NCT03131765

Dose Escalation and Cohort Expansion Study of YS-ON-001 in Patients With Advanced Solid Tumors

Phase 1, Open Label, Dose Escalation and Cohort Expansion Study of YS-ON-001 in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Yisheng Biopharma (Singapore) Pte. Ltd. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Phase 1 study evaluating the safety and tolerability of YS-ON-001 in patients with advanced solid tumors who have limited available treatment options, and exploratory evaluation of the pharmacological effect and efficacy of YS-ON-001. The study will be conducted in two parts: dose escalation and cohort expansion

Detailed description

This is an open-label, Phase 1 study of YS-ON-001 vaccine administered intramuscularly (IM) as a single agent to patients with advanced solid tumors. Patients are eligible if they are refractory, resistant or intolerant to prior therapies.The study will assess YS-ON-001 administered as a single agent, three times per week for 21-days with 1 week wash out period (28 days as 1 cycle) for 12 cycles in a continuous regimen. A dose escalation design will be applied in cohorts of 3-6 patients in Part I of the study. The starting dose will be 2ml (3 times/ week). Once the recommended phase II dose (RP2D) is established, the cohort will be expanded with at least 10 additional patients to further characterize the safety and tolerability at RP2D with specific tumour types, Breast cancer and Liver Cancer Treatment with YS-ON-001 may be continued for up to 12 cycles or until disease progression or if patient is withdrawn or unacceptable toxicity occurs. Patients who complete 12 cycles of treatment will be considered to have completed the trial. Patients who continue to benefit from treatment after 12 cycles may have the option to continue treatment upon agreement between the investigator and sponsor, and pending study drug availability.

Conditions

• Cancer

Interventions

Type	Name	Description
BIOLOGICAL	YS-0N-001	Cancer vaccine

Timeline

• Start date: 2017-04-20
• Primary completion: 2019-12-15
• Completion: 2019-12-16
• First posted: 2017-04-27
• Last updated: 2023-12-05

Locations

1 site across 1 country: Singapore