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A Clinical Study to Explore the Safety, Tolerability, and Efficacy of Recombinant Human nsIL12 Oncolytic Adenovirus Injection (BioTTT001) Combined With Neoadjuvant Treatment for Locally Advanced Breast Cancer

NCT07150767 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2025-12-02

No results posted yet for this study

Summary

A clinical study to explore the safety, tolerability, and efficacy of recombinant human nsIL12 oncolytic adenovirus injection (BioTTT001) combined with neoadjuvant treatment for locally advanced breast cancer.This study is a single-arm, open-label, single-center dose-escalation and expansion trial.

Conditions

  • Locally Advanced Breast Cancer (LABC)

Interventions

BIOLOGICAL

BioTTT001 injection

BioTTT001 is administered as a multiple Intratumoral injection. The dose groups to be infusion were 5.0×10\^10 viral particle (VP) ,2.0×10\^11 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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-26
Primary Completion
2027-03-26
Completion
2027-03-26

Countries

  • China

Study Locations

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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 NCT07150767 on ClinicalTrials.gov