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BGB-290

Phase 2

HER2-negative Breast Cancer | Small molecule | Oncology |BeOne Medicines Ltd.|Last Updated: Dec 27, 2024

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment88

FDA Designations

No designations recorded

Clinical trial landscape

BGB-290 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT03575065Efficacy and Safety of BGB-290 in the Treatment of Metastatic HER2-Negative Breast Cancer Patients With BRCA Mutation in ChinaHER2-negative Breast Cancer
COMPLETED88 Analytics
PHASE2COMPLETED
Efficacy and Safety of BGB-290 in the Treatment of Metastatic HER2-Negative Breast Cancer Patients With BRCA Mutation in China
HER2-negative Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective Response Rate (ORR) as Assessed by Independent Radiology Review (IRC)
From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 4 months)

ORR is defined as the percentage of participants who achieved a best overall response of confirmed complete response (CR) or partial response (PR), assessed by IRC per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

Objective response rate ([ORR]: Complete Response (CR) + Partial Response (PR)) based on RECIST Version 1.1
through study completion, an average of 1 year

The primary endpoint of the study was a composite response rate that included ORR, a ≥50% decrease in serum prostate-specific antigen (PSA), and/or a decrease in circulating tumor cells.

Prostate-specific antigen (PSA) response (for prostate cancer participants only) based on Prostate Cancer Working Group 2 (PCWG2) criteria
through study completion, an average of 1 year

The primary endpoint of the study was a composite response rate that included ORR, a ≥50% decrease in serum prostate-specific antigen (PSA), and/or a decrease in circulating tumor cells.

Primary PK 1
through study completion, an average of 1 year

Primary PK parameter is area under the plasma concentration time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUClast).

Primary PK 2
through study completion, an average of 1 year

Primary PK parameter is area under plasma concentration time curve (AUC).

Primary PK 3
through study completion, an average of 1 year

Primary PK parameter is maximum observed plasma concentration (Cmax).

Secondary Endpoints

ORR as Assessed by Investigator
From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 10 months)
Progression-free Survival (PFS) as Assessed by IRC and Investigator
From the first dose of pamiparib to first documentation of disease progression or death (Approximately 2 years and 10 months)
Duration of Response (DOR) as Assessed by IRC
From first documentation of confirmed CR or PR to first documentation of disease progression or death (Approximately 2 years and 10 months)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohort 1: Triple-negative breast cancer (TNBC)EXPERIMENTALLocally advanced or metastatic TNBC
Cohort 2: HR(+)/HER2(-) breast cancerEXPERIMENTALLocally advanced or metastatic Hormone receptor-positive(HR+) human epidermal growth factor receptor2 Negative(HER2-) breast cancer
ovarian cancer, fallopian cancer, or primary peritoneal cancerEXPERIMENTAL60mg BID oral.
Breast CancerEXPERIMENTAL60mg BID Ora
Prostate CancerEXPERIMENTAL60mg BID Oral
Small Cell Lung CancerEXPERIMENTAL60mg BID Oral
Gastric CancerEXPERIMENTAL60mg BID Oral

Interventions

NameTypeDescription
BGB-290DRUGAdministered orally
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: 1. Confirmed deleterious or suspected deleterious germline BRCA1 or BRCA2 mutation 2. Locally advanced or metastatic breast cancer despite standard therapy and the following: 1. Histologically or cytologically confirmed HER2(-) breast cancer (TNBC or estrogen receptor-positi...

Countries:ChinaAustralia
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Frequently asked questions about BGB-290

What is BGB-290 used for?

BGB-290 is an investigational small molecule being studied in oncology. It has been evaluated in a Phase 1 trial for participants with advanced solid tumors who failed previous lines of treatment, and in a Phase 2 trial for metastatic HER2-negative breast cancer patients with BRCA mutations in China.

Who makes BGB-290?

BGB-290 is being developed by BeOne Medicines Ltd., which trades under the ticker ONC. The company is conducting clinical trials for this investigational oncology drug.

What phase is BGB-290 in?

BGB-290 has completed a Phase 1 trial (NCT02361723) for advanced solid tumors and a Phase 2 trial (NCT03575065) for HER2-negative breast cancer. It is an investigational drug still in clinical development and is not FDA approved.

What clinical trials is BGB-290 in?

BGB-290 has been studied in two completed trials: NCT02361723, a Phase 1a/1b trial for advanced solid tumors in Australia with 101 participants, and NCT03575065, a Phase 2 trial for metastatic HER2-negative breast cancer with BRCA mutations in China with 88 participants.

Is BGB-290 the same as pamiparib?

BGB-290 is the code name for the drug also known as pamiparib. It is a small molecule being developed by BeOne Medicines Ltd. for oncology indications, including advanced solid tumors and HER2-negative breast cancer.