Gastric Cancer, MetastaticPhase 2NCT06283121
A Clinical Study of BioTTT001 in Combination With SOX and Toripalimab in Patients With Gastric Cancer
A Phase 2 study testing BioTTT001 intraperitoneal infusion, SOX regimen and toripalimab in people with Gastric Cancer, Metastatic, run by China Medical University, China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Metastatic
- What is being tested?
- BioTTT001 intraperitoneal infusion, SOX regimen and toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 2 Apr 2024to 30 Nov 2027
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age≥ 18 years；
- 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;
- Tumor Her2 negative (IHC 0/1＋ or IHC 2＋ and FISH-).
- 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; HB≥90 g/L; PLT≥75×10^9 /L;
- 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)
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- LVEF≥50%; male QTc≤450 mms, female QTc≤470 mms;
- ECOG 0~1；
- Expected survival ≥ 3 months;
- Consent to contraception；
- Understand and voluntarily sign a written ICF and be willing to comply with all trial requirements.
Who cannot join
- History of other malignancies (except cured basal cell skin cancer, cervical carcinoma in situ etc.) within 5 years before study drug administration;
- Patients with central nervous system metastases with clinical symptoms;
- 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;
- Previous treatment with other adenovirus drugs within 28 days before the first dose of BioTTT001;
- Patients who have undergone any major surgery (except needle biopsy, etc.) or severe trauma within 14 days before the first dose of BioTTT001;
- Patients who have not recovered from the adverse reactions of previous treatments (the treatment-related toxicity ≤ grade 2, except for alopecia );
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- Patients with primary immunodeficiency;
- 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 with active infection requiring systemic anti-infective therapy;
- HBsAg positive, and blood HBV DNA≥100 IU/mL; anti-HCV positive; HIV positive; active syphilis;
- Patients with active tuberculosis or drug-induced interstitial lung disease；
- Patients with active inflammatory bowel disease ；
- NYHA≥ grade 3；
- Known allergy to the investigational drug or its components;
- Patients with prior organ transplants;
- Pregnant or lactating women;
- Other reasons judged by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Clinical Study to Evaluate the Safety and Efficacy of Recombinant Human nsIL12 Oncolytic Adenovirus Injection (BioTTT001) in Combination With SOX and Toripalimab in Patients With Peritoneal Metastases From Gastric Cancer
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.
Read the 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.
- Conditions
- Gastric Cancer, Metastatic
- Being tested
- BioTTT001 intraperitoneal infusion, SOX regimen, toripalimab
- Keywords
- oncolytic virus, IL-12, gastric cancer, peritoneal metastases
- Medical subject headings
- Stomach Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioTTT001 intraperitoneal infusionBiological
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
SOX regimenDrug
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
toripalimabDrug
Combination therapy phase: toripalimab 160mg i.v. D1, 3 weeks per cycle.
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy with BioTTT001 intraperitoneal infusion , SOX and Toripalimab | Experimental | 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 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. Receives: Biological: BioTTT001 intraperitoneal infusion; Drug: SOX regimen; Drug: toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Objective response rate (ORR) as assessed by the investigators
Measured: Imaging was performed every 6 weeks during the combination therapy phase
Secondary outcomes (2)
Progression-free survival (PFS)
The time from the start of treatment to progress disease or death for any cause
Measured: Every 6 weeks until disease progression, consent withdraw, death or end of study during the combination therapy phase, up to 100 weeks.
Overall survival (OS)
The time from the start of treatment to death for any cause
Measured: Every 3 months until consent withdraw, death, withdrawal study, or loss of follow-up, up to 100 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start2 Apr 2024 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer, MetastaticStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Bio-Targeting Therapeutics Technology Co., Ltd
- Responsible party
- Principal investigator, Funan Liu, China Medical University, China
- 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
- NCT06283121
- Sponsor's protocol ID
- BJCT-CMU1H-01
- Status last verified
- Feb 2024
- First submitted
- 22 Feb 2024
- Last updated
- 29 Feb 2024
- 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 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety and Efficacy of Recombinant Human nsIL12 Oncolytic Adenovirus Injection (BioTTT001) in Combination With SOX and Toripalimab in Patients With Peritoneal Metastases From Gastric Cancer
- ClinicalTrials.gov ID
- NCT06283121
- Acronym / sponsor ID
- BJCT-CMU1H-01
- Conditions
- Gastric Cancer, Metastatic
- Keywords
- oncolytic virus, IL-12, gastric cancer, peritoneal metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Collaborators
- Beijing Bio-Targeting Therapeutics Technology Co., Ltd
- Study start
- 2 Apr 2024 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 28 Feb 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination therapy with BioTTT001 intraperitoneal infusion , SOX and Toripalimab | Experimental | Biological: BioTTT001 intraperitoneal infusion, Drug: SOX regimen, Drug: toripalimabThis 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 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female, age≥ 18 years；
- 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;
- Tumor Her2 negative (IHC 0/1＋ or IHC 2＋ and FISH-).
- 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; HB≥90 g/L; PLT≥75×10^9 /L;
Key exclusion criteria (17 listed)
- History of other malignancies (except cured basal cell skin cancer, cervical carcinoma in situ etc.) within 5 years before study drug administration;
- Patients with central nervous system metastases with clinical symptoms;
- 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;
- Previous treatment with other adenovirus drugs within 28 days before the first dose of BioTTT001;
- Patients who have undergone any major surgery (except needle biopsy, etc.) or severe trauma within 14 days before the first dose of BioTTT001;
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 intraperitoneal infusionMonotherapy 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 | Biological | Combination therapy with BioTTT001 intraperitoneal infusion , SOX and Toripalimab |
| SOX regimenCombination 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 | Drug | Combination therapy with BioTTT001 intraperitoneal infusion , SOX and Toripalimab |
| toripalimabCombination therapy phase: toripalimab 160mg i.v. D1, 3 weeks per cycle. | Drug | Combination therapy with BioTTT001 intraperitoneal infusion , SOX and Toripalimab |
Primary outcome
Objective response rate (ORR)
Time frame: Imaging was performed every 6 weeks during the combination therapy phase
Objective response rate (ORR) as assessed by the investigators
2 secondary outcomes
Progression-free survival (PFS)
Time frame: Every 6 weeks until disease progression, consent withdraw, death or end of study during the combination therapy phase, up to 100 weeks.
Overall survival (OS)
Time frame: Every 3 months until consent withdraw, death, withdrawal study, or loss of follow-up, up to 100 weeks
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 29 Feb 2024.
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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.
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
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BioTTT001 intraperitoneal infusion, SOX regimen and toripalimab in people with Gastric Cancer, Metastatic, run by China Medical University, 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 11 inclusion and 17 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: opening soon, as of the sponsor's last update on 29 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Shuhui Song, bachelor (15004240769 ext. 024, 593900927@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Imaging was performed every 6 weeks during the combination therapy phase). 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 29 Feb 2024.