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Trial Title:
A Clinical Study of BioTTT001 in Combination With SOX and Toripalimab in Patients With Gastric Cancer
NCT ID:
NCT06283121
Condition:
Gastric Cancer, Metastatic
Conditions: Official terms:
Stomach Neoplasms
Conditions: Keywords:
oncolytic virus
IL-12
gastric cancer
peritoneal metastases
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
BioTTT001 intraperitoneal infusion
Description:
Monotherapy lead-in phase: BioTTT01 1×10^10 VP, i.p., D1 and D3; Combination therapy
phase: BioTTT01 1×10^10 VP, i.p., D1 and D3, 3 weeks per cycle
Arm group label:
Combination therapy with BioTTT001 intraperitoneal infusion , SOX and Toripalimab
Intervention type:
Drug
Intervention name:
SOX regimen
Description:
Combination therapy phase: Oxaliplatin 130 mg，i.v., D1 and D3, 3 weeks per cycle; Tegafur
40~60mg b.i.d. p.o. D1~D14; 3 weeks per cycle
Arm group label:
Combination therapy with BioTTT001 intraperitoneal infusion , SOX and Toripalimab
Intervention type:
Drug
Intervention name:
toripalimab
Description:
Combination therapy phase: toripalimab 160mg i.v. D1, 3 weeks per cycle.
Arm group label:
Combination therapy with BioTTT001 intraperitoneal infusion , SOX and Toripalimab
Summary:
This is a phase I, single arm, open-label clinical study of BioTTT001 in combination with
SOX and Toraplizumab in patients with peritoneal metastases from gastric cancer.
Detailed description:
This study intends to enroll Her2-negative subjects with first-line treatment of
peritoneal metastasis from gastric cancer. Subjects will be treated with BioTTT001
intraperitoneal perfusion combined with SOX and toripalimab after completing the
screening period, and the subjects will first receive BioTTT001 monotherapy treatment
with BioTTT001 1×10^10 viral particle (VP) intraperitoneal perfusion (P.I.), D1 and D3,
and enter the combination therapy stage 7 days (±1d) after the first dose of
BioTTT001.Subjects will be treated with the regimen as follows: BioTTT001 injection,
1×10^10 VP P.I., D1；toripalimab 160mg intravenous (i.v.), D1; Oxaliplatin 130mg/m^2 i.v.
, D1 ; Tegafur 40~60mg Bis in die（b.i.d.） Peroral（p.o.）D1~D14; 3 weeks per cycle.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female, age≥ 18 years；
2. Patients with a diagnosis of gastric cancer by histopathology or cytology,
accompanied by peritoneal metastasis, without systemic therapy, or for patients who
have received neoadjuvant/adjuvant chemotherapy before, the time from last treatment
to disease recurrence > 6 months;
3. Tumor Her2 negative (IHC 0/1＋ or IHC 2＋ and FISH-).
4. At least one measurable lesion according to the Response Evaluation Criteria in
Solid Tumors （RECIST) 1.1;
5. WBC≥3.0×10^9 /L; ANC≥1.5×10^9 /L; HB≥90 g/L; PLT≥75×10^9 /L;
6. ALT and AST≤3×ULN (≤5×ULN with liver metastasis); ALB≥20g/L; Cr≤1.5×ULN or CCr>50
mL/min; TBIL≤1.5×ULN; APTT≤1.5×ULN and INR or PT≤1.5×ULN (without anticoagulation
therapy)
7. LVEF≥50%; male QTc≤450 mms, female QTc≤470 mms;
8. ECOG 0~1；
9. Expected survival ≥ 3 months;
10. Consent to contraception；
11. Understand and voluntarily sign a written ICF and be willing to comply with all
trial requirements.
Exclusion Criteria:
1. History of other malignancies (except cured basal cell skin cancer, cervical
carcinoma in situ etc.) within 5 years before study drug administration;
2. Patients with central nervous system metastases with clinical symptoms;
3. Patients who have been treated with high-dose systemic corticosteroids (prednisone >
10 mg/day or equivalent doses) or other immunosuppressants within 2 weeks before the
first dose of BioTTT001;
4. Previous treatment with other adenovirus drugs within 28 days before the first dose
of BioTTT001;
5. Patients who have undergone any major surgery (except needle biopsy, etc.) or severe
trauma within 14 days before the first dose of BioTTT001;
6. Patients who have not recovered from the adverse reactions of previous treatments
(the treatment-related toxicity ≤ grade 2, except for alopecia );
7. Patients with primary immunodeficiency;
8. 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);
9. Patients with active infection requiring systemic anti-infective therapy;
10. HBsAg positive, and blood HBV DNA≥100 IU/mL; anti-HCV positive; HIV positive; active
syphilis;
11. Patients with active tuberculosis or drug-induced interstitial lung disease；
12. Patients with active inflammatory bowel disease ；
13. NYHA≥ grade 3；
14. Known allergy to the investigational drug or its components;
15. Patients with prior organ transplants;
16. Pregnant or lactating women;
17. Other reasons judged by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
April 2, 2024
Completion date:
November 30, 2027
Lead sponsor:
Agency:
China Medical University, China
Agency class:
Other
Collaborator:
Agency:
Beijing Bio-Targeting Therapeutics Technology Co., Ltd
Agency class:
Industry
Source:
China Medical University, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06283121
