Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-28 @ 4:56 PM
Study NCT ID:
NCT07170592
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-29
First Post:
2025-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 1 Study of OTS-412 (Recombinant Oncolytic Vaccinia Virus) in Treatment-refractory Solid Tumor Patients
Sponsor:
Bionoxx Inc.
Organization:
Study Overview
Official Title:
A Phase 1 Study of OTS-412 (Recombinant Oncolytic Vaccinia Virus) in Combination With Hydroxyurea or Hydroxyurea/Atezolizumab in Treatment-refractory Solid Tumor Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
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 clinical trial aims to determine whether the administration of the investigational drug OTS-412, OTS-412 in combination with hydroxyurea or hydroxyurea/atezolizumab is safe and effective for patients with various types of cancer.
Detailed Description:
The primary objective of this study is:
* to evaluate the safety of OTS-412 monotherapy, combination therapy of OTS-412 and hydroxyurea, or combination therapy of OTS-412, hydroxyurea, and atezolizumab
* to find an optimal dosage of hydroxyurea when used in combination with OTS 412. Hydroxyurea is currently used at dosages of 15-35 mg/kg/day for certain conditions, and the optimal dosage when combined with the oncolytic virus will be determined within this range.
* to find an optimal dosage of OTS-412 when used in combined with hydroxyurea and atezolizumab.
The secondary objectives include evaluating anti-tumor effects, immune responses, and pharmacokinetics (PK) of OTS-412 in blood over time after administration.
This study focuses on various solid tumors that are resistant to standard therapies, particularly immune checkpoint inhibitors alone or in combination with other therapies.
* to evaluate the safety of OTS-412 monotherapy, combination therapy of OTS-412 and hydroxyurea, or combination therapy of OTS-412, hydroxyurea, and atezolizumab
* to find an optimal dosage of hydroxyurea when used in combination with OTS 412. Hydroxyurea is currently used at dosages of 15-35 mg/kg/day for certain conditions, and the optimal dosage when combined with the oncolytic virus will be determined within this range.
* to find an optimal dosage of OTS-412 when used in combined with hydroxyurea and atezolizumab.
The secondary objectives include evaluating anti-tumor effects, immune responses, and pharmacokinetics (PK) of OTS-412 in blood over time after administration.
This study focuses on various solid tumors that are resistant to standard therapies, particularly immune checkpoint inhibitors alone or in combination with other therapies.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?: