Colorectal Cancer MetastaticPhase 1NCT06283134
A Clinical Study of BioTTT001 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer
A Phase 1 study testing BioTTT001 hepatic artery infusion, toripalimab and regorafenib in people with Colorectal Cancer Metastatic, run by China Medical University, China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- BioTTT001 hepatic artery infusion, toripalimab and regorafenib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to 1 Dec 2028
- Phase
- Phase 1
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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；
- ECOG 0~2；
- 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
- 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；
- Patients who have not recovered from the adverse reactions of previous treatments (the treatment-related toxicity ≤ grade 2, except for alopecia, pigmentation or other tolerable events judged by the investigator ).
- History of other malignancies (except cured basal cell skin cancer, cervical carcinoma in situ, Papillary carcinoma of thyroid gland, low-risk GIST etc.) within 5 years before study drug administration;
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- Patients who have undergone any major surgery (except needle biopsy, etc.) or severe trauma within 4 weeks before the first dose of BioTTT001;
- 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;
- NYHA≥grade 3; LVEF<50%; male QTc>450 mms, female QTc>470 mms;
- Patients with active tuberculosis or drug-induced interstitial lung disease；
- Patients with active infection requiring systemic anti-infective therapy;
- In a state of immunosuppression, such as severe combined immunodeficiency disease or concurrent opportunistic infections;
- HBsAg positive, and blood HBV DNA≥100 IU/mL; anti-HCV positive; HIV positive; active syphilis;
- Patients with pleural effusion and ascites with clinical symptoms that require repeated drainage;
- Patients with central nervous system metastases or meningeal metastases with clinical symptoms;
- Patients with contraindications to hepatic arterial perfusion therapy;
- Pregnant or lactating women;
- Patients with prior organ transplants;
- 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 Toripalimab and Regorafenib in Patients With Liver Metastases From Colorectal Cancer
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.
Read the detailed description
This study includes a dose escalation phase and a dose expansion phase. The dose escalation phase will adopt a 3+3 design. Subjects were first treated with BioTTT001 monotherapy (hepatic artery infusion, administered on D1 and D8 for a total of two doses) after enrollment. If the subject does not develop dose-limiting toxicity (DLT) in the monotherapy stage and is judged to be safe and tolerable by the investigator, the subject will enter the treatment phase of BioTTT001 in combination with toripalimab and regorafenib 2 weeks after the first dose of BioTTT001 ( toripalimab 160mg iv. D1 and D15 , BioTTT001 5×10^9 viral particle (VP)/5×10^10 VP/1×10^11 VP hepatic arterial infusion (HAI.) D2 and D16 , regorafenib 80 mg Po. D1-D21; 4 weeks per cycle). In the dose expansion phase, different dose groups can be expanded, and the total number of enrolled subjects is expected to be 23~48 for further safety, tolerability, pharmacokinetics and preliminary efficacy evaluation.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- BioTTT001 hepatic artery infusion, toripalimab, regorafenib
- Keywords
- oncolytic virus, colorectal Cancer, liver metastasis, hepatic artery infusion
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioTTT001 hepatic artery infusionBiological
BioTTT001 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.
toripalimabDrug
BioTTT001 in combination with toripalimab and regorafenib period: toripalimab 160mg intravenous D1 and D15, 4 weeks per cycle.
regorafenibDrug
BioTTT001 in combination with toripalimab and regorafenib period: regorafenib 80 mg oral administration, D1-D21, 4 weeks per cycle.
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy with BioTTT001 hepatic artery infusion , Regorafenib and Toripalimab | Experimental | This study includes a dose escalation phase and a dose expansion phase. The dose escalation phase will adopt a 3+3 design. Subjects were first treated with BioTTT001 monotherapy (hepatic artery infusion, administered on D1 and D8 for a total of two doses) after enrollment. If the subject does not develop dose-limiting toxicity (DLT) in the monotherapy stage and is judged to be safe and tolerable by the investigator, the subject will enter the treatment phase of BioTTT001 in combination with toripalimab and regorafenib 2 weeks after the first dose of BioTTT001 ( toripalimab 160mg iv. D1 and D15 , BioTTT001 5×10^9 viral particle (VP)/5×10^10 VP/1×10^11 VP hepatic arterial infusion (HAI.) D2 and D16 , regorafenib 80 mg Po. D1-D21; 4 weeks per cycle). In the dose expansion phase, different dose groups can be expanded, and the total number of enrolled subjects is expected to be 23~48 for further safety, tolerability, pharmacokinetics and preliminary efficacy evaluation. Receives: Biological: BioTTT001 hepatic artery infusion; Drug: toripalimab; Drug: regorafenib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
The incidence and severity of all types of adverse events evaluated based on NCI-CTCAE V5.0 assessment.
Measured: From the enrollment to 28 days after the end-of-trial visit (i.e. end of treatment or early termination visit)
MTD
Maximum tolerated dose (MTD)
Measured: 42 days within the first dose of BioTTT001 injection
Secondary outcomes (7)
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
Progression-free survival (PFS)
The time from the start of treatment to progress disease or death for any cause
Measured: At C1D28 of the combination therapy phase for the first time, and then every 8 weeks until disease progression, consent withdraw, death or end of study during the combination therapy phase, up to 100 weeks.
Objective response rate (ORR)
Objective response rate (ORR) as assessed by the investigators
Measured: Imaging will be performed at C1D28 of the combination therapy phase for the first time, and then every 8 weeks during the combination therapy phase.
Plasma adenovirus (ADV) copies
Pharmacokinetic Study (PK): Copies of ADV in plasma at various sampling points.
Measured: 8 days within the first BioTTT001 injection dose
ADV copies in various sites
Viral Shedding Analysis: Copies of ADV in swabs of rectal swabs, throat swabs, and urine samples at various sampling points.
Measured: 8 days within the first BioTTT001 injection dose
Serum IL-12 level
Expression levels of IL-12 at various sampling points in serum.
Measured: 8 days within the first BioTTT001 injection dose
Serum neutralizing antibody level
Immunogenicity assessment through adenovirus neutralizing antibody detection.
Measured: 8 days within the first BioTTT001 injection dose
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 startMar 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT06283134
- Sponsor's protocol ID
- BJCT-CMU1H-02
- Status last verified
- Jan 2026
- First submitted
- 22 Feb 2024
- Last updated
- 7 Jan 2026
- 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 7 Jan 2026. 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 Toripalimab and Regorafenib in Patients With Liver Metastases From Colorectal Cancer
- ClinicalTrials.gov ID
- NCT06283134
- Acronym / sponsor ID
- BJCT-CMU1H-02
- Conditions
- Colorectal Cancer Metastatic
- Keywords
- oncolytic virus, colorectal Cancer, liver metastasis, hepatic artery infusion
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Collaborators
- Beijing Bio-Targeting Therapeutics Technology Co., Ltd
- Study start
- Mar 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2028 (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, open-label clinical study of BioTTT001 in combination with Toraplizumab and Regorafenib in patients with liver metastases from colorectal cancer.
Detailed description
This study includes a dose escalation phase and a dose expansion phase. The dose escalation phase will adopt a 3+3 design. Subjects were first treated with BioTTT001 monotherapy (hepatic artery infusion, administered on D1 and D8 for a total of two doses) after enrollment. If the subject does not develop dose-limiting toxicity (DLT) in the monotherapy stage and is judged to be safe and tolerable by the investigator, the subject will enter the treatment phase of BioTTT001 in combination with toripalimab and regorafenib 2 weeks after the first dose of BioTTT001 ( toripalimab 160mg iv. D1 and D15 , BioTTT001 5×10^9 viral particle (VP)/5×10^10 VP/1×10^11 VP hepatic arterial infusion (HAI.) D2 and D16 , regorafenib 80 mg Po. D1-D21; 4 weeks per cycle). In the dose expansion phase, different dose groups can be expanded, and the total number of enrolled subjects is expected to be 23~48 for further safety, tolerability, pharmacokinetics and preliminary efficacy evaluation.
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 hepatic artery infusion , Regorafenib and Toripalimab | Experimental | Biological: BioTTT001 hepatic artery infusion, Drug: toripalimab, Drug: regorafenibThis study includes a dose escalation phase and a dose expansion phase. The dose escalation phase will adopt a 3+3 design. Subjects were first treated with BioTTT001 monotherapy (hepatic artery infusion, administered on D1 and D8 for a total of two doses) after enrollment. If the subject does not develop dose-limiting toxicity (DLT) in the monotherapy stage and is judged to be safe and tolerable by the investigator, the subject will enter the treatment phase of BioTTT001 in combination with toripalimab and regorafenib 2 weeks after the first dose of BioTTT001 ( toripalimab 160mg iv. D1 and D15 , BioTTT001 5×10^9 viral particle (VP)/5×10^10 VP/1×10^11 VP hepatic arterial infusion (HAI.) D2 and D16 , regorafenib 80 mg Po. D1-D21; 4 weeks per cycle). In the dose expansion phase, different dose groups can be expanded, and the total number of enrolled subjects is expected to be 23~48 for further safety, tolerability, pharmacokinetics and preliminary efficacy evaluation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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；
- ECOG 0~2；
Key exclusion criteria (19 listed)
- 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；
- Patients who have not recovered from the adverse reactions of previous treatments (the treatment-related toxicity ≤ grade 2, except for alopecia, pigmentation or other tolerable events judged by the investigator ).
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 hepatic artery infusionBioTTT001 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. | Biological | Combination therapy with BioTTT001 hepatic artery infusion , Regorafenib and Toripalimab |
| toripalimabBioTTT001 in combination with toripalimab and regorafenib period: toripalimab 160mg intravenous D1 and D15, 4 weeks per cycle. | Drug | Combination therapy with BioTTT001 hepatic artery infusion , Regorafenib and Toripalimab |
| regorafenibBioTTT001 in combination with toripalimab and regorafenib period: regorafenib 80 mg oral administration, D1-D21, 4 weeks per cycle. | Drug | Combination therapy with BioTTT001 hepatic artery infusion , Regorafenib and Toripalimab |
Primary outcome
Incidence of adverse events
Time frame: From the enrollment to 28 days after the end-of-trial visit (i.e. end of treatment or early termination visit)
The incidence and severity of all types of adverse events evaluated based on NCI-CTCAE V5.0 assessment.
MTD
Time frame: 42 days within the first dose of BioTTT001 injection
Maximum tolerated dose (MTD)
7 secondary outcomes
Overall survival(OS)
Time frame: Every 3 months until consent withdraw, death, withdrawal study, or loss of follow-up, up to 100 weeks
Progression-free survival (PFS)
Time frame: At C1D28 of the combination therapy phase for the first time, and then every 8 weeks until disease progression, consent withdraw, death or end of study during the combination therapy phase, up to 100 weeks.
Objective response rate (ORR)
Time frame: Imaging will be performed at C1D28 of the combination therapy phase for the first time, and then every 8 weeks during the combination therapy phase.
Plasma adenovirus (ADV) copies
Time frame: 8 days within the first BioTTT001 injection dose
ADV copies in various sites
Time frame: 8 days within the first BioTTT001 injection dose
Serum IL-12 level
Time frame: 8 days within the first BioTTT001 injection dose
Serum neutralizing antibody level
Time frame: 8 days within the first BioTTT001 injection dose
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 7 Jan 2026.
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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 1 study testing BioTTT001 hepatic artery infusion, toripalimab and regorafenib in people with Colorectal 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 8 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: opening soon, as of the sponsor's last update on 7 Jan 2026. 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 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?
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?
Incidence of adverse events (time frame: From the enrollment to 28 days after the end-of-trial visit (i.e. end of treatment or early termination visit)). The study lists 2 primary outcomes in all. 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 7 Jan 2026.