HKU

ARC-10
CTC 2098HKU1
UW-21-081

A Phase 3 Study to Evaluate Zimberelimab (AB122) Monotherapy Compared to Standard Chemotherapy or Zimberelimab Combined with AB 154 in Front-Line, PD-L1-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Locally Advanced / Metastatic NSCLC

Zimberelimab (AB 122)
vs
Standard Chemotherapy / Zimberelimab + AB 154

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

Annie WONG
2255 5362/
Vera WONG
2255 5034

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

Vera WONG

2255 5034

HKU

CVPM087A2101
CTC1864
UW19-128

Phase Ib Study of Gevokizumab in Combination With Standard of Care Anti-cancer Therapies in Patients With Metastatic Colorectal Cancer, Gastroesophageal Cancer and Renal Cell Carcinoma

**Only open for cohort C**
**slot request needed before consent**

A: Colorectal (1st line)
B: Colorectal (2nd line)
C: Gastroesophageal (2nd line)
D: RCC (2nd / 3rd line)

A: Gevokizumab + Bev + FOLFOX 6
B: Gevokizumab + Bev + FOLFIRI
C: Gevokizumab + Ram + Pac
D: Gevokizumab + Cabozatinib

A: Colorectal (1st line)
B: Colorectal (2nd line)

**for further details please contact PI / SC as the criteria is com+E6+F6

Dr LAM Ka On

Ka-kei CHEUNG / Michael WONG

2255 4216

HKU

D933YC00001 (Pacific-5)

A Phase III, Randomised, Double-Blind, Placebo-Controlled Study of Durvalumab as Consolidation Therapy in Patients With Locally Advanced, Unresectable NSCLC, Who Have Not Progressed Following Definitive, Platinum-Based Chemoradiation Therapy

NSCLC

Durvalumab
vs
Placebo

1. Documented NSCLC and present with locally advanced, unresectable (Stage III) disease;
2. Receipt of concurrent or sequential chemoradiation therapy

Dr Victor LEE

Annie WONG

2255 5362

HKU

Debio 1143-SCCHN-301

A randomized, Double-Blind Placebo-Controlled, Phase 3 Study of Debio 1143 in Combination with Platinum-Based Chemotherapy and Standard Fractionation Intensity-Modulated Radiotherapy in Patients with Locally Advanced Squamous Cell Carcinoma of the Head and Neck, Suitable for Definitive Chemoradiotherapy (TrilynX)

SCC HN

Debio 1143

Inclusion Criteria:
1. Histologically confirmed diagnosis in previously untreated LA-SCCHN patient (stage III, IVA or IVB according to the American Joint Committee on Cancer [AJCC]/TNM Staging System, 8th Ed.) suitable for definitive CRT, of at least one of the following sites: oropharynx, hypopharynx and larynx.
2. Evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography scan or magnetic resonance imaging based on RECIST v 1.1.
3. For OPC patients, primary tumors must be HPV-negative as determined by p16 expression using immunohistochemistry (pathological report should be available).
4. Able to swallow liquids or has an adequately functioning feeding tube, gastrostomy or jejunostomy placed.
Exclusion Criteria:
1. Primary tumor of nasopharyngeal, paranasal sinuses, nasal or oral cavity, salivary, thyroid or parathyroid gland pathologies, skin or unknown primary site.
2. Metastatic disease (stage IVC as per AJCC/TNM, 8th Ed.).
3. Prior definitive or adjuvant RT and/or radical surgery to the head and neck region which may jeopardize the primary tumor irradiation plan, or any other prior SCCHN systemic treatment, including investigational agents.
4. Known history of infection with human immunodeficiency virus (HIV).
5. Known chronically active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
6. Non-compensated or symptomatic liver cirrhosis (Child-Pugh score: B or C).
7. History of another malignancy within the last 3 years prior to randomization, with the exception of completely resected non-melanoma cell skin cancer outside the head and neck area or completely resected stage I breast cancer, or completely resected in-situ non-muscular invasive bladder, cervix and/or uterine carcinomas.

Prof Dora Kwong

Cecilia TSE
2255 4216

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+ BC

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

Gobby Kwong/
Kelly Kwan
2255 5124

HKU + QMH

EF24
CTC2053
UW20-645

LUNAR: Pivotal, randomized, open-label study of Tumor Treating Fildes (TTFields) concurrent with standard of care therapies for treatment of Stage4 NSCLC following platinum failure
* Novocure GmbH

NSCLC

Device: NovoTTF-100L + Drug: Immune checkpoint inhibitors or docetaxel
vs
Drug: Immune checkpoint inhibitors or docetaxel

Stage 4 NsCLC following platinum failure

Dr Victor LEE

Vera WONG /

Annie WONG

2255 5034

HKU

EMERALD-2

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi Center Study of Durvalumab Monotherapy or in Combination With Bevacizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation

Hepatocellular carcinoma (HCC)

Durvaumab + Bevacizumab
vs
Durvaumab + Bevacizumab placebo
vs
Durvaumab placebo + Bevacizumab placebo

Inclusion Criteria:
1. Histologically or cytologically, newly diagnosed, confirmed HCC and successfully completed curative therapy (resection or ablation)
2. Imaging to confirm disease-free status within 28 days prior to randomization
3. Child-Pugh score of 5 or 6
Exclusion Criteria:
1. Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC
2. History of hepatic encephalopathy within 12 months prior to randomization
3.Patients with Vp1 to Vp4 portal vein thrombosis on baseline imaging are excluded
4.Active co-infection with both HBV and HCV, or co-infected with HBV and hepatitis D virus

Dr CHIANG Chi Leung

Yuuki TAM

2255 5125

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. Receiving concurrent definitive chemoradiotherapy

Prof Dora KWONG

Cecilia TSE
2255 4216

HKU

MK-7902-015
CTC2110
UW21-064

A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Lenvatinib (E7080/MK-7902) plus Pembrolizumab (MK-3475) plus Chemotherapy Compared with Standard of Care Therapy as First-line Intervention in Participants with Advanced/Metastatic Gastroesophageal Adenocarcinoma (LEAP-015)

advanced/metastatic gastroesophageal cancer 
(1st line)

Lenvatinib + CAPOX/mFOLFOX6 vs CAPOX/mFOLFOX6

1. Previously untreated, locally advanced unresectable / metastatic gastroesophageal adenocarcinoma
2. Her-2 negative

Dr LAM Ka On

Ka-kei CHEUNG / Michael WONG

2255 4216

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

Gobby Kwong/
Kelly Kwan
2255 5124

HKU

START-FIT double IO

Sequential TransArterial chemoembolization and stereotactic RadioTherapy Followed by Durvalumab (MEDI4736) and Tremelimumab for downstaging hepatocellular carcinoma for hepatectomy

Hepatocellular carcinoma (HCC)

TACE + SBRT + Durvalimab and Tremelimumab

1. Histologically or cytologically confirmed diagnosis of Differentiated Thyroid Cancer (DTC)
2. Previously treated with or deemed ineligible for treatment with Iodine- 131 for DTC
3. Previously treated with at least one of the following VEGFR-targeting TKI agents for DTC: lenvatinib or sorafenib. Note: Up to two prior VEGFR-targeting TKI agents are allowed

Dr CHIANG Chi Leung

Yuuki TAM

2255 5125

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

Yuuki TAM

2255 5125

HKU

TAC-GReD

Combination Talazoparib - carboplatin for recurrent high-grade glioma with DNA damage repair deficiency (DDRd) “TAC-GReD” trial

high-grade glioma

Recurrent GBM

Talazopairb + Carboplatin

1. Histopathologically proven diagnosis of WHO grade 3-4 glioma
2. Tumor with one or more putatively pathogenic mutations or homozygous deletion in the genes associated with DDR or genomic instability
3. The original histology was lower-grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma
4. Prior history of standard-dose CNS radiation of 50-60Gy in 25-30 fractions, or 40Gy in 15 Fractions
5. Recurrent high grade glioma with DDRd, defined by genomic aberrations associated including IDH mutation, PTEN mutation and “BRCAness” signature (ATM, ATR, BAP1, BRCA1, BRCA2, CDK12, CHEK1, CHEK2, FANCA, FANCC, FANCD2, FANCE, FANCF, PALB2, NGS1, WRN, RAD50, RAD51B, RAD51C, RAD51D, MRE11A, BLM, BRIP1)

Dr Aya Helali

Freda Chung

2255 5124