This is a phase I, open-label clinical study of BioTTT001 in combination with Toraplizumab and Regorafenib in patients with liver metastases from colorectal cancer.
Age range from 18 to 70 years old (including the threshold), no gender restrictions;
Patients with a definitive histopathological or cytological diagnosis of colorectal cancer with hepatic metastases who have received and failed at least second-line standard therapy in the past, or who have been assessed by the investigator to be unsuitable for standard therapy;
At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1;
WBC≥3.0×10^9/L; ANC≥1.5×10^9/L (without cytokine therapy within one week before the screening ); Hb≥90g/L(without blood transfusion within one week before the screening);PLT≥90×10^9/L(without Platelet transfusion or thrombopoietin (TPO) within one week before the screening)；ALT and AST≤5×ULN；Cr≤1.5×ULN or CCr>50mL/min; TBIL≤1.5×ULN; APTT≤1.5×ULN and INR/PT≤1.5×ULN；
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);
Received treatment with nitrosourea or mitomycin C within 6 weeks before the first dose of BioTTT001; received oral fluorouracil and small molecule targeted drug therapy within 2 weeks or 5 half-lives of the drug within 2 weeks before the first dose of BioTTT001; received traditional Chinese medicine therapy with anti-tumor indications within 2 weeks before the first dose of BioTTT001; received chemotherapy, radiotherapy, biological therapy other than the drugs mentioned above within 28 days before the first dose of BioTTT001；
Single group
BioTTT001 hepatic artery infusion
Biological/VaccineBioTTT001 monotherapy period: BioTTT001 5×10\^9 VP/5×10\^10VP/1×10\^11 VP hepatic artery infusion, administered on D1 and D8, for a total of two doses after enrollment. BioTTT001 in combination with toripalimab and regorafenib period: BioTTT001 5×10\^9 VP/5×10\^10VP/1×10\^11 VP hepatic artery infusion, D2 and D16, 4 weeks per cycle.
toripalimab
DrugBioTTT001 in combination with toripalimab and regorafenib period: toripalimab 160mg intravenous D1 and D15, 4 weeks per cycle.
regorafenib
DrugBioTTT001 in combination with toripalimab and regorafenib period: regorafenib 80 mg oral administration, D1-D21, 4 weeks per cycle.
Incidence of adverse events
The incidence and severity of all types of adverse events evaluated based on NCI-CTCAE V5.0 assessment.
MTD
Maximum tolerated dose (MTD)
Overall survival(OS)
The time from the start of treatment to death for any cause
Progression-free survival (PFS)
The time from the start of treatment to progress disease or death for any cause
Objective response rate (ORR)
Objective response rate (ORR) as assessed by the investigators
Plasma adenovirus (ADV) copies
Pharmacokinetic Study (PK): Copies of ADV in plasma at various sampling points.
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China Medical University, China
Lead sponsor
Beijing Bio-Targeting Therapeutics Technology Co., Ltd
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
