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

NCT06215846 | Enrolling By Invitation Phase 1

• 1 other identifier: BJCT-01-101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Solid Tumor

Keywords

Oncolytic virus; IL-12; Adenovirus

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Plasma Adenovirus (ADV) copies

  28 days within BioTTT001 injection

• ADV copies in various sites

  28 days within BioTTT001 injection

• Serum interleukin-12 (IL-12) level

  28 days within BioTTT001 injection

• Serum neutralizing antibody level

  28 days within BioTTT001 injection

• ORR

  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

Study Arms (1)

BioTTT001 injection

EXPERIMENTAL

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

Interventions

BioTTT001 injection BIOLOGICAL

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.

BioTTT001 injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range from 18 to 80 years old (including the threshold), no gender restrictions.
• 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.
• At least one assessable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
• Assessed by the investigators to have lesions suitable for intratumoral injection (assessable lesions and intratumoral injection lesions can refer to the same lesion).

You may not qualify if:

• Known allergy to the investigational drug or its components.
• Previous treatment with other adenovirus drugs.
• 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).
• 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 ).

Sponsors & Collaborators

• Beijing Bio-Targeting Therapeutics Technology Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital of China Medical Univeristy

Shenyang, Liaoning, China

Location

MeSH Terms

Conditions

Adenoviridae Infections

Condition Hierarchy (Ancestors)

DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Zhenning Wang, MD

  The First Affiliated Hospital of China Medical Univeristy

  PRINCIPAL INVESTIGATOR

• Funan Liu, MD

  The First Affiliated Hospital of China Medical Univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: January 22, 2024
• Study Start: May 7, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 28, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-09

Locations

CN (1)