Not Yet RecruitingPhase 1

A Clinical Study of BioTTT001 in Combination With Toripalimab and Regorafenib in Patients With Colorectal Cancer

60 participantsStarted 2026-03

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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;
✕. 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;

What they're measuring

Incidence of adverse events

Timeframe: From the enrollment to 28 days after the end-of-trial visit (i.e. end of treatment or early termination visit)

MTD

Timeframe: 42 days within the first dose of BioTTT001 injection

Trial details

NCT IDNCT06283134

SponsorChina Medical University, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-01

Contact for this trial

Shuhui Song, bachelor

15004240769 593900927@qq.com

View on ClinicalTrials.gov More Colorectal Cancer Metastatic trials