Trials / Unknown
UnknownNCT06178003
the Safety and Efficacy of Intravitreal Injection of Tpdelansbsalbac in Malignant Effusions.
A Phase I/II Clinical Study of the Safety and Efficacy of Intravitreal Injection of Tpdelansbsalbac in the Treatment of Malignant Pleural and Abdominal Effusions
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 65 (estimated)
- Sponsor
- The First Affiliated Hospital of Xinxiang Medical College · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase I/II, open, first-in-human (FIH) study of Transebacillus in Patients with malignant pleural and abdominal effusions. It consists of Phase Ia to determine the Maximum tolerated dose (MTD) or Recommended Phase 2 dose (RP2D) of Transebacillus, and Phase Ib/II to explore and confirm the efficacy, safety and Tolerability.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Tpdelansbsalbac | Tpdelansbsalbac,which is Knockdown of ansB, a gene that expresses L-mentholase secreted into the extracellular region, on the basis of the genetic background of bacterium VNP20009, and construction of an ansB gene-deficient mutant strain, ΔansB. |
Timeline
- Start date
- 2024-02-11
- Primary completion
- 2024-04-01
- Completion
- 2025-01-01
- First posted
- 2023-12-20
- Last updated
- 2024-01-29
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06178003. Inclusion in this directory is not an endorsement.