HKU

20210023                     

UW 22-014                   

CTC2265

A phase 1/1b/2 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AMG 193 alone and in combination with docetaxel in subjects with advanced MTAP-null solid tumors

• Squamous/ Adenocarcinoma NSCLC
• Biliary tract cancer (BTC)
• Head and neck squamous cell carcinoma (HNSCC)
• Pancreatic adenocarcinoma
• Solid tumor other than squamous/ adenocarcinoma NSCLC, BTC, HNSCC, pancreatic adenocarcinoma, primary brain tumor, and lymphoma.

• AMG 193
• Docetaxel

• Age ≥ 18 years. Evidence of homozygous loss of CDKN2A (null) (Parts 1a and 1b only) and/or MTAP (null) in the tumor tissue or blood (Parts 1a to 1h, Parts 2a and 2b) or lost MTAP expression in the tumor tissue (Parts 1a to 1h, Parts 2a and 2b)
• Histologically confirmed metastatic or locally advanced solid tumor not amenable to curative treatment with surgery and/or radiation.
• Able to swallow and retain PO administered study treatment and willing to record daily adherence to investigational product.
• Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).
• ECOG performance status of 0 to 1.

Dr. Aya El Helali

Kailyn HUI
2255 5034                 

HKU

ARC-10
CTC 2098HKU1
UW-21-081

A Phase 3 Study to Evaluate Zimberelimab (AB122) Combined with Domvanalimab (AB154) Conpared to Pembrolizumab in Front-Line, PD-L1-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Locally Advanced / Metastatic NSCLC

Zimberelimab (AB122) + Domvanalimab (AB154)
vs
Pembrolizumab

1. Histologically confirmed, treatment naïve, locally advanced or metastatic (Stage IIIB - IV), squamous or non-squamous NSCLC with documented high PD-L1 Expression
2. ECOG PS of 0-1                                         

Dr Victor LEE

Angela IU
2255 5124

HKU

DS1062-A-U303

A Randomized, Open-Label, Phase 3 Study to Evaluate Zimberelimab and Domvanalimab in Combination with Chemotherapy Versus Pembrolizumab with Chemotherapy for the First-Line Treatment of Patients With Metastatic Non–Small Cell Lung Cancer With No Epidermal Growth Factor Receptor or Anaplastic Lymphoma Kinase Genomic Tumor Aberrations

NSCLC

Arm A: Dao-DXd + Pembrolizumab + Carboplatin
Arm B: Dato-DXd + Pembrolizumab
Arm C: Pembrolizumab + Pemetrexed + Carboplatin

1) Stage IIIB or IIIC NSCLC who are not candidates for surgical resection or definitive chemoradiation, or Stage IV NSCLC
2) PD-L1 TPS < 50%
3) Negative test results for EGFR, ALK, ROS1, and other actionable driver kinases with locally approved therapies
4) Have not received prior systemic treatment for advanced or metastatic NSCLC

Dr. Victor LEE

Angela IU
2255 5124

HKU

DS1062-A-U304

A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects with Advanced or Metastatic PD-L1 High (TPS ≥50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (Tropion-Lung08)

NSCLC

Arm 1: Pembrolizumab + Dato-DXd
Arm 2: Pembrolizumab

1) Stage IIIB or IIIC NSCLC who are not candidates for surgical resection or definitive chemoradiation, or Stage IV NSCLC
2) High PD-L1 expression (TPS ≥ 50%)
3) Negative test results for EGFR, ALK, ROS1, and other actionable driver kinases with locally approved therapies
4) Have not received prior systemic treatment for advanced or metastatic NSCLC

Dr. Victor LEE

Angela IU
2255 5124

HKU

FOLFOXIRI and CRT for high risk rectal cancer                                 

UW 21-577

A randomized study of neoadjuvant chemoradiotherapy with or without intensification with the FOLFOXIRI chemo-regimen for high-risk locally advanced rectal cancer

Rectal adenocarcinoma

1. Arm A (control): Concurrent neoadjuvant concurrent capecitabine-radiotherapy followed by surgery and post-operative chemotherapy               

2. Arm B (experimental): Neoadjuvant FOLFOXIRI x 4 cycles then concurrent capecitabineradiotherapy, surgery and post-operative chemotherapy

1. Histologically confirmed rectal adenocarcinoma (defined as either mid- or low rectal cancer that is located within 12 cm from the anal verge OR below the peritoneal reflection) that is previously untreated.                                                                 

2. Measurable disease by RECIST 1.1 criteria.                                                                     

3. ‘High-risk’ rectal cancer, or rectal cancers that are considered marginally operable where there is a significant risk of ‘positive surgical margin’ (or otherwise known as ‘threatened circumferential margin’) = T3 or T4 tumor with one or more of the following features:
- Tumour infiltrating perirectal fat and/or mesorectal fascia and/or vasculature
- Pelvic lymph node involvement.
- Absence of distant metastases.

Dr. Aya El Helali

Kailyn HUI
2255 5034

HKU

GS-US-548-5916

A Phase 2 Study of Magrolimab Combination Therapy in Patients With Head and Neck Squamous Cell Carcinoma

Head and Neck Squamous Cell Carcinoma

magrolimab + pembrolizumab + platinum + 5-FU (Arm A) 
pembrolizumab + platinum + 5-FU (Arm B)
magrolimab + zimberelimab + platinum + 5-FU (delayed open Arm C)

1) Measurable disease according to RECIST, Version 1.1.
2) ECOG performance status of ≤ 1
3) histologically or cytologically confirmed metastatic or locally recurrent HNSCC that is considered incurable by local therapies
4) should not have had prior systemic therapy administered in the recurrent or metastatic setting. Systemic therapy that was completed more than 6 months prior to signing consent if given as part of multimodal treatment for locally advanced disease is allowed

Prof. Dora KWONG

Alex MAK
2255 4216

HKU

GS-US-626-6216

A Randomized, Open-Label, Phase 3 Study to Evaluate Zimberelimab and Domvanalimab in Combination with Chemotherapy Versus Pembrolizumab with Chemotherapy for the First-Line Treatment of Patients With Metastatic Non–Small Cell Lung Cancer With No Epidermal Growth Factor Receptor or Anaplastic Lymphoma Kinase Genomic Tumor Aberrations

NSCLC

Group A: Zimberelimab + Domvanalimab + Chemotherapy
Group B: Pembrolizumab + Chemotherapy
Group C: Zimberelimab + Chemotherapy

1) Pathologically documented stage IV NSCLC
2) EGFR and ALK negative
3) Have no known actionable genomic alterations with approved therapies
4) Have not received prior systemic treatment for metastatic NSCLC

Dr. Victor LEE

Angela IU
2255 5124

HKU

VT3996-301

An Open-Label, Multicenter Phase 1b/2 Study of Nanatinostat and Valganciclovir in Patients with Advanced Epstein-Barr Virus-Positive (EBV+) Solid Tumors and in Combination with Pembrolizumab in Patients with Recurrent/Metastatic Nasopharyngeal Carcinoma

Recurrent/Metastatic Nasopharyngeal Carcinoma

Nanatinostat + Valganciclovir

1. Histologically or cytologically documented EBV+ tumor cells by EBER-ISH or LMP-1 per an archival tumor sample taken within 2 years prior to screening, otherwise a de novo biopsy is required.
2. Patients with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) (excluding patients in the Phase 1b exploratory proof-of-concept cohort) for whom no potentially curative options are available, who have received at least 1 prior line of platinum-based chemotherapy and no more than 3 prior lines of therapy.

Dr. Victor LEE

Angela IU
2255 5124

HKU

Cullinan-Pearl
CTC 1927
UW19-570

A Phase 1/2a, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients With Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations

**Recrutment depends on whether cohort slots are available**

NSCLC
(Exon 20)

CLN-081

1. Documented EGFR exon 20 insertion mutation demonstrated by a test routinely used by each institution and performed in a CLIA-certified or equivalent laboratory.
2. Prior treatment in the recurrent/metastatic disease setting including:
- A platinum-based chemotherapy regimen (or other chemotherapy regimen if platinum-based chemotherapy is contra-indicated)
- Any other approved standard therapy that is available to the patient, unless this therapy is contraindicated, intolerable to the patient, or is declined by the patient. In the case of a patient declining such therapy, documentation that the patient has been informed and declined should be documented in the medical record.

Dr Victor LEE

Mike LAW
2255 5124

HKU

DS8201-A-U305
UW 21-061

A Phase 3, Multicenter, Randomized, Open-Label, 
Active-Controlled Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in Subjects with High-Risk HER2-Positive Primary Breast Cancer Who Have Residual Invasive Disease in Breast or Axillary Lymph Nodes Following Neoadjuvant Therapy

HER2+ Breast Cancer

Trastuzumab deruxtecan (T-DXd)
vs. 
Trastuzumab ematansine (T-DM1)

1. Pathologically documented HER2-positive breast cancer (BC)
2. Completion of neoadjuvant systemic chemotherapy, including taxane and HER2-directed treatment prior to surgery

3. Pathologic evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of neoadjuvant therapy meeting one of the following high-risk criteria:
- Inoperable breast cancer at presentation (prior to neoadjuvant therapy), defined as clinical stages T4, N0-3, M0 or T1-3, N2-3, M0
- Operable at presentation, defined as clinical stages T1-3,N0-1,M0, with axillary node positive disease (ypN1-3) following neoadjuvant therapy

Dr Wendy CHAN

Emina CHEUNG
2255 5124

HKU

DS8201-A-U306
UW21-362

A Phase 3, multicenter, 2-arm randomized, open-label study of trastuzumab deruxtecan in subjects with HER2-positive metastatic and/or unresectable gastric or gastro-esophageal junction (GEJ) adenocarcinoma subjects who have progressed on or after a trastuzumab-containing regimen (DESTINY-Gastric04)

Gastric/GEJ (2nd line)

Trastuzumab deruxtecan vs
Ramucirumab + paclitaxel

1. Progression on or after first-line therapy with a trastuzumab or approved trastuzumab biosimilar-containing regimen
2. Her-2 positive

Dr Wendy Chan

Michael WONG 2255 4216

HKU

A multi-centre phase II randomized-controlled study on addition of durvalumab (MEDI4736) to induction chemotherapy and concurrent chemoradiation and followed by maintenance durvalumab for locoregionally advanced nasopharyngeal carcinoma

NPC

Durvalumab

1. Previously untreated stage III-IVA nasopharyngeal carcinoma
2. All eligible patients must be magnetic resonance imaging of T1, T2 and T1-contrast enhanced sequences of the head and neck region and PET-CT scan within 60 days of study entry

Dr Victor LEE

Mike LAW

2255 5124

HKU

A multi-centre single-arm phase II study on durvalumab (MEDI 4736) with stereotactic body radiation therapy (SBRT) in patients with inoperable/unresectable hepatocellular carcinoma

inoperable / unresectable hepatocellular carcinoma

Durvalumab with SBRT

1. Histologically or radiologically confirmed HCC 
2. Inoperable or unresectable non-metastatic HCC amenable to stereotactic body radiation therapy given in 5 fractions

Dr Victor LEE

Mike LAW

2255 5124

HKU

MK-3475-975

A Randomized, Double-blind, Placebo-controlled Phase 3 Trial of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Receiving Concurrent Definitive Chemoradiotherapy (KEYNOTE 975)

Esophageal Carcinoma

Pembrolizumab + Chemoradiotherapy
vs
Placebo + Chemoradiotherapy

1. Histologically or cytologically confirmed diagnosis of cTX N+ M0 or cT2-T4a NX M0 Esophagus Squamous Cell Cancer with supraclavicular lymph node metastases only
2. ECOG of 0 or 1

Prof Dora KWONG

Alex MAK
2255 4216

HKU

MK7902-014

A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) + Lenvatinib (E7080/MK-7902) + Chemotherapy Compared With Standard of Care as First-line Intervention in Participants With Metastatic Esophageal Carcinoma

Metastatic Esophageal Carcinoma

Pembrolizumab + Lenvatinib + Chemotherapy vs Pembrolizumab + Chemotherapy

1. Metastatic squamous cell carcinoma of the esophagus
2. No GI obstruction, poor oral intake, difficulty in taking oral medication, or existing esophageal stent
3. No known history of Hepatitis B or active Hepatitis C virus infection

Professor Dora KWONG

Alex MAK
2255 4216

hku

GS-US-592-6238
UW 23-187

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Previously Untreated, Locally Advanced, Inoperable or Metastatic Triple-Negative Breast Cancer Whose Tumors Do Not Express PD-L1 or in Patients Previously Treated with Anti-PD-(L)1 Agents in the Early Setting Whose Tumors Do Express PD-L1

Triple-Negative Breast Cancer

Sacituzumab Govitecan
vs. 
Control Arm

1. Triple negative: ER(-), PR (-), HER2(-)
2. Inoperable, locally metastatic TNBC 
3. Previously untreated PD-L1 Negative. OR PD-L1 Positive in patients previously treated with an anti-PD-L1 agent in the curative setting.
4. ≥ 6 months since treatment in curative setting. 

Dr Wendy CHAN

Bryan Yuan
2255 5124

hku

OBI-822-011
UW18-484

The GLORIA Study: A Phase 3, Randomized, Open-Label Study of the 
Anti-Globo H Vaccine Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients with High-Risk, Early-Stage Globo H-Positive Triple Negative Breast Cancer

TNBC

Adagloxad Simolenin + OBI-821
vs. 
SOC

- Histologically documented TNBC (ER/PR ≤5% cells)

- High risk defined as:
 ≥1 cm residual primary or ≥1 residual axillary node after neoadjuvant chemotherapy 
OR
Pathological Stage IIB or III disease treated with adjuvant chemotherapy alone

- Received ≥4 cycles of standard taxane- and/or anthracycline-based chemotherapy

Dr Wendy CHAN

Bryan Yuan
2255 5124

HKU

TAS-102

Phase II Trial of TAS-102 in Patients with Advanced, Refractory Pancreatic Adenocarcinoma

Pancreatic Cancer

TAS-102

1. Histological or cytological confirmed advanced or metastatic pancreatic cancer 
2. Measurable disease according to the RECIST criteria (version 1.1) for the evaluation of 
measurable disease 
3. Documented progression after one or more lines of systemic chemotherapy 
a. For the treatment of advanced or metastatic disease 
b. Within 6 months after completion of neo-adjuvant therapy or adjuvant therapy 
4. Age ≥ 18 years 
5. Eastern Cooperative Oncology Group (ECOG) performance 0-1 
6. Written informed consent obtained for clinical trial participation and providing archival 
tumor tissue, if available 
7. Females of childbearing potential or non-sterilized male who are sexually active must use 
a highly effective method of contraception 
8. Females of childbearing potential must have negative serum or urine pregnancy test 
9. Have life expectancy ≥ 3 months 
10. Adequate organ function as defined as: 

Dr CHIANG Chi Leung

Isabel CHAN
2255 5362

HKU

UW 19-565

Tumor Control, Treatment Toxicity, Quality of Life and Bio-Imaging Repository Databank (TQ-BIRD) for Cancer Patients

All cancer types

Any kind of therapy or healthy control

1. Cancer Patients:

• 18 years of age and older.

• Scheduled to receive any kind of therapy or no cancer therapy

• ECOG Performance score of 0, 1, 2, or 3.

• Able to understand QoL questionnaire

2. Normal (non cancer) controls

• 18 years of age and older healthy volunteers. • Without a history of cancer except for cured skin cancer

• ECOG Performance status 0, 1, 2, or 3.

Professor Feng-ming Spring KONG

Eunice Xie 

22555123

HKU

OBI-822-011
UW18-484

The GLORIA Study: A Phase 3, Randomized, Open-Label Study of the 
Anti-Globo H Vaccine Adagloxad Simolenin (OBI-822)/OBI-821 in the Adjuvant Treatment of Patients with High-Risk, Early-Stage Globo H-Positive Triple Negative Breast Cancer

TNBC

Adagloxad Simolenin + OBI-821
vs. 
SOC

- Histologically documented TNBC (ER/PR ≤5% cells)


- High risk defined as:
 ≥1 cm residual primary or ≥1 residual axillary node after neoadjuvant chemotherapy 
OR
Pathological Stage IIB or III disease treated with adjuvant chemotherapy alone


- Received ≥4 cycles of standard taxane- and/or anthracycline-based chemotherapy

Dr Wendy CHAN

Bryan YUN
2255 5124

HKU

Cullinan-Pearl
CTC 1927
UW19-570

A Phase 1/2a, Open-Label, Multi-Center Trial to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of CLN-081 in Patients With Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations


**Recrutment depends on whether cohort slots are available**

NSCLC
(Exon 20)

CLN-081

1. Documented EGFR exon 20 insertion mutation demonstrated by a test routinely used by each institution and performed in a CLIA-certified or equivalent laboratory.
2. Prior treatment in the recurrent/metastatic disease setting including:
- A platinum-based chemotherapy regimen (or other chemotherapy regimen if platinum-based chemotherapy is contra-indicated)
- Any other approved standard therapy that is available to the patient, unless this therapy is contraindicated, intolerable to the patient, or is declined by the patient. In the case of a patient declining such therapy, documentation that the patient has been informed and declined should be documented in the medical record.

Dr Victor LEE

Cherry CHENG
2255 5034