Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT04612504
Status:
UNKNOWN
Last Update Posted:
2023-02-02
First Post:
2020-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
SynOV1.1 Intratumoral Injection Study
Sponsor:
Beijing Syngentech Co., Ltd.
Organization:
Study Overview
Official Title:
An Open-label Phase I Study to Evaluate the Safety, Tolerability and Efficacy of SynOV1.1 Recombinant Oncolytic Adenovirus Injection as Monotherapy in Participants With Locally Advanced or Metastatic Solid Tumors
Status:
UNKNOWN
Status Verified Date:
2023-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase I, open-label, multicenter study to characterize safety and tolerability, evaluate biodistribution, biological effects and immunogenicity, and evaluate the preliminary clinical efficacy of SynOV1.1 in participants with AFP positive solid tumors.
Detailed Description:
Part 1 ( single dose escalation) is designed to determine the pharmacodynamics of SynOV1.1 as well as type and severity of toxicity based on safety and tolerability assessments. 3 dose level (3 × 10\^11 Vp, 1 × 10\^12 Vp, 3 × 10\^12 Vp) will be evaluated.
Part 2 (multiple dose escalation) is designed to determine the pharmacodynamics of SynOV1.1 as well as type and severity of toxicity based on safety and tolerability assessments. Participants will receive administration bi weekly. 2 dose level will be evaluated based on part 1 result.
Part 2 (multiple dose escalation) is designed to determine the pharmacodynamics of SynOV1.1 as well as type and severity of toxicity based on safety and tolerability assessments. Participants will receive administration bi weekly. 2 dose level will be evaluated based on part 1 result.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: