A Clinical Study Evaluating the Safety and Efficacy of BioTTT001 in Patients With Malignant Solid Tumors
Condition(s) studied
Investigational drug(s) / intervention(s)
BioTTT001 injection: BioTTT001 is administered as a single Intratumoral injection. The dose groups to be infusion were 5×10\^9 VP, 5×10\^10 VP and 5×10\^11 VP based on the 3+3 dose escalation principle.
Study summary
This is a Phase 1 open-label study to evaluate the safety, tolerability, and pharmacokinetics of Recombinant Human nsIL12 Oncolytic Adenovirus Injection (BioTTT001) at dose of 5×10∧9VP、5×10∧10VP、5×10∧11VP in Patients With Malignant Solid Tumors. Subjects will be treated with a single dose of BioTTT001 Injection after the screening period.
Eligibility
Primary outcome measure(s)
- Incidence of adverse events — 28 days within BioTTT001 injection
The incidence and severity of all types of adverse events evaluated based on NCI-CTCAE V5.0 assessment - MTD — 28 days within BioTTT001 injection
Maximum tolerated dose (MTD)
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| The First Affiliated Hospital of China Medical Univeristy | Shenyang | Liaoning |
More Beijing Bio-Targeting Therapeutics Technology Co., Ltd trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06215846 on ClinicalTrials.gov ↗ ← All trials in China