A Multicenter, Open-label Phase IIa Clinical Study to Evaluate the Efficacy and Safety of B1962 I… (NCT06724263) | Clinical Trial Compass
Not Yet RecruitingPhase 2
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
China120 participantsStarted 2024-12
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. 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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Presence of at least one measurable lesion (non radiation therapy field) confirmed by CT or MRI that meets RECIST v1.1 criteria;
. Adequate organ and bone marrow function:
Exclusion criteria
. 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;