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| Name | Class |
|---|---|
| Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. | INDUSTRY |
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This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with HER2-expressing platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
In this trial, the treatment group will receive BL-M07D1, while the control group will receive physician's choice of chemotherapy (liposomal doxorubicin, paclitaxel, or topotecan).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BL-M07D1 | Experimental | Participants receive BL-M07D1 in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. |
|
| physician's choice of chemotherapy | Active Comparator | Participants receive liposomal doxorubicin, paclitaxel or topotecan in the first cycle (4 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BL-M07D1 | Drug | Administration by intravenous infusion for a cycle of 3 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death. | Up to approximately 24 months |
| Overall survival (OS) | Overall survival (OS) is defined as the time between the subject's randomization date and subject's death. | Up to approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS). | Up to approximately 24 months |
| Disease Control Rate (DCR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sa Xiao, PHD | Contact | 15013238943 | xiaosa@baili-pharm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | China |
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| Liposomal Doxorubicin |
| Drug |
Administration by intravenous infusion for a cycle of 4 weeks. |
|
| Paclitaxel | Drug | Administration by intravenous infusion for a cycle of 4 weeks. |
|
| Topotecan | Drug | Administration by intravenous infusion for a cycle of 4 weeks. |
|
Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria. |
| Up to approximately 24 months |
| Duration of Response (DOR) | Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death. | Up to approximately 24 months |
| Response Rate (RR) | Response Rate (RR) is defined as the proportion of subjects whose overall response is assessed as remission according to the RECIST v1.1 and GCIG CA-125 criteria. | Up to approximately 24 months |
| CA-125 Response Rate | CA-125 Response Rate is defined as the proportion of subjects who achieve a response according to the GCIG CA-125 criteria. | Up to approximately 24 months |
| Treatment Emergent Adverse Event (TEAE) | TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-M07D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M07D1. | Up to approximately 24 months |
| Anti-drug antibody (ADA) | Frequency of anti-BL-M07D1 antibody (ADA) will be investigated. | Up to approximately 24 months |
| Yunnan Cancer Hospital | Kunming | Yunnan | China |
|
| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010051 | Ovarian Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D005184 | Fallopian Tube Diseases |
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| ID | Term |
|---|---|
| C506643 | liposomal doxorubicin |
| D017239 | Paclitaxel |
| D019772 | Topotecan |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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