rSIFN-co for Cancer

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

7 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new drug called rSIFN-co. It begins with small groups of patients to determine the safest and most effective dose. The dose is gradually increased, and patients are monitored for serious side effects.

Research Team

Guangwen Wei

Principal Investigator

Superlab

Eligibility Criteria

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)

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

I have had chemotherapy, immunotherapy, surgery, or radiation for cancer before.

Exclusion Criteria

I regularly use steroid medication.

Abnormalities on 12-lead electrocardiogram considered clinically significant

I do not have any severe health or mental conditions that could make this study risky for me.

Timeline

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

Treatment Details

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.

Participant Groups

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+