Status:
ENROLLING_BY_INVITATION
A Clinical Study Evaluating the Safety and Efficacy of BioTTT001 in Patients With Malignant Solid Tumors
Lead Sponsor:
Beijing Bio-Targeting Therapeutics Technology Co., Ltd
Conditions:
Solid Tumor
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
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∧...
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 ...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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 ).
Key Trial Info
Start Date :
May 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 28 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06215846
Start Date
May 7 2024
End Date
June 28 2026
Last Update
November 26 2025
Active Locations (1)
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1
The First Affiliated Hospital of China Medical Univeristy
Shenyang, Liaoning, China