Melanoma Clinical Trial
Official title:
A Phase I Open-Label, Non-Randomized, Dose-Escalation Study of rSIFN-co in Subjects With Advanced Solid Tumors and With an Expansion Cohort at Recommended Dose (RD) in Subjects With Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Melanoma, Hepatocellular Carcinoma or Colon Cancer
This is a multicenter, open-label, phase I study of rSIFN-co (3 times a week via subcutaneous injection for 21 days, with 1 week of washout per cycle).
The Dose-Escalation Cohort will consist of the Pretreatment Phase, the Treatment Phase, the
Extension Phase, Discontinuation and Follow-up. The Pretreatment Phase will include a Consent
and Screening Period. The Treatment Phase will consist of the Lead in Period and first 21-day
cycle of treatment during which subjects will be monitored for the development of
dose-limiting toxicity (DLT) following 1 week of washout. The Extension Phase will start from
the start of Cycle 2 with intra-subject dose-escalation performed until discontinuation of
study treatment. Upon discontinuation of study treatment, discontinuation visit assessments
should occur within 7 days of treatment discontinuation or confirmation of discontinuation
criteria. End of treatment information will also be collected for all subjects who
discontinue treatment after completion of cycle 1 treatment. Follow-up visit/final visit
evaluations will be performed 28 (±5 days) days after the last rSIFN-co administration. The
decision to undergo dose-escalation to the next dose level will be based on the safety
information obtained during Cycle 1.
Dose escalation in solid tumors utilizing a "3+3" design with intra-subject dose escalation.
4 dose levels of rSIFN-co are planned for determining the RD. 3-6 subjects will be assigned
to each dose level and followed up for 4 weeks after starting administration in Cycle 1. Each
cohort will be started after the tolerability of that dose level has been confirmed in
subjects with advanced solid tumors. For subjects starting in the lower dose cohorts,
intra-subject dose escalation will be allowed till grade 3/4 toxicity is encountered or
highest dose level (after safety and tolerability are confirmed) TIW is reached. In order to
minimize the risk of allergic reactions, the sponsor has advised a lead-in period starting
from 15μg. When the tolerability of each dose level has been confirmed by the observation of
no DLT among 3 subjects, escalation to the next dose level will occur.
The Expansion Cohort will be initiated at the RD. Depending on the RD, the lead in period
will occur accordingly. After the lead in period, a period from Cycle 1 to the final
administration will be performed as the Treatment Phase during which subjects will undergo a
standardized evaluation for the safety and efficacy of rSIFN-co at the RD. If subjects are
discontinued from the study treatment, discontinuation visit assessments should occur within
7 days of last rSIFN-co administration or confirmation of discontinuation criteria. End of
treatment information will also be collected for all subjects who discontinue treatment after
completion of cycle 1 treatment. Follow-up evaluations will be performed 28 days (±5 days)
after the last rSIFN-co administration.
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