Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CTR20232532 | Other Identifier | ChinaDrugTrials |
Not provided
Not provided
Not provided
The research was terminated voluntarily due to changes in the company's business strategy regarding the development of BGB-24714, rather than any safety issues.
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 study aims to understand how safe and well-tolerated a drug called BGB-24714 is when used alone, or in combination with chemotherapy or radiation therapy, for people with advanced or spreading solid tumors. The main objective is to identify the highest tolerable dose or the highest administered dose of BGB-24714. Additionally, the study aims to identify the most suitable doses for further investigation in larger groups of participants.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1a: Dose Escalation Part A | Experimental | Participants will receive escalating doses of BGB-24714 as monotherapy |
|
| Phase 1a: Dose Escalation Part B | Experimental | Participants will receive increasing dose levels of BGB-24714 in combination with paclitaxel |
|
| Phase 1a: Dose Escalation Part C | Experimental | Participants will receive increasing dose levels of BGB-24714 in combination with chemoradiation |
|
| Phase 1a: Dose Escalation Part D | Experimental | Participants will receive increasing dose levels of BGB-24714 in combination with chemoradiation |
|
| Phase 1a: Dose Escalation Part A-CN | Experimental | Participants will receive escalating doses of BGB-24714 as monotherapy in Chinese participants |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGB-24714 | Drug | administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation: Number of participants with adverse events (AEs) | Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs ), and experiencing AEs meeting protocol defined Dose-Limiting Toxicity (DLT) criteria. | approximately 6 months |
| Dose Escalation: Maximum tolerated dose (MTD) of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with concurrent chemoradiotherapy (cCRT) | approximately 6 months | |
| Dose Escalation: Recommended Doses for Expansion (RDFE) of BGB-24714 as monotherapy, in combination with chemotherapy, and in combination with concurrent chemoradiotherapy (cCRT) | Recommended dose based upon the MTD or MAD, as well as the long-term tolerability, pharmacokinetics, efficacy, and any other relevant data as available | approximately 6 months |
| Dose Expansion: Objective response rate (ORR) | ORR is defined as the percentage of participants with partial or complete response, as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | approximately 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Dose Escalation: Objective response rate (ORR) | ORR is defined as the percentage of participants with partial or complete response, as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | approximately 2 Years |
| Dose Expansion: Progression-free Survival (PFS) |
Not provided
Key Eligibility Criteria :
Participants must sign a written informed consent form (ICF); and agree to comply with study requirement
Phase 1a (Dose Escalation):
Part A, A-CN, and B: Participants with histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumor previously treated with standard systemic therapy or for whom treatment is not available or not tolerated Note: Only Chinese participants will be eligible for Part A-CN.
Part C: Participant has histologically or cytologically confirmed, locally advanced, unresectable Stage III Non-small cell lung cancer (NSCLC) suitable for definitive chemoradiotherapy (CRT)
Part D: Participant with locally advanced, histologically confirmed inoperable esophageal squamous cell carcinoma (ESCC) suitable for definitive CRT
Phase 1b (Dose Expansion): Participants with histologically or cytologically confirmed solid tumors of selected types previously treated with standard therapy.
Participants must be able to provide formalin-fixed paraffin embedded (FFPE) tumor tissue sample.
Phase 1a Part A, A-CN, B and Phase 1b: ≥ 1 measurable lesion per Response evaluation criteria in solid tumors (RECIST) v1.1
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1
Key Exclusion Criteria:
NOTE: Other protocol defined inclusion/exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner Md Anderson Cancer Center | Gilbert | Arizona | 85234-2165 | United States | ||
| Florida Cancer Specialist (Scri) Sarasota |
BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
See plan description
See plan description
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Phase 1a: Dose Escalation Part E | Experimental | Participants will receive increasing dose levels of BGB-24714 in combination with chemoradiation in Chinese participants |
|
| Phase 1b: Dose Expansion | Experimental | BGB 24714 will be administered in combination with paclitaxel or docetaxel in participants with selected solid tumors. |
|
| Paclitaxel | Drug | administered intravenously |
|
| Carboplatin | Drug | administered intravenously |
|
| Docetaxel | Drug | administered intravenously |
|
PFS is defined as the time from the date of the first dose of study drug to the date of first documentation of disease progression as determined by the investigator using RECIST v1.1 or death, whichever occurs first |
| approximately 2 Years |
| Dose Expansion: Number of participants with adverse events | Number of participants with AEs and SAEs | approximately 2 Years |
| Duration of Response (DOR) | DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | approximately 2 Years |
| Disease Control Rate (DCR) | DCR is defined as the percentage of participants whose best overall response is complete response, partial response, or stable disease, as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | approximately 2 Years |
| Clinical Benefit Rate (CBR) | CBR is defined as the percentage of participants who have complete response, partial response, and stable disease, as determined by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) | approximately 2 Years |
| Plasma Concentrations of BGB-24714 and its metabolite | approximately 2 Years |
| Maximum Observed Plasma Concentration (Cmax) of BGB-24714 and its metabolite | Up to 48 hours postdose |
| Time to Maximum Plasma Concentration (Tmax) of BGB-24714 and its metabolite | Up to 48 hours postdose |
| Terminal Half-life (t1/2) of BGB-24714 and its metabolite | Up to 48 hours postdose |
| Area Under the Plasma Concentration Time Curve from Time 0 to the Last Quantifiable Concentration (AUC0-last) of BGB-24714 and its metabolite | Up to 48 hours postdose |
| Area Under The Plasma Concentration Time Curve From Time 0 To Infinity (AUC0-inf) of BGB-24714 and its metabolite | Up to 48 hours postdose |
| Apparent Clearance (CL/F) of BGB-24714 | Up to 48 hours postdose |
| Apparent Volume Of Distribution (Vz/F) of BGB-24714 | Up to 48 hours postdose |
| Concentration at steady state (Cmax,ss) of BGB-24714 and its metabolite | Up to 48 hours postdose |
| Time to Maximum Plasma Concentration at steady state (Tmax,ss) of BGB-24714 and its metabolite | Up to 48 hours postdose |
| Area Under the Plasma Concentration Time Curve from Time 0 to the Last Quantifiable Concentration at Steady State (AUClast,ss) of BGB-24714 and its metabolite | Up to 48 hours postdose |
| Rough Concentration At Steady State (Ctrough,ss) of BGB-24714 and its metabolite | Up to 48 hours postdose |
| Sarasota |
| Florida |
| 34232 |
| United States |
| Scri Florida Cancer Specialists North | St. Petersburg | Florida | 33705-1449 | United States |
| Scri Florida Cancer Specialist East | West Palm Beach | Florida | 33401-3406 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | 48201-2013 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601-1915 | United States |
| Upmc Hillman Cancer Center(Univ of Pittsburgh) | Pittsburgh | Pennsylvania | 15232-1309 | United States |
| Sanford Cancer Center | Sioux Falls | South Dakota | 57104-4663 | United States |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105-2108 | United States |
| Tennessee Oncology, Pllc Nashville | Nashville | Tennessee | 37203 | United States |
| Mary Crowley Cancer Research | Dallas | Texas | 75230 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390-7208 | United States |
| The University of Texas Md Anderson Cancer Center (Department Gi Medical Oncology) | Houston | Texas | 77030-4000 | United States |
| Intermountain Healthcare | Salt Lake City | Utah | 84143 | United States |
| Next Virginia | Fairfax | Virginia | 22031 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| Northern Beaches Hospital | Frenchs Forest | New South Wales | NSW 2086 | Australia |
| Icon Cancer Centre South Brisbane | South Brisbane | Queensland | QLD 4101 | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | QLD 4102 | Australia |
| Austin Health | Heidelberg | Victoria | VIC 3084 | Australia |
| Peter Maccallum Cancer Centre | Melbourne | Victoria | VIC 3000 | Australia |
| Sunshine Hospital | St Albans | Victoria | VIC 3021 | Australia |
| Chongqing Cancer Hospital | Chongqing | Chongqing Municipality | 400030 | China |
| Henan Cancer Hospital | Zhengzhou | Henan | 450000 | China |
| Hunan Cancer Hospital | Changsha | Hunan | 410013 | China |
| Shandong Provincial Hospital | Jinan | Shandong | 250021 | China |
| Shandong Cancer Hospital | Jinan | Shandong | 250117 | China |
| Auckland City Hospital | Auckland | 1023 | New Zealand |
| National Cancer Center (Korea) | IlsandongGu GoyangSi | Gyeonggi-do | 10408 | South Korea |
| Gachon University Gil Medical Center | NamdongGu | Incheon Gwang'yeogsi | 21565 | South Korea |
| Samsung Medical Center | GangnamGu | Seoul Teugbyeolsi | 06351 | South Korea |
| Severance Hospital Yonsei University Health System | SeodaemunGu | Seoul Teugbyeolsi | 03722 | South Korea |
| Asan Medical Center | SongpaGu | Seoul Teugbyeolsi | 05505 | South Korea |
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
Not provided
Not provided