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

2255 5034

HKU

ARC-10

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

Kit CHEUNG

2255 5034

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

CGX1321-102

A Phase 1 Open-label Dose Escalation Study of CGX1321 in Subjects with Advanced Gastrointestinal Tumors

Gastrointestinal tumor

CGX1321

Histologically-diagnosed advanced GI tumors with confirmed genetic alterations (e.g., Rspo2 fusion, Rspo3 fusion or predicted loss-of-function mutations in RNF43) upstream in the WNT pathway and no predicted change-of-function alterations in genes (e.g., APC, CTNNB1 and Axin1) downstream in the WNT pathway, that have relapsed or are refractory to or are not considered medically suitable to receive standard of care treatment

Dr LAM Ka On

Joyce FAN /

Peony LAU

2255 4216

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

Kit CHEUNG

2255 5034

HKU+QMH

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

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

A: Gevokizumab + Bev + FOLFOX 6
B: Gevokizumab + Bev + FOLFIRI

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

**for further details please contact PI / SC as the criteria is complex with different sub-cohorts**

Dr LAM Ka On

Joyce FAN /

Peony LAU

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 + 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

Kit CHEUNG

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-3475-859

A Phase 3, randomized, double-blind clinical study of pembrolizumab (MK-3475) plus chemotherapy versus palcebo plus chemotherapy as first-line treatment in participants with HER2 negative, previously untreated, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma (KEYNOTE-859)

Stomach / GEJ Cancer

Pembrolizumab + Xelox

vs

Placebo + Xelox

1st line treatment for inoperable, advanced or metastatic GC or GEJ carcinoma, Her2 -ve

Dr LAM Ka On

Joyce FAN /

Peony LAU

2255 4216

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

RAIN-701

A Phase 2 Study to Evaluate the Clinical Activity of Tarloxotinib in Patients with Non-Small Cell Lung Cancer that Harbors Either an EGFR Exon 20 Insertion or a HER2-Activating Mutation and Other Advanced Solid Tumors with NRG1/ERBB Family Gene Fusions

Cohort B: HER2-activating mutation

Cohort C: NRG1 or ERBB/HER-family gene fusions

Tarloxotinib

1. Stage IV, III B or III C NSCLC or recurrent disease with progression / platinum-based chemotherapy OR locally advanced or metastatic solid tumor with progression after SOC
2. CLIA diagnosis of eligible cancer mutation or fusion
  • Cohort B: HER2-activating mutation
  • Cohort C: NRG1 or ERBB/HER-family gene fusions
3. QTcF <450 msec. Patient must not have medication that prolongs QT interval or history of Long QT Syndrome

Dr Victor LEE

Annie WONG

2255 5362

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 + 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

Oscar LEUNG /

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

Joyce FAN /

Peony LAU

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

Joyce FAN /

Peony LAU

2255 4216