Dose-finding Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SNB-101(SN-38) in Patients With Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Breast Cancer
- Colorectal Cancer
- Gastric Cancer
- Head and Neck Cancer
- Ovarian Cancer
- Pancreas Cancer
- Small Cell Lung Cancer
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: 1-6 cohorts, dose escalation method according to modified accelerated titration designMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 19 years and 125 years
- Gender
- Both males and females
Description
Each participant will undergo a screening period, a treatment period, and a follow-up period. Participants will be followed until death, withdrawal of consent, or end of study, whichever occurs first. During the treatment period, participants will receive SNB-101 (dose range: 5 mg/m2 to 50 mg/m2) in...
Each participant will undergo a screening period, a treatment period, and a follow-up period. Participants will be followed until death, withdrawal of consent, or end of study, whichever occurs first. During the treatment period, participants will receive SNB-101 (dose range: 5 mg/m2 to 50 mg/m2) intravenously on day 1 and day 15 of each 28 day cycle. Dose reductions are permitted after the DLT observation period, which occurs during the first 28 days of treatment (cycle 1). Participants may permanently or temporarily (at the investigator's discretion) discontinue SNB-101. If a participant experiences a DLT or unacceptable toxicity, SNB-101 treatment should be interrupted until the observed toxicity returns to baseline or ? grade 1 toxicity. The start of the next cycle can be delayed up to 2 weeks at the investigator's discretion.
Tracking Information
- NCT #
- NCT04640480
- Collaborators
- Not Provided
- Investigators
- Study Chair: Joohang Kim, Dr CHA Medical Center at Bundang
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