Regorafenib + Lorigerlimab for Rectal Cancer

Overseen By Alisha H Bent, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

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

Disqualifiers: Metastatic disease, Autoimmune 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: 3

Duration: 12 weeks

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, to determine their safety and effectiveness in treating certain types of rectal cancer. It targets patients whose rectal cancer has recurred or returned locally after initial therapy. Suitable candidates have rectal cancer that has regrown or returned after treatment and are willing to undergo a biopsy for confirmation. The study aims to understand how these drugs work together to treat this specific cancer. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial protocol does not clearly specify if you need to stop taking your current medications. However, you cannot take certain medications like strong inhibitors and inducers of CYP3A4, certain anticoagulants, or herbal remedies that might interact with the study drugs. 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 treatment is likely to be safe for humans?

Past studies have tested regorafenib and lorigerlimab in people. The FDA has already approved regorafenib for other cancers, such as colorectal cancer, providing some safety information. Patients taking regorafenib have reported side effects, which are generally manageable. Common side effects include fatigue, painful redness and swelling of the hands and feet, and high blood pressure.

Lorigerlimab remains under study, but early findings suggest it is generally well-tolerated. Some patients have experienced mild to moderate side effects, such as fatigue and nausea, during trials.

The combination of these two treatments is still under evaluation. Since this study is in phase 2, earlier studies have shown the combination's safety to be acceptable. However, new side effects could still appear. It is important to discuss any treatment safety concerns with a doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Regorafenib and Lorigerlimab for rectal cancer because it introduces a novel approach to treatment. Unlike standard chemotherapy and radiation, Regorafenib is a targeted therapy that inhibits tumor growth by blocking specific proteins involved in cancer cell proliferation. Lorigerlimab, meanwhile, is an innovative immunotherapy that enhances the immune system's ability to attack cancer cells. Together, this combination not only targets the cancer directly but also boosts the body's natural defenses, offering a potentially more effective and comprehensive treatment option for patients.

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

Research has shown that using regorafenib and lorigerlimab together may help treat certain cancers. In this trial, participants will receive a combination of these two drugs. Similar studies have demonstrated that this combination can shrink tumors in some patients. Regorafenib blocks proteins that cancer cells need to grow, while lorigerlimab is an antibody that aids the immune system in fighting cancer. Early findings suggest this combination might be effective for patients whose rectal cancer has returned or progressed after other treatments. Although more research is needed, the initial results are promising for this specific type of cancer. ^{1 2 3 4 6}

Who Is on the Research Team?

Alisha H Bent, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with a specific type of rectal cancer that has come back or started growing again locally after total neoadjuvant therapy (TNT). Participants should have tumors with particular molecular features known as pMMR/MSS.

Inclusion Criteria

Ability to swallow and retain pills

Willingness to use contraception as specified

No known active pregnancy or nursing

Exclusion Criteria

Known positivity to HIV or active AIDS

Known active pregnancy or nursing

Known hypersensitivity to recombinant proteins, polysorbate 80, or any excipient contained in the Lorigerlimab drug formulation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive regorafenib 90mg PO daily on D1-21 Q28 days and lorigerlimab 6mg/kg IV Q28 days for 3 months

12 weeks

3 visits (in-person, every 4 weeks)

Surgical Resection

Surgical resection is performed to assess major pathological response

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lorigerlimab
• Regorafenib

Trial Overview The study is testing the combination of two drugs, Regorafenib and Lorigerlimab, to see how safe and effective they are together in treating localized recurrent or regrowing rectal cancer. It's an early-phase trial where all participants receive the same treatment.

How Is the Trial Designed?

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

Participants will be treated with the combination of regorafenib 90mg PO daily on D1-21 Q28 days and lorigerlimab 6mg/kg IV Q28 days for 3 months.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

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

MacroGenics

Industry Sponsor

Trials

51

Recruited

5,400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07223567

Phase II Trial of Regorafenib Plus Lorigerlimab in Patients ... This is a prospective single-center, single-arm, open-label, phase II study evaluating the safety, activity, and efficacy of regorafenib in ...

2. 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 ...

3. withpower.com withpower.com/trial/phase-2-rectal-neoplasms-3-2026-e45d5

Regorafenib + Lorigerlimab for Rectal Cancer This trial is for patients with a specific type of rectal cancer that has come back or started growing again locally after total neoadjuvant therapy (TNT).

4. ichgcp.net ichgcp.net/amp/clinical-trials-registry/NCT07223567

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

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12564126/

Real-World Evidence of Regorafenib Dose Escalation ... This analysis demonstrates that regorafenib dose escalation is a feasible and well-tolerated strategy for patients with refractory mCRC, ...

6. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-12421-4

Real-world dosing of regorafenib and outcomes among ... Real-world dosing of regorafenib and outcomes among patients with metastatic colorectal cancer: a retrospective analysis using US claims data.