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Study of rSIFN-co for Patients With Advanced Solid Tumors

NCT02464007 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-02-25

No results posted yet for this study

Summary

In this EffTox dose escalation study, up to 3 dose levels will be tested. The optimal dose (OD) of rSIFN-co will be determined using the EffTox design. Additional subject cohorts will not be enrolled until all subjects at the current dose level complete 28 days without DLT. The optimal dose (OD) will be determined by evaluation of safety in each cohort and disease response by RECIST 1.1 at 8 weeks. Once the OD is determined, enrollment will continue until at least 9 subjects total are accrued at the OD. Pharmacokinetics of rSIFN-co will be conducted for all tested dose levels to characterize dose proportionality.

Conditions

  • Malignancies Including Melanoma, Kidney, Lung, Colorectal, Prostate, Neuroendocrine Tumor

Interventions

BIOLOGICAL

rSIFN-co

Artificial recombinant super-compound interferon (rSIFN-co) is a product of patented technological research made possible through protein modulation by spatial conformation control technology, and was developed by Sichuan Huiyang Life Science and Technology Corporation.

Sponsors & Collaborators

  • Medelis Inc.

    collaborator INDUSTRY

  • Sichuan Huiyang Life Science and Technology Corporation

    lead INDUSTRY

Principal Investigators

  • Guangwen Wei · Superlab

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2024-11-30
Completion
2024-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02464007 on ClinicalTrials.gov