Clinical trial · Interventional
A Clinical Study Evaluating the Safety and Efficacy of BioTTT001 in Patients With Malignant Solid Tumors
Phase I Clinical Study on the Safety, Tolerability, and Pharmacokinetics of Recombinant Human nsIL12 Oncolytic Adenovirus Injection (BioTTT001) in Patients With Malignant Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BioTTT001 injection | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BioTTT001 injection
- description
- 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.
- interventionNames
- Biological: BioTTT001 injection
Primary outcomes (2)
- measure
- Incidence of adverse events
- timeFrame
- 28 days within BioTTT001 injection
- description
- The incidence and severity of all types of adverse events evaluated based on NCI-CTCAE V5.0 assessment
- measure
- MTD
- timeFrame
- 28 days within BioTTT001 injection
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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 ).
References
Publications (0)
Data not yet available