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Pusat Penelitian Uji Klinis

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PUSAT PENELITIAN UJI KLINIS

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Pusat Penelitian Uji Klinis Beacon Hospital didirikan pada tahun 2016. Kemudian pada tahun 2020, pusat penelitian klinis ini telah menjadi salah satu Pusat Keunggulan kami dengan tujuan membuat kami menjadi rumah sakit dengan integritas dan perilaku etika terpercaya secara global untuk penelitian klinis.

Uji klinis dan studi penelitian merupakan komponen kunci dari pendekatan penelitian berdasarkan bukti di Pusat Penelitian Klinis Beacon Hospital.

Dengan upaya kolektif yang dilakukan oleh pasien, tim spesialis onkologi, dan tim penelitian klinis kami, kami telah berkontribusi pada banyak uji klinis dan jumlah obat onkologi yang diluncurkan di Malaysia sangat mengesankan.

Ini dengan bangga membuat kami menjadi salah satu situs uji klinis teratas di Malaysia pada tahun 2021 di bidang onkologi, menurut laporan resmi dari Clinical Research Malaysia (CRM).

Mengapa Memilih Kami

Sejalan dengan fokus jangka panjang Pemerintah Malaysia untuk menjadikan negara sebagai pemain klinis penelitian yang signifikan secara global, kami berkomitmen untuk menemukan cara yang lebih baik untuk mengobati kanker dan membantu pasien kanker.

Selain fakta bahwa semua studi klinis kami telah mendapatkan persetujuan dari Komite Etik Medis dan Penelitian Kementerian Kesehatan Malaysia, kami juga mematuhi standar Praktik Klinis yang Baik (GCP) lokal dan internasional untuk menjaga kepentingan etis pasien uji coba.

Uji Coba Klinis yang Sedang Berlangsung

Hingga saat ini, tim onkologi kami telah berpartisipasi dalam banyak uji coba klinis, termasuk dalam membandingkan efektivitas perawatan kemoterapi yang berbeda; resistensi terhadap inhibitor; perubahan epigenetik pada kanker nasofaring; dan pengobatan untuk adenokarsinoma gastroesofageal lanjut atau metastatik, antara lain.

Daftar Uji Klinis

No.Clinical TrialStatusClinical Trial Gov
1CAPItello-292 A Phase Ib/III, Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in hormone receptor-positive and human epidermal growth factor receptor 2-negative locally advanced, unresectable or metastatic breast cancerActive (Recruiting)Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestran
2OPERA-01 A phase 3 randomized, open-label study of OP-1250 monotherapy vs SOC for the treatment of ER+, HER2- advanced or metastatic breast cancer following endocrine and CDK4/6 inhibitor therapyActive (Recruiting)Study of OP-1250 monotherapy vs SOC
3Elegant Elacestrant versus Standard Endocrine Therapy in Women and Men with Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer with High Risk of Recurrence - A Global, Multicenter, Randomized, Open-label Phase 3 Study (ELEGANT)Active (Recruiting)Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
4EPIK-B3 CBYL719H12301 (EPIK B3) - A Phase III, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with nab-paclitaxel in patients with advanced triple negative breast cancer with either phosphoinositide-3-kinase catalytic subunit alpha (PIK3CA) mutation or phosphatase and tensin homolog protein (PTEN) loss without PIK3CA mutation.ClosedStudy to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Nab-paclitaxel
5EPIK-B2 CBYL719G12301 (EPIK B2) – A two part, Phase III, multicenter, randomized (1:1), double-blind, placebo-controlled study to assess the efficacy and safety of alpelisib (BYL719) in combination with transtuzumab and pertuzumab as maintenance therapy in patients with HER2-positive advanced breast cancer with a PIK3CA mutation.ClosedStudy to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Trastuzumab
6lidERA A phase III, randomized, open-label, multicenter study evaluating the efficacy and safety of adjuvant giredestrant compared with physician's choice of adjuvant endocrine monotherapy in patients with estrogen receptor-positive, her2-negative early breast cancerClosedStudy Evaluating the Efficacy
7TENOR Phase II Study to assess the efficacy of Talazoparib in asian mEtastatic breast caNcer patients with a hOmologous Recombinant deficiency (HRD) signature (TENOR)ClosedNA

NoClinical TrialStatusClinical Trial Gov
1SOHO-02 A Phase 3 open-label, randomized, active-controlled, multicenter trial to evaluate the efficacy and safety of orally administered BAY 2927088 compared with standard of care as a first-line therapy in patients with locally advanced or metastatic non- small cell lung cancer (NSCLC) with HER2-activating mutations.Active (Recruiting)A Study to Learn More About How Well BAY 2927088 Works
2ATORG001 A prospective, molecular profiling study of mutational genes in Asian patients with Non-Small Cell Lung Cancer. (Non-interventional study).Active (Recruiting)Study of mutational genes in Asian patients
3ATORG004 Plasma Molecular Profiling in ALK inhibitor resistant non-small cell lung cancerActive (Recruiting)Plasma Molecular Profiling in ALK inhibitor resistant non-small cell lung cancer
4PACIFIC-8 A Phase 3, Randomised, Double blind, Placebo controlled, Multicentre, International Study of Durvalumab plus Domvanalimab (AB154) in Participants with Locally Advanced (Stage III), Unresectable Non small Cell Lung Cancer Whose Disease has not Progressed Following Definitive Platinum based Concurrent Chemoradiation Therapy (PACIFIC-8)Active (Recruiting)Study of Durvalumab plus Domvanalimab (AB154) in Participants with Locally Advanced
5MK3475-D46 Study of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50%Active (Recruiting)Study of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan
6Paloma-2 A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung CancerActive (Recruiting)Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors
7Tropion Lung-15 A Phase III, Open-label, Sponsor-blind, Randomized Study of Dato-DXd With or Without Osimertinib Versus Platinum-based Doublet Chemotherapy for Participants with EGFR-mutated Locally Advanced or Metastatic Non-small Cell Lung Cancer whose Disease has Progressed on Prior Osimertinib Treatment (TROPION-Lung15)rActive (Recruiting)Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
8BGB-LC-201 A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung CancerClosedStudy of Tislelizumab in Combination With Investigational Agents
9Jimmy Lung A randomized, double-blind, parallel-group study to compare efficacy, safety, and immunogenicity of GME751 (proposed pembrolizumab biosimilar) and EU-authorized Keytruda® in adult participants with untreated metastatic non-squamous non-small cell lung cancer (NSCLC)ClosedA Study to compare efficacy, safety, and immunogenicity of GME751
10INSIGHT-2A Phase II, two-arm study to investigate tepotinib combined with osimertinib in MET amplified, advanced or metastatic non-small cell lung cancer (NSCLC) harboring activating EGFR mutations and having acquired resistance to prior osimertinib therapyClosedStudy to investigate tepotinib combined with osimertinib in MET amplified, advanced or metastatic non-small cell lung cancer (NSCLC)
11LAURA A Phase III, randomized, double-blind, placebo-controlled, multicenter, international study of osimertinib as maintenance therapy in patients with locally advanced, unresectable EGFR mutation-positive on-Small Cell Lung Cancer (Stage III) whose disease has not progressed following definitive platinum-based chemoradiation therapy.ClosedStudy of osimertinib as maintenance therapy in patients with locally advanced
12MARIPOSA A Randomized Study of JNJ-61186372 and Lazertinib Combination Therapy Versus Single Agent Osimertinib or Lazertinib as First-Line Treatment in Patients with EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer.ClosedStudy of JNJ-61186372 and Lazertinib Combination Therapy Versus Single Agent Osimertinib or Lazertinib as First-Line Treatment
13ATORG003 A single-arm, open-label, phase 2 study of Dacomitinib with or without dose titration for the first-line treatment of locally advanced or metastatic non-small cell lung cancer in subjects with an epidermal growth factor receptor (egfr) activation mutationClosedStudy of Dacomitinib with or without dose titration for the first-line treatment of locally advanced
14ML41262 A Prospective, Multicentre, Genomic Profiling Study In Patients With Locally Advanced Or Metastatic Non-small Cell Lung Cancer (NSCLC) In Malaysia Using Foundation MedicineClosed-
15INCMGA 0012-304 A Randomized, Double Blind, Phase 3 Study of Platinum-based Chemotherapy with or without INCMGA00012 in First-Line Metastatic Squamous and Nonsquamous Non-Small Cell Lung Cancer ParticipantsClosedStudy of Platinum-based Chemotherapy with or without INCMGA00012
16PFIZER A7471067 Real-world utilization and outcomes with “study drug” first-line treatment for EGFR mutation-positive advanced non-small cell lung cancer among Asian patients – A multi-center chart reviewClosedReal-world utilization and outcomes with “study drug” first-line treatment
17MK7684A-002 A Phase II, multicenter, randomized study to compare the efficacy and safety of MK-7684A or MK-7684A plus Docetaxel versus Docetaxel monotherapy in the treatment of participants with metastatic non-small cell lung cancer with progressive disease after treatment with a platinum doublet chemotherapy and immunotherapyClosedStudy to compare the efficacy and safety of MK-7684A or MK-7684A plus Docetaxel
18MARIPOSA2 A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy Compared With Platinum-Based Chemotherapy in Patients With Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non- Small Cell Lung Cancer After Osimertinib FailureClosedA Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy
19ADAURA-2 D516FC00001 - A Phase III, Double-blind, Randomized, Placebo-Controlled, International Study to assess the Efficacy and Safety of Adjuvant Osimertinib versus Placebo in Patients with EGFR mutation-positive, Stage IA2-IA3 Non-small Cell Lung Cancer, following Complete Tumor ResectionClosedStudy to assess the Efficacy and Safety of Adjuvant Osimertinib
20kontRASt-02 CJDQ443B12301 : A randomized, controlled, open label, phase III study evaluating the efficacy and safety of JDQ443 versus docetaxel in previously treated subjects with locally advanced or metastatic KRAS G12C mutant non-small cell lung cancerClosedA randomized, controlled, open label, phase III study evaluating the efficacy and safety of JDQ443
 

NoClinical TrialStatusClinical Trial Gov
1MO42541A phase III, open-label, randomized study of atezolizumab with lenvatinib or sorafenib versus lenvatinib or sorafenib alone in HCC previously treated with atezolizumab and bevacizumabClosedStudy of atezolizumab with lenvatinib or sorafenib

NoClinical TrialStatusClinical Trial Gov
1Origami-1A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal CancerClosedStudy of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy
2MK4280A-007A Phase 3 study of MK-4280A (coformulated favezelimab [MK-4280] plus pembrolizumab [MK-3475]) Versus Standard of Care in Previously Treated Metastatic PD-L1 positive Colorectal CancerClosedStudy of atezolizumab with lenvatinib or sorafenib
3Krystal-10A Randomized Phase 3 Study of MRTX849 in Combination with Cetuximab Versus Chemotherapy in Patients with Advanced Colorectal Cancer with KRAS G12C Mutation with Disease Progression On or After Standard First-Line TherapyClosedStudy of MRTX849 in Combination with Cetuximab

NoClinical TrialStatusClinical Trial Gov
1PRL3-ZumabAn Open Label, Multicenter, Safety and Efficacy Phase II/III Study of PRL3-Zumab in Solid Tumors PatientsClosedNA

NoClinical TrialStatusClinical Trial Gov
1GCT3014-01An Open-Label, Multicenter, Phase 1/2 Study of GEN3014 (HexaBody®-CD38) in Relapsed or Refractory Multiple Myeloma and Other Hematologic MalignanciesClosedStudy of GEN3014 (HexaBody®-CD38)
2IMR BortezomibGenetic Variation Associated with Bortezomib Induced Peripheral Neuropathy in Adult Multiple Myeloma Patients (Investigator initiated study)ClosedNA

NoClinical TrialStatusClinical Trial Gov
1CAAA617D12302An International, Prospective, Open-label, Multi-center, Randomized Phase III Study comparing lutetium (177Lu) vipivotide tetraxetan (AAA617) versus Observation to delay castration or disease recurrence in adult male patients with prostate-specific membrane antigen (PSMA) positive Oligometastatic Prostate Cancer (OMPC)Active (Recruiting)An Open-label Study Comparing Lutetium (177Lu) Vipivotide Tetraxetan Versus Observation in PSMA Positive OMPC

Daftar Publikasi

Terlepas dari uji klinis onkologi, konsultan kami dari pusat keunggulan lain juga telah memberikan kontribusi besar untuk spesialisasi klinis mereka dengan penelitian yang dilakukan serta dipublikasikan.
Di bawah ini adalah publikasi penelitian (abstrak, makalah penelitian, presentasi poster, dan lainnya ) yang dihasilkan oleh konsultan kami:

NoPublication TitleName of ConsultantType of Presentation
1Tepotinib plus osimertinib in patients with EGFR-mutated non-small-cell lung cancer with MET amplification following progression on first-line osimertinib (INSIGHT 2): a multicentre, open-label, phase 2 trialDr Tho Lye Mun (Consultant Clinical Oncologist)Original Article
2Effectiveness of adjunctive ultrasound after mammography in improving breast cancer screening findings from a study in Malaysian womenMohamed Ibrahim Wahid, Nurul Alia Azmi, Pei Yun Tan, Bao Jing Chen,Original Article
3Topical nonsteroidal anti‐inflammatory drugs for management of osteoarthritis pain: A consensus recommendationJoon-Kiong Lee, Azlina A.Abbas, Tien-Eang Cheah, Ruslan Nazaruddin Simanjuntak, Sargunan Sockalingam, Sharifah RoohiOriginal Article
4Retrospective Analysis of Clinical Outcomes of Stereotactic Body Radiation Therapy for Localized Prostate Cancer at an Asian Cancer Specialist CentreJasmin Loh Pei Yuin, Jessica Tan Jia Shin, Chen Bao Jing, Tho Lye Mun, Manivanna Arkonam Balasubramaniam, Dato Mohamed Ibrahim WahidOriginal Article
5KASRPImpact of a digital educational program on nurses’ knowledge and attitudes toward pain assessment and management in a Malaysian hospital.Dr Koon Sim Lan Jessica Tan Jia Shin, Ph.D ( Clinical Informatics Specialist)
6Presenting complaints of patients and palliative care referral patternsDr Felicia Chang Dr Azura Jessica Tan Jia Shin, Ph.D (Clinical Informatics Specialist)
7Breast cancer survivorship in an Asian specialist centre from Malaysia: A retrospective analysisDato Ibrahim Dr Azura Arkonam Balasubramaniam Manivannan (Consultant Oncologists) Jessica Tan Jia Shin. Ph. D (Clinical Informatics Specialist) Original Article
8Does A Picture Really Paint A Thousand Words? A Study On The Technical Qualities Of Online Aesthetic Oculofacial Clinical PhotographsDr Ong Chin Tuan (Consultant Ophthalmologist) Poster
9Healthcare Performance Measurement And Reporting For Breast Cancer Services in Malaysia
10Healthcare Performance Measurement And Reporting System (HPMRS) For Cancer Care

Jika anda tertarik dan ingin mengetahui lebih lanjut mengenai uji coba klinis yang sedang berlangsung, silahkan hubungi kami di +603-7787 2830 atau anda dapat mengirim email pada kami di clinicalresearch@beaconhospital.com.my.

Beacon Hospital Independent Ethics Committee

Tentang Komite Etik Independen Rumah Sakit Beacon (BH-IEC)

Komite Etik Independen Beacon Hospital merupakan badan independen yang terdiri dari individu yang terlatih secara profesional dalam disiplin medis, ilmuwan non-medis, anggota non-ilmiah, dan orang awam yang bertanggung jawab untuk memastikan perlindungan hak, keselamatan, dan kesejahteraan subjek manusia yang terlibat dalam uji klinis.

Komite ini menjalankan tanggung jawab tersebut dengan meninjau, menyetujui, dan memberikan tinjauan berkelanjutan atas protokol uji klinis dan amandemennya.

Selain itu, komite juga mengevaluasi metode dan materi yang akan digunakan dalam memperoleh dan mendokumentasikan persetujuan yang diinformasikan dari subjek uji klinis.

BH-IEC beroperasi dengan mematuhi standar etika lokal dan internasional secara ketat dan menjalani pemeriksaan regulasi sesuai pedoman nasional. Uji klinis dilakukan sesuai dengan prinsip etika yang berasal dari Deklarasi Helsinki, dan yang konsisten dengan Praktik Klinis yang Baik (GCP) dan persyaratan regulasi yang berlaku di negara tersebut.

Otoritas BH-IEC

BH-IEC diberi mandat untuk melaksanakan tanggung jawab berikut:

Tinjauan Protokol Penelitian

Meninjau uji klinis yang diusulkan dalam waktu yang wajar dan mendokumentasikan pandangannya secara tertulis, dengan jelas mengidentifikasi uji coba, dokumen yang ditinjau dan tanggal persetujuan, modifikasi studi, atau ketidaksetujuan untuk memastikan bahwa semua itu sesuai dengan standar dan pedoman etika.

Persetujuan berdasarkan informasi

Mengevaluasi dokumen dan prosedur persetujuan untuk memastikan bahwa dokumen dan prosedur tersebut komprehensif dan dapat dimengerti oleh peserta.

Pemantauan Studi

Melakukan tinjauan berkelanjutan terhadap setiap uji coba yang sedang berlangsung dengan interval yang sesuai dengan tingkat risiko terhadap subjek manusia, tetapi setidaknya setahun sekali.

Perlindungan Peserta

Memastikan hak-hak, keselamatan, dan kesejahteraan peserta penelitian dilindungi selama penelitian berlangsung. Perhatian khusus diberikan pada uji coba yang mungkin melibatkan subjek yang rentan.

Evaluasi Independen

Memberikan pendapat yang independen, obyektif, dan tidak bias mengenai isu-isu etis yang terkait dengan kegiatan penelitian.

Kompensasi kepada Subjek

Meninjau jumlah, metode, dan jadwal pembayaran untuk memastikan bahwa tidak ada masalah pemaksaan atau pengaruh yang tidak semestinya terhadap subjek penelitian.

Member (Title and Name)Occupation (Designation)Male/Female (M/F)
Chairperson: Dr. Tho Lye MunConsultant Clinical Oncologist, Beacon HospitalMale
Deputy Chairman: Dato’ Dr Lee Joon KiongDeputy Medical Director, Consultant Orthopaedic Surgeon, Beacon HospitalMale
Secretary (non-voting): R Suntari RamachandranAssistant Manager, Clinical Research, Beacon HospitalFemale
Secretary (non-voting): Grace Kong Kah YiClinical Research Coordinator, Beacon HospitalFemale
(Scientific / Medical) Dato' Dr Anuar Zaini Md ZainProfessor of Internal Medicine at Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Consultant Endocrinologist, Beacon HospitalMale
(Scientific / Medical) Dr. Leong Kok WengConsultant Anaesthesiologist, Beacon HospitalMale
(Scientific / Medical) Dr. Tengku Ahmad HidayatConsultant Hematologist, Beacon HospitalMale
(Scientific / Medical) Dr. Koon Sim LanConsultant Palliative Medicine, Beacon HospitalFemale
(Non-Scientific / Medical) Wong Mei TengManager of Medical Services Development DepartmentFemale
(Non-Scientific / Non-Medical) Helen WongLegal RepresentativeFemale
(Scientific / Non-Medical) Quah Sean IRepresentative of Head, Department of PharmacyFemale
(Non-Scientific / Non-Medical) Yong Lee LeePublic RepresentativeFemale
Comment: The duration of membership will be two (2) years

BH-IEC Deadline and Meeting Schedule

MonthMeeting Date (subject to change)Submission Date
January23 January 20269 January 2026
February27 February 202613 February 2026
March20 March 20266 March 2026
April24 April 202610 April 2026
May22 May 20268 May 2026
June19 June 20265 June 2026
July24 July 202610 July 2026
August21 August 20267 August 2026
September18 September 20264 September 2026
October23 October 20269 October 2026
November20 November 20266 November 2026
December18 December 20264 December 2026

MonthMeeting Date (subject to change)Submission Date
January24 January 202510 January 2025
February21 February 20257 February 2025
March21 March 20257 March 2025
April25 April 202510 April 2025
May23 May 20259 May 2025
June20 June 20256 June 2025
July25 July 202510 July 2025
August22 August 20258 August 2025
September26 September 202510 September 2025
October24 October 202510 October 2025
November21 November 20257 November 2025
December26 December 202510 December 2025

MonthMeeting Date (subject to change)Submission Date
December27 December 202410 December 2024

Note

  • The dates of the BH-IEC Meetings are subject to change.
  • The average duration for review of a new study from the receipt of an application by the secretariat to the IEC’s first decision is 60 days. Please plan your study submissions based on the turnaround time for study applications.
  • Applicants are advised to contact the BH-IEC secretariat to confirm the meeting dates and application due date.

BH-IEC Secretariat

Sorotan Terbaru
Pusat Keunggulan

Informasi

Jam Kunjungan:
10:00 – 22:00
Saluran Umum:
+603 7620 7979 +603 7787 2992
Saluran Janji Temu Konsultan:
+603 7118 7878 +6012 328 6913
Email:
info@beaconhospital.com.my
Pertanyaan Karir / SDM:
joinus@beaconhospital.com.my

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Tetap terinformasi dengan tren kesehatan terbaru, saran ahli, dan acara terkini di Rumah Sakit Beacon.
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