Nadunolimab + Toripalimab for Colorectal Cancer

Overseen By Jordan Cuevas

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Dan Feng

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: Chemotherapy, Autoimmune disease, HIV, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of immunotherapy treatments, nadunolimab and toripalimab, for patients with a specific type of colorectal cancer unresponsive to chemotherapy. The researchers aim to determine if this treatment is safe, tolerable, and effective in controlling cancer growth. It targets those who have tried standard chemotherapy drugs without success and have at least one measurable tumor. For individuals with colorectal cancer that hasn't improved with previous treatments, this trial might be suitable. 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 therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on chemotherapy within 14 days of starting the trial or on certain immunosuppressive therapies. It's best to discuss your specific medications with the trial team.

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

Research has shown that the combination of nadunolimab and toripalimab is generally safe. In studies with patients who have advanced lung cancer, this treatment was usually well-tolerated. Patients lived longer, even if they had tried similar treatments before. Although specific side effects weren't listed, a "manageable safety profile" indicates that any side effects were not too severe compared to the potential benefits for most patients. As this trial is in the early stages, it aims to further assess safety and identify any serious side effects related to dosage. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Nadunolimab and Toripalimab for colorectal cancer because these treatments work in a novel way compared to standard options like chemotherapy and targeted therapies. Nadunolimab targets and blocks a specific protein involved in tumor growth and immune system evasion, potentially enhancing the body's natural defenses against cancer cells. Toripalimab is an immunotherapy that boosts the immune system's ability to identify and attack cancer cells. Together, these treatments could offer a more effective approach by combining immune system activation with direct tumor inhibition, potentially improving outcomes for patients with colorectal cancer.

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

Research has shown that using the drugs nadunolimab and toripalimab together may help treat certain cancers. One study found that patients with advanced cancer lived for an average of 13.2 months after starting this treatment. This trial will evaluate the combination of nadunolimab and toripalimab specifically for colorectal cancer. Toripalimab has already proven effective in other cancer treatments, enhancing its potential benefits. Although it's still early, these results offer hope for colorectal cancer patients with limited treatment options. ^{1 4 5 6 7}

Who Is on the Research Team?

Dan Feng, MD, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for individuals with metastatic colorectal cancer that hasn't responded to chemotherapy. Participants should have a specific type of tumor (MSS CRC) and be able to receive treatment every 3 weeks for up to a year, unless their disease progresses.

Inclusion Criteria

I am mostly active and can care for myself despite any long-term disabilities.

Patient must be willing and able to provide blood samples (6 heparinized, and two streck tubes, roughly 70 - 80 mL) at the time points indicated in the Study Calendar

I am willing to undergo several needle biopsies of my tumor if it's safe.

Exclusion Criteria

I am allergic to some protein-based medicines like vaccines or antibodies.

I can receive palliative radiotherapy if it's best for me.

Patients may not be receiving any other investigational agents

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1b Treatment

Participants receive a single dose of combination immunotherapy to assess dose-limiting toxicity

3 weeks

1 visit (in-person)

Phase 2 Treatment

Participants receive nadunolimab and toripalimab every 3 weeks for up to 1 year or until disease progression

up to 12 months

Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nadunolimab
• Toripalimab

Trial Overview

The study is testing the combination of two immunotherapy drugs, Nadunolimab and Toripalimab, in patients with advanced colon cancer. It's an early-phase trial looking at safe dosage levels first (Phase 1b), then how well the treatment works (Phase 2).

How Is the Trial Designed?

Group I: Nadunolimab and Toripalimab Experimental Treatment 2 Interventions

Participants will receive the investigational combination of nadunolimab and toripalimab. Treatment will continue for up to 1 year or until disease progression, whichever occurs first.

Who Is Running the Clinical Trial?

Dan Feng

Lead Sponsor

Coherus Oncology, Inc.

Industry Sponsor

Cantargia AB

Industry Sponsor

Trials

6

Recruited

450+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07281716

Combination Immunotherapy for the Treatment of ...

The results will provide important information on the safety and potential efficacy of combining nadunolimab and toripalimab in a population ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12490223/

Toripalimab, bevacizumab, and irinotecan in dMMR/MSI ...

Wang et al. show that toripalimab plus irinotecan and bevacizumab is a safe and active regimen in patients with T4NanyM0 colon cancer or locally ...

3.

adisinsight.springer.com

adisinsight.springer.com/trials/700388786

A Phase 1b/2 Study of Combination Immunotherapy for the ...

Phase 1b/2 open-label study evaluates the safety, tolerability, and efficacy of combination immunotherapy with nadunolimab (anti-IL-1RAP) ...

4.

cancernetwork.com

cancernetwork.com/view/nadunolimab-combo-shows-promising-efficacy-in-advanced-metastatic-pdac

Nadunolimab Combo Shows Promising Efficacy in ...

Across all dose levels, study treatment yielded a median overall survival (OS) of 13.2 months (95% CI, 10.6-15.5) and a survival probability of ...

5.

obis.com

obis.com/reports/esmo24-oncology-report/

ESMO24 Oncology Report

The focus of this report is to describe the different cancer drug modalities which for which the 275 new drugs have been classified as follows: small molecule ( ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12572784/

Neoadjuvant PD-1 blockade with toripalimab with or ...

At the 5-year landmark analysis, the 5-year overall survival rates were 100% (95% CI 100-100) in the combination group and 94% (95% CI 84–99) in ...

7.

cantargia.com

cantargia.com/en/press-releases/cantargia-announces-publication-of-clinical-data-showing-benefit-of-nadunolimab-combination-therapy-in-advanced-lung-cancer

Cantargia announces publication of clinical data showing ...

The trial showed a manageable safety profile and encouraging median survival times, especially in patients with prior treatment with checkpoint ...