rSIFN-co for Cancer

No longer recruiting at 3 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Sichuan Huiyang Life Science and Technology Corporation

Must not be taking: Steroids, Antidepressants

Disqualifiers: Autoimmune disorders, Uncontrolled diabetes, HIV, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called rSIFN-co, a type of interferon therapy, to determine the best dose for individuals with certain advanced cancers, such as melanoma, kidney, or lung cancer, that have not responded to standard treatments. The study aims to identify the safest and most effective dosage by gradually increasing the dose and monitoring participants' reactions. It suits individuals with measurable tumors who have tried treatments like chemotherapy but still experience cancer progression. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

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. However, you cannot have had chemotherapy, immunotherapy, or certain other treatments within 4 weeks before starting the study drug.

Is there any evidence suggesting that rSIFN-co is likely to be safe for humans?

Research has shown that rSIFN-co may effectively treat solid tumors. In studies, it performed better against cancer cells than interferon α-2b, a similar treatment. Importantly, rSIFN-co also caused fewer side effects, making it potentially easier for patients to tolerate. Trials have tested it safely in humans, suggesting it is generally well-tolerated. While more research is needed to confirm its safety at different doses, early results are promising. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about rSIFN-co for cancer because it offers a novel approach by utilizing a recombinant form of interferon, which may enhance the body's immune response to target cancer cells more effectively. Unlike standard treatments like chemotherapy or radiation, which directly attack cancer cells but can damage healthy cells, rSIFN-co aims to boost the immune system to fight cancer more precisely. This treatment's potential for fewer side effects and enhanced immune activation is what makes it stand out from traditional options.

What evidence suggests that rSIFN-co might be an effective treatment for cancer?

Research has shown that rSIFN-co, the investigational drug in this trial, functions like interferon-alpha but fights cancer cells more effectively and causes fewer side effects. In early studies, rSIFN-co proved more effective against tumors than standard interferon treatments. Another study found that patients using rSIFN-co improved faster than those using traditional interferon-alpha. These findings suggest that rSIFN-co could be a promising treatment for solid tumors. ^{1 3 5 6 7}

Who Is on the Research Team?

Guangwen Wei

Principal Investigator

Superlab

Are You a Good Fit for This Trial?

Adults with advanced solid tumors like melanoma, kidney, lung, colorectal carcinoma, prostate cancer, and neuroendocrine tumor that's worsening despite standard therapy. They must have measurable disease per RECIST 1.1 criteria, good organ function (bone marrow, liver, kidneys), ECOG performance status ≤1 (able to carry out light activity), and agree to use contraception if of childbearing potential.

Inclusion Criteria

Has read, understood and signed the informed consent form (ICF) approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC)

Must be willing and able to comply with study visits and procedures

My cancer is one of the specified types and is getting worse despite treatment.

Exclusion Criteria

I regularly use steroid medication.

Abnormalities on 12-lead electrocardiogram considered clinically significant

Has any condition that might jeopardize the safety of the subject or interfere with protocol compliance

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of rSIFN-co to determine the optimal dose (OD) using the EffTox design

8 weeks

Weekly visits for dose administration and monitoring

Pharmacokinetics

Pharmacokinetics of rSIFN-co are conducted to characterize dose proportionality

Concurrent with dose escalation

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• rSIFN-co

Trial Overview The trial is testing different doses of a drug called rSIFN-co in patients with various types of advanced cancers. It uses an 'EffTox' method to find the best dose by looking at both effectiveness and safety over time before deciding on the optimal dose for further study.

How Is the Trial Designed?

Group I: sSIFN-co Experimental Treatment 1 Intervention

Dose escalation of rSIFN-co

Who Is Running the Clinical Trial?

Sichuan Huiyang Life Science and Technology Corporation

Lead Sponsor

Trials

3

Recruited

240+

Medelis Inc.

Industry Sponsor

Trials

7

Recruited

480+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02387307

A Study of rSIFN-co in Subjects With Advanced Solid Tumors rSIFN-co is a drug developed by Sichuan Huiyang Life Science and Technology Corporation for the treatment of solid tumors especially in non-small cell lung ...

2. immuno-oncologynews.com immuno-oncologynews.com/rsifn-co/

rSIFN-co The new molecule has IFN-alpha's mode of action, but is more effective against cancer cells and has fewer side effects. rSIFN-co in clinical ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5455684/

Phase III Randomized Study of 4 Weeks of High-Dose ... To test the efficacy of 4 weeks of intravenous (IV) induction with high-dose interferon (IFN) as part of the Eastern Cooperative Oncology Group regimen compared ...

4. aacrjournals.org aacrjournals.org/cancerimmunolres/article/4/1_Supplement/A027/468225/Abstract-A027-A-phase-I-open-label-non-randomized

Abstract A027: A phase I open-label, non-randomized study of ... rSIFN-co displayed greater anti-tumor activity in solid tumors compared to interferon α-2b in pre-clinical studies. Methods: Patients with advanced ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7906612/

Effect of a genetically engineered interferon-alpha versus ... The time to clinical improvement in the rSIFN-co group was statistically shorter than that in the interferon-alpha group (median, 11.5 days vs 14.0 days).

6. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)58684-7/fulltext

A phase I open-label, non-randomized study of ... rSIFN-co displayed greater anti-tumor activity in solid tumors compared to interferon α-2b in pre-clinical studies. Methods. Patients with advanced malignancies ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0923753419586847

A phase I open-label, non-randomized study of ... rSIFN-co displayed greater anti-tumor activity in solid tumors compared to interferon α-2b in pre-clinical studies. Methods Patients with advanced malignancies ...