A Clinical Study to Explore the Safety, Tolerability, and Efficacy of Recombinant Human nsIL12 On… (NCT07150767) | Clinical Trial Compass
WithdrawnPhase 1
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
Stopped: The applicant voluntarily withdrew the case
China0Started 2025-03-26
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. 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:
✓. 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.;
Exclusion criteria
✕. 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);
What they're measuring
1
Incidence of adverse events
Timeframe: The DLT observation period for each subject is 21 days after the first dose
✕. 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;
✕. 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;