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

StatusEnrolling by Invitation
PhasePhase 1
Started2024-05-07
View on ClinicalTrials.gov ↗
Record status
This record was last updated November 26, 2025 (before its estimated May 30, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2025-11-25
Study Status v3
Primary completion date2025-09-30→2026-05-30
Completion date2026-01-28→2026-06-28
2025-09-17
Study Identification, Study Status, Oversight, IPDSharing v2
Primary completion date2026-04-02→2025-09-30
Completion date2026-04-02→2026-01-28
Study titlerevised
A Clinical Study Evaluating the Safety and Efficacy of BioTTT001 in Patients withWith Malignant Solid Tumors
2025-01-02
Not Yet Recruiting→Enrolling by Invitation Study Identification, Study Status, Oversight, Study Description, Eligibility, Contacts/Locations, IPDSharing v1
Trial statusNot Yet Recruiting→Enrolling by Invitation
Start dateestimated 2024-01-22→confirmed 2024-05-07
Eligibility criteriarevised
Inclusion Criteria: Age range from 18 to 7080 years old (including the threshold), no gender restrictions [...]
Study description+834 characters
This study is a single arm, open label, single center dose escalation trial. Three study drug dosage groups are pre-set, namely 5 × 10∧9VP、5 × 10∧10VP、 5 × 10∧11VP. According to the principle of dose escalation from low to high, the "3+3" dose escalation method is adopted. In theory, in order to pro [...]
Study sitescontacts updated at 1 of 1 site
Study titlerevised
A Clinical Study Evaluating the Safety and Efficacy of BioTTT001 in Patients Withwith Malignant Solid Tumors
2024-01-18
Original filing
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.
Trial Details
NCT Number NCT06215846
Lead Sponsor Beijing Bio-Targeting Therapeutics Technology Co., Ltd
Conditions Solid Tumor
Enrollment 12 participants
Start Date 2024-05-07
Primary Completion 2026-05-30 (estimated)
Study Completion 2026-06-28 (estimated)
Updated on ClinicalTrials.gov 2025-11-26