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A Clinical Study Evaluating the Safety and Efficacy of BioTTT001 in Patients With Malignant Solid Tumors

NCT06215846 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-11-26

No results posted yet for this 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.

Conditions

Interventions

BIOLOGICAL

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.

Sponsors & Collaborators

  • Beijing Bio-Targeting Therapeutics Technology Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Zhenning Wang, MD · The First Affiliated Hospital of China Medical Univeristy

  • Funan Liu, MD · The First Affiliated Hospital of China Medical Univeristy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-07
Primary Completion
2026-05-30
Completion
2026-06-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06215846 on ClinicalTrials.gov