Trials / Not Yet Recruiting
Not Yet RecruitingNCT06724263
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
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Tasly Biopharmaceuticals Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | B1962 | 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 |
Timeline
- Start date
- 2024-12-01
- Primary completion
- 2026-08-01
- Completion
- 2026-08-01
- First posted
- 2024-12-09
- Last updated
- 2024-12-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06724263. Inclusion in this directory is not an endorsement.