A Multicenter, Open Phase IIb Clinical Study to Evaluate the Efficacy and Safety of B1962 Injection in the Treatment of Advanced Colorectal Cancer

NCT06838546 | Not Yet Recruiting Phase 2

• 1 other identifier: TSL-B1962-03
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, randomized, open-label, two-stage Phase IIb clinical study to evaluate the efficacy and safety of B1962 in the treatment of advanced colorectal cancer. The subjects were patients with distant metastasis or unresectable locally advanced colorectal cancer who had previously failed oxaliplatin, irinotecan, fluorouracil-based drugs therapy containing disease progression or intolerable toxic side effects. Two dose groups were investigated: Dose group 1: B1962 35 mg/kg, intravenous infusion, Q2W, Dose group 2: B1962 45 mg/kg, intravenous infusion, Q2W.

Conditions

Advanced Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

  Proportion of patients who achieved complete response (CR) or partial response (PR) at two consecutive reviews ≥ 4 weeks apart.

  24 months

Study Arms (1)

B1962

EXPERIMENTAL

advanced colorectal cancer

Drug: B1962

Interventions

B1962 DRUG

B1962 has higher VEGF anti angiogenic activity than its competitors. Phase I clinical trials have shown that B1962 has excellent safety and promising therapeutic effects. Large scale clinical studies may achieve better therapeutic effects than similar competitors targeting the same target

Also known as: B1962 is a PD-L1/VEGF bispecific antibody fusion protein.

B1962

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must meet all of the following criteria to be eligible for enrollment in this study:
• Voluntary participation in the study and provision of signed and dated informed consent;
• Aged 18 to 75 years (inclusive) at the time of signing informed consent;
• Patients with distant metastasis or unresectable locally advanced colorectal cancer who have disease progression or intolerable toxicities after previous standard treatment must include oxaliplatin, irinotecan and fluorouracil-based drugs in previous standard treatment regimen;
• Histologically or cytopathologically confirmed adenocarcinoma of the colon or rectum, including adenocarcinoma of the appendix;
• Willingness to comply with protocol-specified visits, study treatment, laboratory tests, and other study-related procedures and requirements;
• Eastern Cooperative Oncology Group (ECOG) performance score 0-1;
• Expected survival time of more than 3 months;
• Presence of at least one measurable lesion (non-radiation field) confirmed by CT or MRI that meets RECIST v1.1 criteria;
• Adequate organ and bone marrow function:
• Hematologic system (no transfusion, no G-CSF use, no medication correction within 2 weeks prior to screening): absolute neutrophil count (ANC) ≥ 1.5 × 10 9/L, platelets (PLT) ≥ 75 × 10 9/L, hemoglobin (Hb) ≥ 90 g/L; Liver function: total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 3.0 × ULN, aspartate aminotransferase (AST) ≤ 3.0 × ULN; for patients with liver metastasis: ALT ≤ 5.0 × ULN, AST ≤ 5.0 × ULN; albumin ≥ 30 g/L; Renal function: creatinine within normal range, or creatinine clearance (Ccr) ≥ 60 mL/min (calculated according to Cockcroft-Gault formula); Cockcroft-Gault formula is: Ccr (ml/min) = \[(140-age) × weight (kg)× F\]/\[serum creatinine (mg/dl) × 72\] (F = 1 for males and 0.85 for females) Urine protein was qualitatively 0, ±, or \< 0.5 g/24 hours. All patients with urine protein(±) in urinalysis must have a 24-hour urine collection and must demonstrate urine protein \< 0.5 g/24 hours.
• Coagulation: prothrombin time (PT) ≤ 1.5 × ULN or international normalized ratio (INR) ≤ 1.5 × ULN, and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN;
• Fertile subjects agree to use highly effective contraception from signing the ICF and to avoid pregnancy during the study and for 3 months after the last dose (male or female subjects)
• Females of childbearing potential must be non-lactating and agree to use highly effective contraception from signing the ICF, and must practice contraception during the study and for 3 months after the last dose; blood pregnancy results (human chorionic gonadotropin hCG) must be negative within 7 days prior to enrollment;
• Females of non-childbearing potential (ie, physiologically incapable of becoming pregnant), including those who have been surgically sterilized (having undergone bilateral oophorectomy, bilateral tubal ligation, or hysterectomy), or who have been postmenopausal for ≥ 12 months prior to Screening (amenorrhea not due to treatment).

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from the study:
• Prior therapy targeting PD- (L) 1 and VEGF/VEGFR, including concurrent use of anti-PD-1/PD-L1 monoclonal antibody in combination with drugs targeting VEGF/VEGFR, or anti-PD-1/VEGF or anti-PD-L1/VEGF bispecific antibodies or bispecific fusion proteins, or sequential use of anti-PD-1/PD-L1 monoclonal antibody and drugs targeting VEGF/VEGFR;
• Received the last systemic anti-tumor treatment (biological agent therapy, etc.) within 4 weeks before the first dose, hormone anti-tumor treatment within 2 weeks before the first dose, non-specific immunomodulatory treatment (such as interleukin, interferon, thymosin, thalidomide, tumor necrosis factor, etc.) within 2 weeks before the first dose, and received Chinese herbal medicine or Chinese patent medicine with anti-tumor indications within 1 week before the first dose;
• Received systemic anti-tumor therapy in other clinical studies within 4 weeks prior to the first dose;
• Radiotherapy or surgery within 4 weeks prior to the first dose and diagnostic biopsy within 7 days prior to the first dose;
• Patients who have received live or attenuated vaccines within 4 weeks before screening or plan to receive live or attenuated vaccines during the study;
• Known hypersensitivity to the study drug or any of its components, or previous severe hypersensitivity to macromolecular protein preparations/monoclonal antibodies or bispecific antibodies;
• Adverse reactions from prior anticancer therapy that have not recovered to NCI-CTCAE v5.0 grade ≤ 1 (except alopecia, etc. for which the investigator considers there is no safety risk);
• Prior therapy with ≥ Grade 1 proteinuria, or prior bleeding event ≥ Grade 2 related to drugs targeting VEGF/VEGFR, or prior therapy with ≥ Grade 3 hypertension or ≥ Grade 3 immune-related adverse event.
• Known brain and/or leptomeningeal metastases;
• Patients with pleural effusion, pericardial effusion or peritoneal effusion accompanied by clinical symptoms, or pleural effusion, pericardial effusion or ascites that cannot be controlled by treatment of primary disease, anti-tuberculosis, anti-infection, diuretics or requires repeated drainage once every 3 weeks or more frequently;
• Complete or incomplete bowel obstruction or risk of bowel obstruction reported on imaging studies, presence of intra-abdominal abscess, or history of inflammatory bowel disease (eg, Crohn 's disease, ulcerative colitis);
• Screening imaging showed tumor encasing vital vessels or obvious necrosis and cavity, and the investigator judged that entering the study would cause bleeding risk, or tumor invading vital organs (such as heart and pericardium, trachea, esophagus) or risk of esophagotracheal fistula or esophagopleural fistula , ulcerated colorectal cancer or tumor infiltrating the full thickness of intestinal wall, or other lesions involving the gastrointestinal tract with bleeding or gastrointestinal fistula and gastrointestinal perforation risk;
• Known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive) or acquired immunodeficiency syndrome-related diseases, or other immunodeficiency diseases;
• Positive hepatitis B surface antigen (HBsAg), and HBV DNA higher than the upper limit of normal value of the detection unit; or positive hepatitis C antibody (HCV-Ab) and HCV-RNA quantification \> the upper limit of normal value of the detection unit; or known active syphilis infection;

Sponsors & Collaborators

• Tasly Biopharmaceuticals Co., Ltd.: lead
• Sir Run Run Shaw Hospital: collaborator

Study Sites (1)

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hanzhou, Hanzhou, 310009, China

Location

Central Study Contacts

qijing huang, Bachelor

CONTACT

13564643603; tsl-huangqj@tasly.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 20, 2025
• Study Start: February 24, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)