MoST Core Studies (C1)

These are the substudies developed under the MoST Framework protocol.

  • NHMRC Clinical Trials Centre | MoST 16 substudy 37: Pamiparib | Germline or somatic DNA repair pathway mutation (e.g. BRCA1/2, ATM, RAD1/2, PALB2), and/or BRCA mutational signature | Leukaemia

    Title: Single arm, open label, signal seeking, phase II trial of pamiparib in patients with relapsed/ refractory myeloid haematological malignancy with aberrant germline or somatic DNA repair pathway function

    The aim of this MoST-LLy substudy is to assess the clinical activity of pamiparib in patients with acute myeloid leukaemia (AML) or myelodysplastic syndrome (MDS) with germline or somatic DNA repair pathway mutation (e.g. BRCA1/2), and/or BRCA mutational signature.

    Eligible Population: 

    Adult patients with acute myeloid leukaemia or myelodysplastic syndrome who have no standard of care options or have failed these options and have enrolled in the MoST program and found to have germline or somatic DNA repair pathway mutation (e.g. BRCA1/2), and/or BRCA mutational signature.

    Substudy status: Recruiting

    Registration number: ACTRN12621001183875

  • NHMRC Clinical Trials Centre | MoST 8 substudies 19-20, 35-36: TDM1 (Kadcyla) | HER2 | Lung

    Title: Single arm, open label, signal seeking, phase IIa trial of the activity of Trastuzumab emtansine (T-DM1) in patients with tumours harbouring HER2 amplifications or mutations

    The aim of these MoST substudies is to assess the clinical value of HER2 inhibition using T-DM1 in advanced cancer patients with tumours with (i) HER2 mutations and (ii) HER2 amplification. Due to close to recruitment on 13 Dec 2024

    Eligible Population: 

    Participants will be enrolled in the MoST program for molecular screening and eligible for this study if their tumour demonstrates an activating HER2 mutation or HER2 amplification.

    • Group 1 (CLOSED): activating HER2 mutation;
    • Group 2 (CLOSED): HER2 amplification in the absence of a HER2 mutation - Breast and gastric cancers will not be eligible for group 2;
    • Group 3-4: Metastatic, non-squamous NSCLC with activating HER2 mutation with/without amplification- 2nd and subsequent line only

    Substudy status: Recruiting

    Registration number: ACTRN12619001265167

  • NHMRC Clinical Trials Centre | MoST 15 substudies 33-34: Durvalumab plus Acalabrutinib | No specific biomarker | Lymphoma

    Title: A single arm, open label, signal seeking, phase II trial of the activity of Durvalumab in combination with Acalabrutinib in patients with high-grade B cell lymphoma

    The aim of this MoST-LLy substudy is to assess the clinical activity of durvalumab and acalabrutinib in patients with high grade B cell lymphoma.

    Eligible Population: 

    Adult patients with pathologically confirmed high grade B cell lymphoma enrolled in the MoST program for molecular screening are eligible for this study.

    Substudy status: Recruiting

    Registration number: ACTRN12621000507886

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