NCT02464007

Study of rSIFN-co for Patients With Advanced Solid Tumors

A Phase 1 Study of rSIFN-co for Subjects With Advanced Solid Tumors Where Interferons Are Known to Have Demonstrated Antitumor Activity

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Sichuan Huiyang Life Science and Technology Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The initial cohort will be 3 subjects. Escalation to the next dose will continue unless a subject experiences a DLT, at which time a cohort will be expanded to up to 6 subjects. Provided there is only one DLT in that cohort, the dose will be escalated. However, if there are 2 DLTs in that cohort of up to 6 subjects, previous dose level will be expanded to total of 9 subjects. If none of the dose levels are acceptable at study completion (i.e., \>33% of subjects experiencing a DLT), an OD will not be identified, and the drug does not warrant further investigation.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-01-01
• Primary completion: 2024-11-01
• Completion: 2024-11-01
• First posted: 2015-06-08
• Last updated: 2025-02-25

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study