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

Phase I Clinical Study on the Safety, Tolerability, and Pharmacokinetics of Recombinant Human nsIL12 Oncolytic Adenovirus Injection (BioTTT001) in Patients With Malignant Solid Tumors

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Solid Tumor
• Intervention / Treatment: Biological: BioTTT001 injection

Detailed Description

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 protect the safety of the subjects, during the DLT observation phase of the same dose group, the first subject in each dose group can only be enrolled in the second subject after at least 2 weeks after administration. The DLT observation period for each subject is 28 days after the first administration, and the last subject in each dose group can only enter the next dose escalation after completing the DLT observation period. At least 3 subjects are enrolled in each dose group, and each subject only receives one corresponding dose.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China
      • The First Affiliated Hospital of China Medical Univeristy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age range from 18 to 80 years old (including the threshold), no gender restrictions.
2. Patients with histologically and/or cytologically confirmed malignant solid tumors, who have experienced at least one-line standard treatment failure or intolerance, or lack standard treatment options. Focus on malignancies in the head and neck, colorectal cancer, skin malignancies, and cervical cancer.
3. At least one assessable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
4. Assessed by the investigators to have lesions suitable for intratumoral injection (assessable lesions and intratumoral injection lesions can refer to the same lesion).

Exclusion Criteria:

1. Known allergy to the investigational drug or its components.
2. Previous treatment with other adenovirus drugs.
3. Patients with active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, etc.), except type 1 diabetes, hypothyroidism that only needs hormone replacement therapy, and skin diseases that do not need systemic treatment (such as vitiligo, psoriasis or alopecia).
4. Patients who have not recovered from the adverse reactions of previous treatments (the treatment-related toxicity ≤ grade 2, except for alopecia, pigmentation or other tolerable events judged by the investigator ).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BioTTT001 injection; BioTTT001 is administered as a single Intratumoral injection. The dose groups to be infusion were 5×10^9 viral particle (VP) ,5×10^10 VP and 5×10^11 VP based on the 3+3 dose escalation principle.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	The incidence and severity of all types of adverse events evaluated based on NCI-CTCAE V5.0 assessment	28 days within BioTTT001 injection
MTD	Maximum tolerated dose (MTD)	28 days within BioTTT001 injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Adenovirus (ADV) copies	Pharmacokinetic Study (PK): Copies of ADV in plasma at various sampling points.	28 days within BioTTT001 injection
ADV copies in various sites	Viral Shedding Analysis: Copies of ADV in swabs of injection sites, rectal swabs, throat swabs, and urine samples at various sampling points.	28 days within BioTTT001 injection
Serum interleukin-12 (IL-12) level	Expression levels of IL-12 at various sampling points in serum.	28 days within BioTTT001 injection
Serum neutralizing antibody level	Immunogenicity assessment through neutralizing antibody detection.	28 days within BioTTT001 injection
ORR	Objective response rate (ORR) as assessed by the investigators.	From date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
DCR	Disease control rate (DCR) as assessed by the investigators.	From date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
PFS	Progression-free survival (PFS) as assessed by the investigators.	From date of the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

Collaborators and Investigators

• Sponsor: Beijing Bio-Targeting Therapeutics Technology Co., Ltd
• Investigators: Principal Investigator: Zhenning Wang, MD, The First Affiliated Hospital of China Medical Univeristy; Principal Investigator: Funan Liu, MD, The First Affiliated Hospital of China Medical Univeristy

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 28, 2026

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): November 26, 2025
• Last Update Submitted That Met QC Criteria: November 25, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Adenovirus; Oncolytic virus; IL-12
• Additional Relevant MeSH Terms: Infections; Virus Diseases; DNA Virus Infections; Adenoviridae Infections
• Other Study ID Numbers: BJCT-01-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No