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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06215846
• Other study ID #: BJCT-01-101
• Status: Not yet recruiting
• Phase: Phase 1
• 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
• 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 ).

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

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