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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06215846
Other study ID # BJCT-01-101
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date January 22, 2024
Est. completion date April 2, 2026

Study information

Verified date January 2024
Source Beijing Bio-Targeting Therapeutics Technology Co., Ltd
Contact Shijie Duan, MD
Phone +8613898810226
Email duanshijiekk@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 12
Est. completion date April 2, 2026
Est. primary completion date April 2, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 1. Age range from 18 to 70 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China The First Affiliated Hospital of China Medical Univeristy Shenyang Liaoning

Sponsors (1)

Lead Sponsor Collaborator
Beijing Bio-Targeting Therapeutics Technology Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary MTD Maximum tolerated dose (MTD) 28 days within BioTTT001 injection
Secondary Plasma Adenovirus (ADV) copies Pharmacokinetic Study (PK): Copies of ADV in plasma at various sampling points. 28 days within BioTTT001 injection
Secondary 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
Secondary Serum interleukin-12 (IL-12) level Expression levels of IL-12 at various sampling points in serum. 28 days within BioTTT001 injection
Secondary Serum neutralizing antibody level Immunogenicity assessment through neutralizing antibody detection. 28 days within BioTTT001 injection
Secondary 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
Secondary 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
Secondary 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
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