Ignite Creation Date:
2025-12-24 @ 12:53 PM
Ignite Modification Date:
2025-12-27 @ 6:59 PM
Study NCT ID:
NCT05576961
Status:
RECRUITING
Last Update Posted:
2024-01-23
First Post:
2022-09-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of RX-af01 Combined With PD-1 Antibody
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
Official Title:
Safety and Efficacy of Bacterial Strain RX-af01 Combined With PD-1 Antibody in Patients With Refractory Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-01
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 phase I trial evaluates the effects of RX-af01 in combination with toripalimab (PD-1 antibody), in treating patients with refractory advanced solid tumors, including melanoma, nasopharyngeal squamous carcinoma, esophageal squamous cell carcinoma, gastric adenocarcinoma, renal cell carcinoma, et al. RX-af01 is a kind of anti-tumor intestinal bacteria developed by our research group. Its main components are symbiotic bacteria from human intestine - Alisipes finegoldii (A. finegoldii.), which is a Gram negative anaerobic bacteria. Our previous research shows that A finegoldii. can significantly enhance the anti-tumor activity of PD-1 antibody in multiple mouse tumor models. Mechanism research shows that A finegoldii. can increase the infiltration of CD4 and CD8 positive immune cells in the tumor microenvironment, and enhances the anti-tumor activity of immune cells. The primary aim of this study is to explore the efficacy and safety of RX-af01 combined with PD-1 antibody in refractory advanced solid tumors.
Detailed Description:
This is a phase Ib study to evaluate the effects of RX-af01 in combination with toripalimab (PD-1 antibody), in treating patients with refractory advanced solid tumors, including melanoma, nasopharyngeal squamous carcinoma, esophageal squamous cell carcinoma, gastric adenocarcinoma, renal cell carcinoma, et al. This study will include 3 chorts. Cohort 1 uses the regular dose of RX-af01. Cohort 2 uses a high dose of RX-af01 which is 5 times of the regular dose of RX-af01. Cohort 3 uses a mixed bacteria including RX-af01, Bifidobacterium longum RX02 and Ligilactobacillus salivarius RX02.
Primary endpoint:
To determine the safety and efficacy of bacterial strain RX-af01 in combination with toripalimab in refractory advanced solid tumors.
Secondary endpoint:
1. Progression free survival (PFS)
2. Overall survival (OS)
3. Duration of response (DOR)
4. Tumor microenvironment
5. Changes in flora species/abundance
Primary endpoint:
To determine the safety and efficacy of bacterial strain RX-af01 in combination with toripalimab in refractory advanced solid tumors.
Secondary endpoint:
1. Progression free survival (PFS)
2. Overall survival (OS)
3. Duration of response (DOR)
4. Tumor microenvironment
5. Changes in flora species/abundance
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?: