Locally Advanced Breast Cancer (LABC)Phase 1NCT07150767
A Clinical Study to Explore the Safety, Tolerability, and Efficacy of Recombinant Human nsIL12 Oncolytic Adenovirus Injection (BioTTT001) Combined With Neoadjuvant Treatment for Locally Advanced Breast Cancer
A Phase 1 study testing BioTTT001 injection in people with Locally Advanced Breast Cancer (LABC), run by Beijing Bio-Targeting Therapeutics Technology Co., Ltd at 1 site in China.
Trial summary
A clinical study to explore the safety, tolerability, and efficacy of recombinant human nsIL12 oncolytic adenovirus injection (BioTTT001) combined with neoadjuvant treatment for locally advanced breast cancer.This study is a single-arm, open-label, single-center dose-escalation and expansion trial. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Locally Advanced Breast Cancer (LABC)
- 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
- 0 participants
- Where
- 1 siteChina
- Study dates
- 26 Mar 2025to 26 Mar 2027
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age> 18 years old (including cut-off value), female;
- Patients with resectable stage II.a-III.c primary non-metastatic breast cancer confirmed by histopathology and/or cytology (clinical stage: cT2-T4, cN0-N3, M0);
- At least one evaluable lesion according to RECIST 1.1 in solid tumors
- There are lesions suitable for intratumoral injection as assessed by the investigator (the evaluable lesion and the intratumoral injection lesion can be the same lesion);
- ECOG PS score 0-1 points;
- The values of the laboratory tests performed for screening must meet the following standards:
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- Routine blood tests:
- WBC≥3.0×10^9/L； ANC ≥ 1.5×10^9/L, and no cytokine correction therapy within 1 week prior to screening; Subjects with Hb≥90g/L and no blood transfusion within 1 week; Subjects who have a white > of 80g/L before blood transfusion and have received blood transfusion within 3 days before screening to meet the standard (Hb≥90g/L); PLT≥90×10^9/L and no platelet transfusion or thrombopoietin corrective therapy within 1 week prior to screening.
- Blood biochemical tests:
- ALT and AST≤ 3×ULN (or ≤5×ULN if with liver metastases); Serum creatinine ≤1.5×ULN or CCr>50mL/min; TBIL≤1.5×ULN； APTT≤1.5×ULN, while INR or PT≤1.5×ULN;
- Expected survival ≥ 3 months;
- All subjects and their partners have no birth plan from screening to the end of the trial and agree to take effective non-drug contraceptive measures (such as condoms, intrauterine devices without medication, etc.) during the trial, except for those who have taken permanent contraceptive measures, such as bilateral tubal ligation, vasectomy, etc.;
- Volunteer to participate in clinical research and sign the informed consent form.
Who cannot join
- Known allergy to the study drug or its components;
- Those who have received other adenovirus drugs;
- Patients with active or previously suffered autoimmune diseases that may recur (such as systemic lupus erythematosus, rheumatoid arthritis, etc.), except for type 1 diabetes, hypothyroidism that only needs to be treated with hormone replacement, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or alopecia);
- Treatment with nitrosoureas or mitomycin C within 6 weeks prior to starting study treatment; Received oral fluorouracil and small molecule targeted drug therapy within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to starting study treatment; Received traditional Chinese medicine treatment with anti-tumor indications within 2 weeks before starting study treatment; Received anti-tumor therapy such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, etc. other than the above-mentioned drugs within 28 days before starting study treatment, or received any other unmarketed investigational drugs;
- Those who have not recovered from the adverse reactions of previous treatment (treatment-related toxicity grade ≤ grade 2, except for alopecia, pigmentation and other tolerable events as judged by the investigator or laboratory abnormalities allowed according to the protocol);
- Other malignant tumors occurred within 5 years before enrollment, except for carcinoma in situ of the cervix that has been effectively resected and does not require continued anti-tumor treatment, low-risk to very low-risk gastrointestinal stromal tumors (primary tumors at any site, tumor size is ≤5cm, and the number of nuclear division images per 50 high-power field ≤5), in situ or early (stage I) breast cancer, basal cell carcinoma of the skin, papillary thyroid carcinoma;
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- Those who have undergone any major surgery (except for needle biopsy, etc.) or severe trauma within 4 weeks before the first dose;
- Patients who have been treated with high-dose systemic corticosteroids (prednisone> 10mg/day or equivalent dose of similar drugs) or other immunosuppressants within 2 weeks before the first dose. In addition to the following conditions: treatment with topical, ocular, intraarticular, intranasal and inhaled corticosteroids; short-term use of corticosteroids for prophylactic treatment, such as the use of contrast agents;
- Congestive heart failure with cardiac function ≥ NYHA class III; Acute myocardial infarction or unstable angina within 6 months prior to dosing; Left ventricular ejection fraction (LVEF) <50%; Corrected QTc interval (corrected by Fridericia's formula) > 450 msec for males and >470 msec for females, or risk factors for torsades de pointes, such as clinically significant hypokalemia, family history of long QT syndrome, or familial history of cardiac arrhythmias (eg, preexcitation syndrome) as judged by the investigator;
- Active tuberculosis, drug-induced interstitial lung disease;
- Presence of active inflammatory bowel disease (such as Crohn's disease or ulcerative colitis);
- Active infection requiring systemic anti-infective therapy; Unexplained fever > 38.5°C (neoplastic fever subjects are judged by the investigator to be included in the study);
- Immunosuppressed, such as severe combined immunodeficiency disease or concurrent opportunistic infections;
- Active hepatitis B (positive for HBsAg and 100IU/mL for HBV DNA titer test ≥100IU/mL) and/or positive for anti-HCV (and positive for HCV RNA) at screening; Patients with active syphilis infection or positive human immunodeficiency virus (HIV) screening results;
- Pleural effusion and ascites with clinical symptoms that require repeated drainage;
- Central nervous system metastases or meningeal metastases with clinical symptoms, or other evidence of central nervous system metastases or meningeal metastases with clinical symptoms, or other evidence that the patient's central nervous system metastases or meningeal metastases have not been controlled, and are judged by the investigator to be unsuitable for enrollment;
- Pregnant or lactating women;
- Patients with previous organ transplantation;
- The investigator believes that the patient is not suitable for this trial for any reason.
Trial locations and contacts
1 site in 1 country.
China1 site
The Second People's Hospital of Shandong Province
Jinan, Shandong, 250022
About this study
A clinical study to explore the safety, tolerability, and efficacy of recombinant human nsIL12 oncolytic adenovirus injection (BioTTT001) combined with neoadjuvant treatment for locally advanced breast cancer.This study is a single-arm, open-label, single-center dose-escalation and expansion trial.
Read the detailed description
Three study drug dose groups were preset, namely 5×10^10VP、2×10^11VP and 5×10^11VP and the "3+ 3" dose escalation method was adopted according to the principle of dose escalation and the sequential principle from low to high.In order to protect the safety of subjects, in theory, in order to protect the safety of subjects, the second subject can be enrolled at least 2 weeks after the administration of the first subject in each dose group at least 2 weeks after administration in the DLT observation phase of the same dose group. The DLT observation period for each subject is 21 days after the first dose, and the next dose escalation can only be entered after the last subject in each dose group completes the DLT observation period. At least 3 subjects were enrolled in each dose group, and each subject received only one corresponding dose.
- Conditions
- Locally Advanced Breast Cancer (LABC)
- Being tested
- BioTTT001 injection
- Keywords
- Recombinant Human nsIL12 Oncolytic Adenovirus Injection (BioTTT001)
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 multiple Intratumoral injection. The dose groups to be infusion were 5.0×10^10 viral particle (VP) ,2.0×10^11 VP and 5×10^11 VP based on the 3+3 dose escalation principle.
| Study group | Role | What they receive |
|---|---|---|
| BioTTT001 is administered as a single Intratumoral injection. | Experimental | HER-2 positive breast cancer group、triple-negative breast cancer group、Hormone receptor-positive breast cancer group: BioTTT001: According to the dose escalation requirements, a total of three injections of BioTTT001 d1, d3, and d5 in the first cycle, and the sequential neoadjuvant regimen was started on d22 days. Subsequently, according to the administration time of the neoadjuvant regimen, one dose of the same dose of BioTTT001 was supplemented every cycle d15.HER-2 positive breast cancer group：THP regimen: albumin paclitaxel 125 mg/m2, d1, d8;Trastuzumab 8mg/kg for the first dose, then 6 mg/kg, d1;Pertuzumab is 840mg for the first dose, followed by 420mg, d1, Q3w.4 cycles in total.triple-negative breast cancer group：albumin paclitaxel 125 mg/m2,d1,d8;Carboplatin AUC=5 d1;Toripalimab 240mg, d1, Q3w, a total of 4 cycles.Hormone receptor-positive breast cancer group:
Docetaxel 75mg/m2, d1;Doxorubicin 50mg/m2,d1;Cyclophosphamide 500mg/m2, d1, Q3w, a total of 6 cycles. 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
Incidence and severity of dose-limiting toxicities (DLTs) and various adverse events assessed based on NCI-CTCAE V5.0.Maximum tolerated dose (MTD) and recommended dose (RP2D).
Measured: The DLT observation period for each subject is 21 days after the first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study start26 Mar 2025
- Primary completion26 Mar 2027 (estimated)
- Study completion26 Mar 2027 (estimated)
Why it stopped: The applicant voluntarily withdrew the case
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Breast Cancer (LABC)Studies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Bio-Targeting Therapeutics Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150767
- Sponsor's protocol ID
- IIT-01-108
- Status last verified
- Nov 2025
- First submitted
- 25 Aug 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Explore the Safety, Tolerability, and Efficacy of Recombinant Human nsIL12 Oncolytic Adenovirus Injection (BioTTT001) Combined With Neoadjuvant Treatment for Locally Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT07150767
- Acronym / sponsor ID
- IIT-01-108
- Conditions
- Locally Advanced Breast Cancer (LABC)
- Keywords
- Recombinant Human nsIL12 Oncolytic Adenovirus Injection (BioTTT001)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The applicant voluntarily withdrew the case
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beijing Bio-Targeting Therapeutics Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 26 Mar 2027 (estimated)
- Study completion
- 26 Mar 2027 (estimated)
- First posted
- 2 Sep 2025 (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.
A clinical study to explore the safety, tolerability, and efficacy of recombinant human nsIL12 oncolytic adenovirus injection (BioTTT001) combined with neoadjuvant treatment for locally advanced breast cancer.This study is a single-arm, open-label, single-center dose-escalation and expansion trial.
Detailed description
Three study drug dose groups were preset, namely 5×10^10VP、2×10^11VP and 5×10^11VP and the "3+ 3" dose escalation method was adopted according to the principle of dose escalation and the sequential principle from low to high.In order to protect the safety of subjects, in theory, in order to protect the safety of subjects, the second subject can be enrolled at least 2 weeks after the administration of the first subject in each dose group at least 2 weeks after administration in the DLT observation phase of the same dose group. The DLT observation period for each subject is 21 days after the first dose, and the next dose escalation can only be entered after the last subject in each dose group completes the DLT observation period. At least 3 subjects were enrolled in each dose group, and each subject received only 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 is administered as a single Intratumoral injection. | Experimental | Biological: BioTTT001 injectionHER-2 positive breast cancer group、triple-negative breast cancer group、Hormone receptor-positive breast cancer group: BioTTT001: According to the dose escalation requirements, a total of three injections of BioTTT001 d1, d3, and d5 in the first cycle, and the sequential neoadjuvant regimen was started on d22 days. Subsequently, according to the administration time of the neoadjuvant regimen, one dose of the same dose of BioTTT001 was supplemented every cycle d15.HER-2 positive breast cancer group：THP regimen: albumin paclitaxel 125 mg/m2, d1, d8;Trastuzumab 8mg/kg for the first dose, then 6 mg/kg, d1;Pertuzumab is 840mg for the first dose, followed by 420mg, d1, Q3w.4 cycles in total.triple-negative breast cancer group：albumin paclitaxel 125 mg/m2,d1,d8;Carboplatin AUC=5 d1;Toripalimab 240mg, d1, Q3w, a total of 4 cycles.Hormone receptor-positive breast cancer group: Docetaxel 75mg/m2, d1;Doxorubicin 50mg/m2,d1;Cyclophosphamide 500mg/m2, d1, Q3w, a total of 6 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age> 18 years old (including cut-off value), female;
- Patients with resectable stage II.a-III.c primary non-metastatic breast cancer confirmed by histopathology and/or cytology (clinical stage: cT2-T4, cN0-N3, M0);
- At least one evaluable lesion according to RECIST 1.1 in solid tumors
- There are lesions suitable for intratumoral injection as assessed by the investigator (the evaluable lesion and the intratumoral injection lesion can be the same lesion);
- ECOG PS score 0-1 points;
Key exclusion criteria (19 listed)
- Known allergy to the study drug or its components;
- Those who have received other adenovirus drugs;
- Patients with active or previously suffered autoimmune diseases that may recur (such as systemic lupus erythematosus, rheumatoid arthritis, etc.), except for type 1 diabetes, hypothyroidism that only needs to be treated with hormone replacement, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or alopecia);
- Treatment with nitrosoureas or mitomycin C within 6 weeks prior to starting study treatment; Received oral fluorouracil and small molecule targeted drug therapy within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to starting study treatment; Received traditional Chinese medicine treatment with anti-tumor indications within 2 weeks before starting study treatment; Received anti-tumor therapy such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, etc. other than the above-mentioned drugs within 28 days before starting study treatment, or received any other unmarketed investigational drugs;
- Those who have not recovered from the adverse reactions of previous treatment (treatment-related toxicity grade ≤ grade 2, except for alopecia, pigmentation and other tolerable events as judged by the investigator or laboratory abnormalities allowed according to the protocol);
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 multiple Intratumoral injection. The dose groups to be infusion were 5.0×10^10 viral particle (VP) ,2.0×10^11 VP and 5×10^11 VP based on the 3+3 dose escalation principle. | Biological | BioTTT001 is administered as a single Intratumoral injection. |
Primary outcome
Incidence of adverse events
Time frame: The DLT observation period for each subject is 21 days after the first dose
Incidence and severity of dose-limiting toxicities (DLTs) and various adverse events assessed based on NCI-CTCAE V5.0.Maximum tolerated dose (MTD) and recommended dose (RP2D).
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Locally Advanced Breast Cancer (LABC), 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 13 inclusion and 19 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: withdrawn, as of the sponsor's last update on 2 Dec 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?
The study was withdrawn before enrolling participants, so there are no results.
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: The DLT observation period for each subject is 21 days after the first dose). 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 2 Dec 2025; AzTrials last refreshed its copy on 31 Oct 2026.