer Trial Overview The ReLOAD trial is testing the combination of two drugs, Regorafenib and Lorigerlimab, to see if they can eliminate microscopic cancer traces ...

4. 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 ...

5. ichgcp.net ichgcp.net/clinical-trials-registry/NCT07223567

Regorafenib and Lorigerlimab in Rectal Cancer ... - ICH GCP This is a prospective single-center, single-arm, open-label, phase II study evaluating the safety, activity, and efficacy of regorafenib in ...

6. onclive.com onclive.com/view/analysis-confirms-safety-of-regorafenib-in-mcrc-among-best-responders

Analysis Confirms Safety of Regorafenib in mCRC Among ... Overall, treatment with regorafenib improved overall survival (OS) by 1.4 months (6.4 vs 5.0 months; HR = 0.77; P = .0052) and progression-free survival (PFS) ...