Solid TumorPhase 1NCT06215846
A Clinical Study Evaluating the Safety and Efficacy of BioTTT001 in Patients With Malignant Solid Tumors
A Phase 1 study testing BioTTT001 injection in people with Solid Tumor, run by Beijing Bio-Targeting Therapeutics Technology Co., Ltd at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- BioTTT001 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 7 May 2024to 28 Jun 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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 ).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of China Medical Univeristy
Shenyang, Liaoning
About this study
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
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.
Read the 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 escalation from low to high, the "3+3" dose escalation method is adopted. In theory, in order to protect the safety of the subjects, during the DLT observation phase of the same dose group, the first subject in each dose group can only be enrolled in the second subject after at least 2 weeks after administration. The DLT observation period for each subject is 28 days after the first administration, and the last subject in each dose group can only enter the next dose escalation after completing the DLT observation period. At least 3 subjects are enrolled in each dose group, and each subject only receives one corresponding dose.
- Conditions
- Solid Tumor
- Being tested
- BioTTT001 injection
- Keywords
- Oncolytic virus, IL-12, Adenovirus
- Medical subject headings
- Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioTTT001 injectionBiological
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 group | Role | What they receive |
|---|---|---|
| BioTTT001 injection | Experimental | 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. Receives: Biological: BioTTT001 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
The incidence and severity of all types of adverse events evaluated based on NCI-CTCAE V5.0 assessment
Measured: 28 days within BioTTT001 injection
MTD
Maximum tolerated dose (MTD)
Measured: 28 days within BioTTT001 injection
Secondary outcomes (7)
Plasma Adenovirus (ADV) copies
Pharmacokinetic Study (PK): Copies of ADV in plasma at various sampling points.
Measured: 28 days within BioTTT001 injection
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.
Measured: 28 days within BioTTT001 injection
Serum interleukin-12 (IL-12) level
Expression levels of IL-12 at various sampling points in serum.
Measured: 28 days within BioTTT001 injection
Serum neutralizing antibody level
Immunogenicity assessment through neutralizing antibody detection.
Measured: 28 days within BioTTT001 injection
ORR
Objective response rate (ORR) as assessed by the investigators.
Measured: 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
DCR
Disease control rate (DCR) as assessed by the investigators.
Measured: 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
PFS
Progression-free survival (PFS) as assessed by the investigators.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start7 May 2024
- Primary completion30 May 2026 (estimated)
- Study completion28 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Bio-Targeting Therapeutics Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhenning Wang, MD, Principal investigator, The First Affiliated Hospital of China Medical UniveristyFunan Liu, MD, Principal investigator, The First Affiliated Hospital of China Medical Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215846
- Sponsor's protocol ID
- BJCT-01-101
- Status last verified
- Sep 2025
- First submitted
- 27 Nov 2023
- Last updated
- 26 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06215846
- Acronym / sponsor ID
- BJCT-01-101
- Conditions
- Solid Tumor
- Keywords
- Oncolytic virus, IL-12, Adenovirus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Beijing Bio-Targeting Therapeutics Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 7 May 2024 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 28 Jun 2026 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 escalation from low to high, the "3+3" dose escalation method is adopted. In theory, in order to protect the safety of the subjects, during the DLT observation phase of the same dose group, the first subject in each dose group can only be enrolled in the second subject after at least 2 weeks after administration. The DLT observation period for each subject is 28 days after the first administration, and the last subject in each dose group can only enter the next dose escalation after completing the DLT observation period. At least 3 subjects are enrolled in each dose group, and each subject only receives one corresponding dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BioTTT001 injection | Experimental | Biological: BioTTT001 injectionBioTTT001 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- 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 ).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioTTT001 injectionBioTTT001 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. | Biological | BioTTT001 injection |
Primary outcome
Incidence of adverse events
Time frame: 28 days within BioTTT001 injection
The incidence and severity of all types of adverse events evaluated based on NCI-CTCAE V5.0 assessment
MTD
Time frame: 28 days within BioTTT001 injection
Maximum tolerated dose (MTD)
7 secondary outcomes
Plasma Adenovirus (ADV) copies
Time frame: 28 days within BioTTT001 injection
ADV copies in various sites
Time frame: 28 days within BioTTT001 injection
Serum interleukin-12 (IL-12) level
Time frame: 28 days within BioTTT001 injection
Serum neutralizing antibody level
Time frame: 28 days within BioTTT001 injection
ORR
Time frame: 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
DCR
Time frame: 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
PFS
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
Related trials for Solid Tumor
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhenning Wang, MD principal investigator
The First Affiliated Hospital of China Medical Univeristy
Funan Liu, MD principal investigator
The First Affiliated Hospital of China Medical Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BioTTT001 injection in people with Solid Tumor, run by Beijing Bio-Targeting Therapeutics Technology Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: 28 days within BioTTT001 injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.