Study of rSIFN-co for Patients With Advanced Solid Tumors
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.
Timeline
- Start
- 2016-01
- Primary completion
- 2024-11
- Completion
- 2024-11
Outcome
Outcome not reported
Stopped: “Protocol has been amended and the Protocol amendment of Phase II was approved by the US FDA on Nov 2024 through SN0028.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Interferon Alfacon-1 | Protein / enzyme biologic | — | — |