Stuart Roberts - Projects - Monash University

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EmailStuart.Robertsmonashedu

Research activity per year

3 Not started
15 Finished
21 Active

39 results

Active

A Phase 1, Open-Label, First-in-Human, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of MT 303 in Adults with Advanced or Metastatic GPC3-Expressing Cancers, including Hepatocellular Carcinoma
Roberts, S.
25/09/24 → 24/09/26
Project: Research
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING THE SAFETY AND EFFICACY OF EFRUXIFERMIN IN SUBJECTS WITH COMPENSATED CIRRHOSIS DUE TO NONALCOHOLIC STEATOHEPATITIS (NASH)/METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS (MASH)
Roberts, S.
18/09/24 → 17/09/26
Project: Research
A Phase 1 Randomised, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of INI-822 in Healthy Volunteers and Participants with Non-Alcoholic Steatohepatitis (NASH) Or Presumed NASH
Roberts, S. & Mitchell, J.
27/08/24 → 26/08/26
Project: Research
A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Cavrotolimod Alone and in Combinations in Subjects with Chronic Hepatitis B Infection
Roberts, S.
17/08/24 → 17/08/26
Project: Research
A Long-Term Follow-up Study for Subjects with Chronic Hepatitis B Previously Treated with Imdusiran (AB-729)
Roberts, S.
22/05/24 → 22/05/30
Project: Research
A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase IIb Study to Evaluate the Safety of Zibotentan/Dapagliflozin in Combination Compared to Zibotentan Monotherapy as well as Zibotentan/Dapagliflozin and Zibotentan Monotherapy Compared to Placebo in Participants with Cirrhosis
Roberts, S. & Lewis, P.
2/04/24 → 1/04/26
Project: Research
A Phase 3, Randomised, Double-Blind, Placebo-Controlled Study Evaluating the Safety and efficacy of Efruxifermin in subjects with Non-Cirrhotic Non-alcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
Roberts, S.
1/02/24 → 2/02/26
Project: Research
An Open-label Study Evaluating the Safety, Antiviral Activity, and Pharmacokinetics of IMC-I109V in HLA-A*02:01 Positive Patients with Chronic HBV who are Non-Cirrhotic, Hepatitis B e Antigen-negative, and Virally Suppressed
Roberts, S. & Mitchell, J. L.
12/01/24 → 11/01/26
Project: Research
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Efruxifermin in Subjects with Non-Invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Roberts, S.
17/11/23 → 17/11/25
Project: Research
An Open-Label Phase 1b Study Evaluating the Safety, Tolerability, Immunogenicity and Antiviral Activity of Multiple Doses of CLB-3000 in Subjects with Chronic Hepatitis B
Roberts, S. & McKenzie, J.
2/08/23 → 1/08/25
Project: Research
ASSURE: An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)
Roberts, S.
11/10/22 → 10/10/27
Project: Research
A Phase IIb/III Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Cotadutide in Participants with Noncirrhotic Non-alcoholic Steatohepatitis with Fibrosis (PROXYMO-ADVANCE)
Roberts, S.
1/06/22 → 31/08/27
Project: Research
TRANSFORM: A 52-week, Randomized, Placebo-controlled, Double-blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52-week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness.
Roberts, S.
26/02/22 → 1/01/26
Project: Research
A Phase 2a, Randomized, Blinded, Multicenter Study Investigating a Combination of AB-729 and VTP-300 in Virologically-Suppressed Chronic Hepatitis B Participants.
Roberts, S.
1/02/22 → 31/12/24
Project: Research
Efficacy and safety investigation of NNC0194-0499 co-administered with semaglutide in subjects with non-alcoholic steatohepatitis: a dose-ranging, placebo-controlled trial
Roberts, S.
9/09/21 → 31/12/24
Project: Research
RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)
Roberts, S.
16/07/21 → 31/12/24
Project: Research
A Multicentre, Observational, Phase 4 Study to Evaluate the Safety and Tolerability of Lenvatinib in Patients with Advanced or Unresectable Hepatocellular Carcinoma (STELLAR)
Roberts, S. & Lewis, P.
28/05/21 → 31/12/27
Project: Research
A Double-Blinded, randomized, Parallel-Group, PHASE 2 Study to investigate the Effect of RO7049665 on the time to relapse following steroid tapering in patients with Autoimmune Hepatitis
Roberts, S. & Jones, A.
1/03/21 → 31/12/24
Project: Research
A Phase 2, Randomized, Double-blinded, Placebo-controlled, Multicenter, Dose-finding Study to Evaluate the Efficacy and Safety of CC-90001 in Subjects with Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
Roberts, S.
19/12/19 → 31/12/24
Project: Research
RECIPE: Randomised controlled trial (RCT) of ROTEM-guided blood component administration versus standard of care in patients with cirrhosis and coagulopathy undergoing invasive procedures.
Majeed, A., Janko, N. E., Roberts, S., Kemp, W., Nandurkar, H. & Gow, P. J.
5/12/19 → 20/12/24
Project: Research
A Phase 3, Multinational, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 (resmetirom) in Patients with Non-Alcoholic Steatohepatitis (NASH) and Fibrosis to Resolve NASH and Reduce Progression to Cirrhosis and/or Hepatic Decompensation. Clinical study No. MGL-3196-11.
Roberts, S.
24/10/19 → 31/12/24
Project: Research
Not started

Discovery and validation of biomarkers for nonalcoholic steatohepatitis and liver fibrosis
Watt, M., Montgomery, M., Burton, P., Brown, W., Roberts, S., Kemp, W. & Earnest, A.
Project: Research
A Phase 1/2a - Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BJT-778 in Healthy Volunteers and in Subjects With Chronic Hepatitis B Infection, Including Subjects With Chronic Hepatitis D Infection
Roberts, S.
Project: Research
A Randomized Phase 2 Trial of Atezolizumab and Bevacizumab in Combination With SRF388 or Placebo in Patients With Untreated Locally Advanced or Metastatic Hepatocellular Carcinoma.
Roberts, S., Lewis, P., Matos, M., Zekry, A. & Haridy, J.
Project: Research
Finished

A Randomized Phase 2a, Multicenter, Open-Label, Multiple-Cohort Study Evaluating Regimens Containing Vebicorvir in Subjects with Chronic Hepatitis B Virus Infection
Roberts, S., Matthews, G. V., Sasadeusz, J., Chen, F., Valaydon, Z. S., George, J., MacQuillan, G., Thompson, A. J. & Davison, S.
12/05/21 → 31/12/22
Project: Research
Randomized, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of EP547 in Healthy Subjects with Cholestatic or Uremic Pruritis.
Roberts, S. & Kerr, P.
1/12/20 → 31/12/22
Project: Research
A randomized, double-blind, dose-ranging, placebo-controlled, Phase 2a evaluation of the safety, tolerability, and pharmacokinetics of PLN 74809 in participants with primary sclerosing cholangitis (PSC) and suspected liver fibrosis (INTEGRIS-PSC).
Roberts, S., Adams, L. A., George, J., Strasser, S. I., Thompson, A. J. & Lynch, K. D.
1/10/20 → 1/11/23
Project: Research
A Phase 2a, Multicenter, Single-Blind, Placebo-Controlled, Multiple Cohort Study Evaluating ABI-H2158-Containing Regimens in Chronic Hepatitis B Infection.
Roberts, S. & Mitchell, J. L.
15/08/20 → 15/08/22
Project: Research
A Phase 3 Multicenter, Randomized, Double-blinded, Active-controlled, Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) with Pembrolizumab (MK-3475) in Combination with Transarterial Chemoembolization (TACE) Versus TACE in Participants with Incurable/Non-metastatic Hepatocellular Carcinoma (LEAP-012).
Roberts, S. & Lewis, P.
5/06/20 → 31/12/23
Project: Research
Evaluation of Efficacy, Safety and Tolerability of NGM282 (aldafermin) in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study in Subjects with Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (ALPINE4)
Roberts, S. & Jones, A.
14/02/20 → 31/12/22
Project: Research
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of Seladelpar Administered for 24 Weeks in Adult Patients with Primary Sclerosing Cholangitis (PSC)
Roberts, S.
22/11/19 → 31/12/21
Project: Research
A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) versus Placebo as Adjuvant Therapy in Participants with Hepatocellular Carcinoma and Complete Radiological Response after Surgical Resection or Local Ablation
Roberts, S. & Lewis, P.
8/11/19 → 30/06/23
Project: Research
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of Cilofexor in Non-Cirrhotic Subjects with Primary Sclerosing Cholangitis
Roberts, S. & Lewis, P.
30/10/19 → 31/12/21
Project: Research
A Randomized, Multi-center, Phase 3 Study of Nivolumab in Combination with Ipilimumab Compared to Sorafenib or Lenvatinib as First-Line Treatment in Participants with Advanced Hepatocellular Carcinoma.
Roberts, S., Lewis, P., George, J., Zekry, A., O’Beirne, J., Tse, E., McLachlan, S. A., Eastgate, M., Ananda, S. S. & Davison, S.
24/09/19 → 30/09/23
Project: Research
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GS-4224 in Healthy Volunteers and Subjects with the Chronic Hepatitis B (CHB) Virus
Roberts, S. & Jones, A.
19/06/19 → 31/05/21
Project: Research
A Phase 1 Study of the Safety, Tolerability, Pharmacokinetics, and Food Effect of Single and Multiple Doses of ABI-H2158 in Healthy Volunteers; and the Multiple-Ascending Dose Pharmacokinetics and Pharmacodynamics in Patients with Chronic Hepatitis B Infection.
Roberts, S. & Mitchell, J. L.
29/05/19 → 30/09/19
Project: Research
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 (EMERALD-2).
Roberts, S.
17/05/19 → 31/05/23
Project: Research
An Open-Label Study to Assess The Efficacy and Safety of LM011 In Subjects Diagnosed With Non-Alcoholic Steatohepatitis (NASH).
Roberts, S.
16/04/19 → 31/12/19
Project: Research
A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Transarterial Chemoembolization (TACE) in Combination with either Durvalumab Monotherapy or Durvalumab plus Bevacizumab Therapy in Patients with Locoregional Hepatocellular Carcinoma (EMERALD-1).
Roberts, S. & Lewis, P.
24/01/19 → 30/04/23
Project: Research