Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is an open-label, phase Ib/II, multi-center study to evaluate efficacy and safety of KN046 alone or in combination with nab-paclitaxel in subjects with locally advanced unresectable or metastatic triple negative breast cancer (TNBC). The study is composed of dose escalation and expansion parts. Every subject will subject tumor tissue used for biomarker evaluation. Each subject will receive KN046 or in combination with nab-paclitaxel untill confirmed progressive disease, unacceptable toxicity or withdrawal of informed consent whichever occurs first.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KN046 | Experimental | Subjects will receive KN046 at a dose of 3 mg/kg or 5 mg/kg via intravenous infusion on Days 1 and 15 of every 28-day cycle until disease progression, unacceptable toxicity or completion of 2 years of treatment |
|
| KN046 plus nab-paclitaxel | Experimental | Subjects will receive KN046 at a dose of 3 mg/kg or 5 mg/kg via intravenous infusion on Days 1 and 15 of every 28-day cycle until disease progression, unacceptable toxicity or completion of 2 years of treatment Subjects will receive nab-paclitaxel at a dose of 100 mg/m2 via intravenous infusion on Days 1, 8 and 15 of every 28-day cycle until disease progression or unacceptable toxicity |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KN046 | Biological | KN046 at a dose level of 3 or 5 mg/kg via intravenous infusion on Days 1 and 15 of 28-day cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| IRC assessed objective response | Objective response is defined as complete response (CR) or partial response (PR), as determined by the independent review committee using RECIST v1.1 criteria. CR is defined as the disappearance of all TLs and SA reduction to less than (<) 10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD | From Day 1 to PD, assessed up to 12 months after last patient last dose |
| IRC assessed duration of response | Duration of response is defined as the time period from the date of initial independent review committee assessed CR or PR until the date of PD or death from any cause, whichever occurs first. CR is defined as the disappearance of all TLs and SA reduction to <10mm for nodal TLs/ non-TLs. PR is defined as >/=30% decrease in SD of TLs, taking as reference the baseline SD. PD is defined as >/=20% relative increase and >/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions | From Day 1 to PD, assessed up to 12 months after last patient last dose |
| Measure | Description | Time Frame |
|---|---|---|
| PFS rate at 6 and 12 months | PFS is defined as the time from Day 1 to the first occurrence of PD, as determined by the independent review committee or investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (>/=) 20 percent (%) relative increase and >/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions. PFS rate at 6 and 12 months is defined as percentage of subjects who are alive without progressive disease or death at 6 and 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38310192 | Derived | Li Q, Liu J, Zhang Q, Ouyang Q, Zhang Y, Liu Q, Sun T, Ye F, Zhang B, Xia S, Zhang B, Xu B. The anti-PD-L1/CTLA-4 bispecific antibody KN046 in combination with nab-paclitaxel in first-line treatment of metastatic triple-negative breast cancer: a multicenter phase II trial. Nat Commun. 2024 Feb 3;15(1):1015. doi: 10.1038/s41467-024-45160-y. |
Not provided
Not provided
all IPD that underlie results in a publication
6 months after publication
Health care professionals or researches may raise request to Sponsor to have access to study report, sub-group analysis
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Nab-paclitaxel | Drug | Nab-paclitaxel at dose level of 100 mg/m2 via intravenous infusion on Days 1, 8 and 15 of 28-day cycle |
|
| From Day 1 to disease progression (PD) or death from any cause, assessed up to 12 months after last patient last dose |
| Frequency and severity of treatment emergent adverse events | Treatment emergent adverse event is defined as those events with onset days occurring during the on-treatment period till 90 days after last dose of KN046 or if the worsening of an event is during the on-treatment period till 90 days after last dose of KN046 | From Day 1 to 90 days after last dose of KN046, through study completion, an average of 1 year |
| Percentage of subjects with anti-drug antibodies | ADA is defined as human anti-drug antibodies | Day 1 (pre-dose) to 90 days after last dose of KN046, through study completion, an average of 1 year |
| The First Affiliated Hospital of Xiamen University | Xiamen | Fujian | China |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou | Guangdong | China |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | China |
| Harbin Medical University Cancer Hospital | Harbin | Heilongjiang | China |
| Henan Cancer Hospital | Zhengzhou | Henan | China |
| Hunan Cancer Hospital | Changsha | Hunan | China |
| Nantong Tumor Hospital | Nantong | Jiangsu | China |
| JiLin Cancer Hospital | Changchun | Jilin | China |
| Liaoning Cancer Hospital | Shenyang | Liaoning | China |
| LiaoCheng People's Hospital | Liaocheng | Shandong | China |
| Zibo Municipal Hospital | Zibo | Shandong | China |
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C520255 | 130-nm albumin-bound paclitaxel |
Not provided
Not provided
Not provided