Clinical trials are crucial to Beacon Hospital’s research center as such the elevation to being a Centre of Excellence (COE) in 2020.
Our patients, oncology team, and research team have played a pivotal role in contributing to multiple clinical trials and facilitating the launch of numerous oncology drugs in Malaysia.
In 2021, we were recognized as one of the leading oncology clinical trial sites in Malaysia by Clinical Research Malaysia.
Aligned with Malaysia’s global clinical research aspirations, we’re dedicated to finding better ways to treat cancer and help cancer patients.
Our studies are approved by the Ministry of Health’s Ethics Committee, and we adhere to Good Clinical Practice standards, prioritizing ethical considerations for trial patients.
To date, our oncology team has participated in numerous clinical trials including in comparing the effectiveness of different chemotherapy treatments; resistance to inhibitors; epigenetic changes in nasopharyngeal cancer; and treatment for advanced or metastatic gastroesophageal junction adenocarcinoma, among others.
| No. | Clinical Trial | Status | Clinical Trial Gov |
|---|---|---|---|
| 1 | CAPItello-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 cancer |
Active (Recruiting) | Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestran |
| 2 | OPERA-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 therapy |
Active (Recruiting) | Study of OP-1250 monotherapy vs SOC |
| 3 | EPIK-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. |
Closed | Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Nab-paclitaxel |
| 4 | EPIK-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. |
Closed | Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Trastuzumab |
| 5 | lidERA 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 cancer |
Closed | Study Evaluating the Efficacy |
| 6 | TENOR Phase II Study to assess the efficacy of Talazoparib in asian mEtastatic breast caNcer patients with a hOmologous Recombinant deficiency (HRD) signature (TENOR) |
Closed | NA |
| No | Clinical Trial | Status | Clinical Trial Gov |
|---|---|---|---|
| 1 | SOHO-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 |
| 2 | ATORG001
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 |
| 3 | ATORG004
Plasma Molecular Profiling in ALK inhibitor resistant non-small cell lung cancer |
Active (Recruiting) | Plasma Molecular Profiling in ALK inhibitor resistant non-small cell lung cancer |
| 4 | PACIFIC-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 |
| 5 | MK3475-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 |
| 6 | Paloma-2
A Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors Including Epidermal Growth Factor Receptor (EGFR)-Mutated Non-Small Cell Lung Cancer |
Active (Recruiting) | Study of Amivantamab in Participants With Advanced or Metastatic Solid Tumors |
| 7 | BGB-LC-201
A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer |
Active (Recruiting) | Study of Tislelizumab in Combination With Investigational Agents |
| 8 | Jimmy 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) |
Active (Recruiting) | A Study to compare efficacy, safety, and immunogenicity of GME751 |
| 9 | INSIGHT-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 therapy |
Closed | Study to investigate tepotinib combined with osimertinib in MET amplified, advanced or metastatic non-small cell lung cancer (NSCLC) |
| 10 | LAURA
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. |
Closed | Study of osimertinib as maintenance therapy in patients with locally advanced |
| 11 | MARIPOSA
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. |
Closed | Study of JNJ-61186372 and Lazertinib Combination Therapy Versus Single Agent Osimertinib or Lazertinib as First-Line Treatment |
| 12 | ATORG003
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 mutation |
Closed | Study of Dacomitinib with or without dose titration for the first-line treatment of locally advanced |
| 13 | ML41262
A Prospective, Multicentre, Genomic Profiling Study In Patients With Locally Advanced Or Metastatic Non-small Cell Lung Cancer (NSCLC) In Malaysia Using Foundation Medicine |
Closed | |
| 14 | INCMGA 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 Participants |
Closed | Study of Platinum-based Chemotherapy with or without INCMGA00012 |
| 15 | PFIZER 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 review |
Closed | Real-world utilization and outcomes with “study drug” first-line treatment |
| 16 | MK7684A-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 immunotherapy” |
Closed | Study to compare the efficacy and safety of MK-7684A or MK-7684A plus Docetaxel |
| 17 | MARIPOSA2
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 Failure |
Closed | A Study of Amivantamab and Lazertinib in Combination With Platinum-Based Chemotherapy |
| 18 | ADAURA-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 Resection |
Closed | Study to assess the Efficacy and Safety of Adjuvant Osimertinib |
| 19 | kontRASt-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 cancer |
Closed | A randomized, controlled, open label, phase III study evaluating the efficacy and safety of JDQ443 |
| No | Clinical Trial | Status | Clinical Trial Gov |
|---|---|---|---|
| 1 | MO42541
A phase III, open-label, randomized study of atezolizumab with lenvatinib or sorafenib versus lenvatinib or sorafenib alone in HCC previously treated with atezolizumab and bevacizumab |
Closed | Study of atezolizumab with lenvatinib or sorafenib |
| No | Clinical Trial | Status | Clinical Trial Gov |
|---|---|---|---|
| 1 | Origami-1
A Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy in Participants With Advanced or Metastatic Colorectal Cancer |
Closed | Study of Amivantamab Monotherapy and in Addition to Standard-of-Care Chemotherapy |
| 2 | MK4280A-007
A 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 Cancer |
Closed | Study of atezolizumab with lenvatinib or sorafenib |
| 3 | Krystal-10
A 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 Therapy |
Closed | Study of MRTX849 in Combination with Cetuximab |
| No | Clinical Trial | Status | Clinical Trial Gov |
|---|---|---|---|
| 1 | PRL3-Zumab
An Open Label, Multicenter, Safety and Efficacy Phase II/III Study of PRL3-Zumab in Solid Tumors Patients |
Active (Recruiting) | NA |
| No | Clinical Trial | Status | Clinical Trial Gov |
|---|---|---|---|
| 1 | GCT3014-01
An Open-Label, Multicenter, Phase 1/2 Study of GEN3014 (HexaBody®-CD38) in Relapsed or Refractory Multiple Myeloma and Other Hematologic Malignancies |
Closed | Study of GEN3014 (HexaBody®-CD38) |
| 2 | IMR Bortezomib
Genetic Variation Associated with Bortezomib Induced Peripheral Neuropathy in Adult Multiple Myeloma Patients (Investigator initiated study) |
Closed | NA |
Apart from oncology clinical trials, our consultants from other centres of excellence have also made substantial contributions to their clinical specialty with their published research. Below are the research publications (abstract, research papers, poster presentations, etc) produced by our consultants:
| No | Publication Title | Name of Consultant | Type of Presentation |
|---|---|---|---|
| 1 | Tepotinib 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 trial | Dr Tho Lye Mun (Consultant Clinical Oncologist) | Original Article |
| 2 | Effectiveness of adjunctive ultrasound after mammography in improving breast cancer screening findings from a study in Malaysian women | Mohamed Ibrahim Wahid, Nurul Alia Azmi, Pei Yun Tan, Bao Jing Chen, |
Original Article |
| 3 | Topical nonsteroidal anti‐inflammatory drugs for management of osteoarthritis pain: A consensus recommendation | Joon-Kiong Lee, Azlina A.Abbas, Tien-Eang Cheah, Ruslan Nazaruddin Simanjuntak, Sargunan Sockalingam, Sharifah Roohi |
Original Article |
| 4 | Retrospective Analysis of Clinical Outcomes of Stereotactic Body Radiation Therapy for Localized Prostate Cancer at an Asian Cancer Specialist Centre | Jasmin Loh Pei Yuin, Jessica Tan Jia Shin, Chen Bao Jing, Tho Lye Mun, Manivanna Arkonam Balasubramaniam, Dato Mohamed Ibrahim Wahid |
Original Article |
| 5 | KASRP
Impact 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) |
|
| 6 | Presenting complaints of patients and palliative care referral patterns | Dr Felicia Chang Dr Azura Jessica Tan Jia Shin, Ph.D (Clinical Informatics Specialist) |
|
| 7 | Breast cancer survivorship in an Asian specialist centre from Malaysia: A retrospective analysis | Dato Ibrahim Dr Azura Arkonam Balasubramaniam Manivannan (Consultant Oncologists) Jessica Tan Jia Shin. Ph. D (Clinical Informatics Specialist) |
Original Article |
| 8 | Does A Picture Really Paint A Thousand Words? A Study On The Technical Qualities Of Online Aesthetic Oculofacial Clinical Photographs | Dr Ong Chin Tuan (Consultant Ophthalmologist) | Poster |
| 9 | Healthcare Performance Measurement And Reporting For Breast Cancer Services in Malaysia | ||
| 10 | Healthcare Performance Measurement And Reporting System (HPMRS) For Cancer Care |
If you are interested and want to know more about these ongoing trials, please contact us at +603-7787 2830 or you can drop us an email at clinicalresearch@beaconhospital.com.my.
Beacon Hospital Independent Ethics Committee is an independent body constituted of individuals who are professionally trained in the medical discipline, non-medical scientists, non-scientific members, and laypersons whose responsibility is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing a continuing review of the trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects. The BH-IEC operates in strict adherence to local and international ethics standards and undergoes regulatory inspection as per national guidelines. The clinical trials are conducted in accordance with the ethical principles that originate in the Declaration of Helsinki, and that are consistent with Good Clinical Practice (GCP) and the applicable regulatory requirement(s) of the country.
BHIEC is mandated to perform the following responsibilities:
*Forms templates are available from the secretary of BH-IEC
| Month | Meeting Date (subject to change) | Submission Date |
|---|---|---|
| December | 16 December | 2 December 2024 |
| Month | Meeting Date (subject to change) | Submission Date |
|---|---|---|
| January | 13 January 2025 | 30 December 2024 |
| Febuary | 10 February 2025 | 27 January 2025 |
| March | 10 March 2025 | 24 February 2025 |
| April | 14 April 2025 | 31 March 2025 |
| May | 12 May 2025 | 28 April 2025 |
| June | 16 June 2025 | 3 June 2025 |
| July | 14 July 2025 | 30 June 2025 |
| August | 11 August 2025 | 28 July 2025 |
| September | 15 September 2025 | 1 September 2025 |
| October | 13 October 2025 | 29 September 2025 |
| November | 10 November 2025 | 27 October 2025 |
| December | 15 December 2025 | 1 December 2025 |
Note
BH-IEC Secretariat
No.1 Jalan 215, Section 51, Off Jalan Templer, 46050 Petaling Jaya, Selangor
+603-7787 2830
secretariat.bhiec@beaconhospital.com.my
© 2024 Beacon Hospital (寶康医院). SDN. BHD. 200301019556 (621976-D) | (KKLIU 3340/2025)
