HKU

ALTA-3

A Phase 3 Randomized Open-label Study of Brigatinib (Alunbrig®) Versus Alectinib (Alecensa®) in Advanced Anaplastic Lymphoma Kinase-Positive Non Small-Cell Lung Cancer Patients Who Have Progressed on Crizotinib (Xalkori®)

NSCLC

(ALK-positive)

Brigatinib

vs

Alectinib

1. ALK-positive NSCLC
2. Had been on Crizotinib for at least 4 weeks before progression
3. No more than 2 prior regimens of systemic anticancer therapy in the locally advanced or metastatic setting

Dr Victor LEE

Mike LAW

2255 5124

HKU

CACZ885T2301

A phase III, multicenter, randomized, double bliknd, placebo controlled study evaluating the efficacy and safety of canakinumab versus placebo as adjuvant therapy in adult subjects with stages AJCC/UICC v.8 II-IIIA and IIIB (T>5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC)

II-IIIA and IIIB (T>5cm N2) completely resected NSCLC

Canakinumab

vs

Placebo

Completely resected stage IIA-IIIB NSCLC who received  cisplatin-based chemotherapy and no radiation therapy

Dr Victor LEE

Mike LAW

2255 5124

HKU

Cullinan-Pearl

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

NSCLC

(Exon 20 mutated)

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

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

Cohort A: Metastatic colorectal carcinoma (1^st line)

Cohort B: Metastatic colorectal carcinoma (2^nd line)

Cohort C: Metastatic gastroesophageal carcinoma (2^nd line)

Cohort A: Gevokizumab +Bevacizumab + Modified FOLFOX6

Cohort B: Gevokizumab +Bevacizumab + FOLFIRI

Cohort C: Gevokizumab + Ramucirumab + Paclitaxel

Cohort A: Treatment-naive metastatic colorectal carcinoma 

Cohort B: Metastatic colorectal carcinoma after progression on prior first line treatment

Cohort C: Metastatic gastroesophageal carcinoma after progression on prior first line treatment

Dr LAM Ka On

Ka-kei CHEUNG / Michael WONG

2255 421

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

Bryce TANG

2255 4216

HKU + QMH

EF24

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

NSCLC

TT fields

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)

A. Durvaumab + Bevacizumab

B. Durvaumab + Bevacizumab placebo

C. 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 5123

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

Bryce TANG

2255 4216

HKU

MK-7902-015

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)

Gastric, GEJ, or esophageal adenocarcinoma (1^st line)

 Lenvatinib + Pembrolizumab + CAPOX/mFOLFOX6 vs CAPOX/mFOLFOX6

1. Previously untreated, locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma;

2. HER-2 negative

Dr LAM Ka On

Ka-kei CHEUNG / Michael WONG

2255 4216

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. Tumour size 5-15 cm and number of lesions ≤3
2. No prior systemic therapy nor immunotherapy
3. No prior TACE nor radiotherapy to liver or SIRT

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

Dr CHIANG Chi Leung

Yuuki TAM

2255 5125

HKU + QMH

XL184311

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Cabozantinib (XL184) in Subjects With Radioiodine-Refractory Differentiated Thyroid Cancer Who Have Progressed After Prior VEGFR-Targeted Therapy

Thyroid Cancer

Cabozantinib (XL 184)

vs

Placebo

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 Wendy CHAN

Tricia HO

2255 4216

HKU

YO42138

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Atezolizumab Plus Tiragolumab in Combination With Paclitaxel and Cisplatin Compared With Paclitaxel and Cisplatin as First-Line Treatment in Patients With Unresectable Locally Advanced, Unresectable Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma

Esophageal Carcinoma

Ateolizumab + Tiragolumab + Paclitaxel + Cisplatin

vs

Paclitaxel + Cisplatin

1. Patients With Unresectable Locally Advanced, Unresectable Recurrent, or Metastatic Esophageal Squamous Cell Carcinoma

Dr LAM Ka On

Ka-kei CHEUNG /

Michael WONG

2255 4216

HKU

ZL-2306-006

A Multicenter, Open-label, Single-arm, Phase Ib Dose Escalation and Expansion Clinical Study to Assess the Safety and Antitumor Activity of Niraparib in Combination with MGD013 in Patients with Advanced or Metastatic Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma (Collectively Referred to as Gastric Cancer) Who Failed Prior Treatment

Gastric/GEJ

(3rd line+)

Niraparib + MGD013

Gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who have previously failed at least 2 prior systemic treatment

Dr LAM Ka On

Ka-kei CHEUNG /

Michael WONG

2255 4216

HKU

ZL-8301-001

A Phase 2, Single Arm, Multi-center, Open-Label Trial to Evaluate the Safety and Efficacy of Treatment with Tumor Treating Fields (TTFields) and Chemotherapy as First-Line Treatment for Subjects with Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Gastric (GC) Adenocarcinoma

Gastric/GEJ

(1st line)

TT-Fields + Xelox

Histologically confirmed unresectable, locally advanced or metastatic Gastroesophageal Junction (GEJ) or Gastric (GC) Adenocarcinoma. The subject must be previously untreated with systemic treatment (including chemotherapy, targeted therapy, and Onco-Immunotherapy), and without resection of primary gastric focu

Dr LAM Ka On

Ka-kei CHEUNG /

Michael WONG

2255 4216