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Clinical Trials in China / NCT06215846
Enrolling by invitation Phase 1

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

NCT06215846 · tracked via the Priya Life Science China tracker
Sponsor
Beijing Bio-Targeting Therapeutics Technology Co., Ltd
Phase
Phase 1
Started
2024-05-07
Last updated
2025-11-26

Condition(s) studied

Solid Tumor

Investigational drug(s) / intervention(s)

BioTTT001 injection

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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 ).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of China Medical Univeristy Shenyang Liaoning

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06215846 on ClinicalTrials.gov ↗ ← All trials in China