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

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

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

Bryan Kwan
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 LAM Ka On

Michael WONG 2255 4216

HKU

Mermaid-2

A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Study of Durvalumab for the Treatment of Stage II-III NSCLC Patients With Minimal Residual Disease Following Surgery and Curative Intent Therapy

NSCLC

Durvalumab
vs
Placebo

Stage II-III NSCLC

Dr Victor LEE

Vera WONG

2255 5034

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

Bryan Yun
2255 5124

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

*investigator's choice of chemotherapy with FP IV or TP IV

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

Bryan Yun
2255 5124

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 Chan Wing Lok Wendy

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

Bryan Kwan
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/ Nate CHAN
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

Talazoparib + carboplatin

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 El Helali

Angela IU 2255 5124