A Multicenter, Open-label Phase IIa Clinical Study to Evaluate the Efficacy and Safety of B1962 Injection in the Treatment of Advanced Malignant Solid Tumors

NCT06724263 | Not Yet Recruiting Phase 2

• 1 other identifier: TSL-B1962-02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a multicenter, open-label Phase IIa clinical study to evaluate the efficacy and safety of B1962 in the treatment of ad-vanced solid tumors. The study consists of a Screening Period, a Treatment Period, and a Follow-up Period (EOT Visit, Safety Follow-up, and Survival Follow-up). Subjects who meet the inclusion criteria and do not meet the exclusion criteria at screening will enter the appropriate study co-hort according to tumor type and receive B1962 until unacceptable toxicity, radiographic disease progression, or withdrawal of the sub-ject for other reasons, whichever comes first, for a maximum of 24 months of treatment. Enrollment will be conducted according to three stages: Stage I: It is planned to enroll 5 patients in each of 8 cohorts (tumor type) to observe the safety and efficacy; Stage II: 1 \~ 2 cohorts are preferred to enroll 15 \~ 20 patients to observe the ef-ficacy and safety; Stage III: 1 cohort is finally preferred to continue enrollment until a total of no more than 60 patients are observed in this cohort to observe the efficacy and safety.

Conditions

Recurrent Platinum-resistant Epithelial Ovarian Cancer; Triple Negative Breast Cancer (TNBC); Cervical Cancers; Small Cell Lung Cancer; Hepatocellular Carcinoma (HCC); Colorectal Cancer; Non-Squamous Non-Small Cell Lung 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 malignant neoplasm

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+
• 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;
• Age ≥ 18 years at the time of informed consent;
• Patients with histologically or cytologically confirmed advanced malignant solid tumors who have failed or failed to respond to first-line standard therapy, or cannot tolerate standard therapy, or have no standard effective treatment regimen, or refuse standard therapy; and no more than 4 lines of prior systemic anti-tumor therapy. Specific tumor species cohorts were as follows:
• Recurrent platinum-resistant epithelial ovarian cancer (including primary peritoneal and/or fallopian tube cancer): pathologically confirmed ovarian epithelial malignancy, fallopian tube epithelial malignancy, primary peritoneal cancer; and diagnosed platinum-resistant (duration of response to platinum-based therapy is within 6 months after the last dose of platinum-based therapy)
• Triple-negative breast cancer: pathologically confirmed unresectable locally advanced or metastatic breast cancer with negative ER, PR, and HER-2. ER, PR negativity was defined as: IHC ER \< 1%, IHC PR \< 1%. HER-2 negativity is defined as IHC HER-2 (-) or (1 +), and FISH must be performed and the result is negative for HER-2 (2 +) ③ Cervical cancer: pathologically confirmed inoperable locally advanced or metastatic cervical cancer
• Small-cell lung cancer: histologically or cytologically confirmed, inoperable, locally advanced or metastatic small-cell lung cancer
• ⑤ Biliary Tract Cancer: Pathologically confirmed unresectable locally advanced or metastatic biliary tract cancer, including gallbladder cancer and intrahepatic and extrahepatic cholangiocarcinoma
• ⑥ Hepatocellular carcinoma: pathologically confirmed hepatocellular carcinoma (excluding mixed hepatocellular carcinoma); Barcelona Clinic Liver Cancer (BCLC) stage C, not suitable for radical surgery and/or local treatment or stage B without radical progression after surgery and/or local treatment; Child-Pugh A liver function; for patients with esophagogastric varices, if gastroscopy or imaging, ultrasound and other examinations suggest severe (G3) varices or positive red sign, indicating high risk of venous bleeding, they are not allowed to participate in this study.
• ⑦ Colorectal cancer: pathologically confirmed unresectable locally advanced or metastatic colorectal cancer
• ⑧ Non-squamous non-small cell lung cancer: pathologically confirmed unresectable locally advanced or metastatic non-squamous non-small cell lung cancer that cannot contain a small cell lung cancer component.
• 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 therapy field) confirmed by CT or MRI that meets RECIST v1.1 criteria;

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from the study:
• Prior use of anti-PD-1 monoclonal antibody, anti-PD-L1 monoclonal antibody, or other antineoplastic agents containing PD- (L) 1 target;
• Patients who have previously used macromolecular VEGF/VEGFR inhibitors such as bevacizumab, ramucirumab;
• Known hypersensitivity to the study drug or any of its components, or previous severe hypersensitivity to macromolecular protein preparations/monoclonal antibodies or bispecific antibodies;
• Female patients are pregnant or lactating;
• Major surgery within 4 weeks prior to the first dose of study drug, or planned major surgery within the study period; For primary or metastatic liver cancer: local treatment of liver (such as transarterial chemoembolization, transcatheter embolization, hepatic arterial infusion, radiotherapy, radioembolization or radiofrequency ablation, etc.) within 4 weeks prior to the first dose of study drug;
• Adverse reactions from prior anticancer therapy that have not recovered to NCI-CTCAE v5.0 grade ≤ 1 (except alopecia and other for which the investigator considers there is no safety risk);
• Patients with clinical symptoms of brain metastases, spinal cord compression, carcinomatous meningitis, or patients with other evidence of uncontrolled brain or spinal cord metastases (except for stable symptoms and imaging studies showing stable disease for at least 4 weeks before the first dose);
• Patients with clinical symptoms or pleural effusion, pericardial effusion or ascites requiring repeated drainage;
• Screening imaging showed tumor encasing vital blood vessels or obvious necrosis and cavity, and the investigator judged that entering the study would cause bleeding risk; according to anatomical classification of tumor location, diagnosis of central lung cancer, or tumor involving hilum with bleeding risk.
• Known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive) or acquired immunodeficiency syndrome-related disease;
• 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;
• Uncontrolled bacterial, viral, fungal infections and other pathogen infections (such as mycoplasma, parasites, etc.) requiring systemic treatment within 4 weeks prior to the first dose of study drug;
• History of significant cardiovascular disease, including but not limited to: malignant arrhythmia requiring clinical intervention; or acute coronary syndrome (myocardial infarction and angina pectoris) within 6 months prior to the first dose; or congestive heart failure meeting New York Heart Association (NYHA) functional class II or higher criteria; or left ventricular ejection fraction (LVEF) \< 50%; poorly controlled hypertension with standard treatment or poor compliance with antihypertensive therapy; history of hypertensive crisis or hypertensive encephalopathy; and significant vascular disease (eg, aortic aneurysm requiring surgery);
• Patients with coagulation disorders, bleeding disorders, or other conditions judged by the investigator to be at risk of bleeding, such as skin wounds, surgical sites, wound sites, severe mucosal ulcers or fractures that have not healed completely, or active gastroduodenal ulcers, gastrointestinal bleeding, intestinal obstruction, ulcerative colitis, esophagogastric varices, gastrointestinal perforation within 6 months prior to the first dose;

Sponsors & Collaborators

• Tasly Biopharmaceuticals Co., Ltd.: lead
• Shanghai East Hospital: collaborator

Study Sites (1)

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200120, China

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Uterine Cervical Neoplasms; Small Cell Lung Carcinoma; Carcinoma, Hepatocellular; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Liver Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Lihong zheng, Bachelor

CONTACT

+8615010891603; zhenglh@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: November 28, 2024
• First Posted: December 9, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)