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

1. squamous cell NSCLC       

2. adenocarcinoma

3. NSCLC      cholangiocarcinoma           

4. HNSCC                                         

5. pancreatic                   

6. adenocarcinoma  solid tumor, exclusive of squamous or adenocarcinoma NSCLC, cholangiocarcinoma, HNSCC, pancreatic adenocarcinoma, primary brain tumor, and lymphoma

AMG 193 alone and in combination with docetaxel

1. Adults (>=18 years old) with advanced MTAP-null solid tumors                             

2. Histologically confirmed metastatic or locally advanced solid tumor not amenable to curative treatment with surgery and/or radiation                                                     

3. Disease measurable as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)                                                                                         

4. Tumor tissue sample must be available (either fresh or achieved)

Dr. Aya El Helali

Stephen AU (main)
2255 5034
Angela IU (backup)
2255 5124                 

HKU

61186372NSC3002

A Phase 3, Open-Label, Randomized Study of Amivantamab and Lazertinib in Combination with Platinum-Based Chemotherapy Compared with Platinum-Based Chemotherapy in Patients with EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer After Osimertinib Failure

Locally advanced/Metastatic NSCLC

Arm A: Lazertinib + Amivantamab + Carboplatin + Pemetrexed
Arm B: Carboplatin + Pemetrexed
Arm C: Amivantamab + Carboplatin + Pemetrexed

1. Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-squamous NSCLC, characterized at or after the time of locally advanced metastatic disease diagnosis by either EGFR Exon 19del or Exon 21 L858R mutation.
2. Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment. Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second-line setting after prior treatment with first- or second-generation EGFR TKI.

Dr. Victor LEE

Angela IU
2255 5124/
Cherry CHENG
2255 5034

HKU

AN2025H0301

The BURAN Study of Buparlisib (AN2025) In Combination with Paclitaxel Compared to Paclitaxel Alone, in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Buparlisib + Paclitaxel vs. Paclitaxel

1. Patient has histologically and/or cytologically-confirmed HNSCC.
2. Patient has either progressive or recurrent disease after treatment with PDL1/PD1 based therapy for recurrent or metastatic disease.
3. Patient has received no more than two prior lines of systemic treatment for recurrent or metastatic HNSCC.

Dr. Victor LEE

Angela IU
2255 5124/
Cherry CHENG
2255 5034

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

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

Stephen AU
2255 5034
          

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/
Michael WONG 2255 4216

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

Angela IU

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+ 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

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. 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 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 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

Stephen AU

2255 5034

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