MoST therapeutic studies

MoST 4 substudy 9: Vismodegib

Title: Single arm, open label, signal seeking, phase IIa trial of the activity of vismodegib in patients with tumours harbouring PTCH1 or SMO mutations

The aim of this MoST substudy is to assess the clinical value of Hedgehog pathway inhibition in patients with advanced cancers harbouring mutations in PTCH1 or SMO.

Eligible Population: Participants will be enrolled in the MoST program for molecular screening and eligible for this study if a germline or somatic mutation in PTCH1 or SMO is identified in their tumour. Those with tumours harbouring SUFU mutations or particular mutations in SMO known to affect vismodegib binding (ie. SMO G497W, SMO D473Y) are excluded.

Substudy status: recruiting

ANZCTR registration number: ACTRN12618000281291

ANZCTR registration details

MoST 5 substudy 10: Eribulin

Title: Single arm, open label, signal seeking, phase IIa trial of the activity of eribulin in patients with advanced CD31 positive angiosarcoma and selected CD31 positive sarcomas.

The aim of this MoST substudy is to assess the activity of eribulin in a population of patients with metastatic or unresectable angiosarcoma and other selected CD31 positive sarcomas.

Eligible Population: Patients with metastatic or unresectable CD31+ angiosarcoma or other selected CD31+ sarcomas including malignant and progressive epithelioid hemangioendothelioma (2:1 in favour of angiosarcoma or other selected CD31+ sarcomas, including epithelioid hemangio-endothelioma (EHE)))

Substudy status: recruiting

ANZCTR registration number: ACTRN12618000357257

ANZCTR registration details

MoST 6 substudies 14-15: Larotrectinib

Title: Single arm, open label, signal seeking, phase IIa trial of the activity of larotrectinib in patients with advanced NTRK1-3 positive tumours.

The aim of this MoST substudy is to assess the clinical activity of larotrectinib in a population of patients with advanced tumours harbouring NTRK1-3 rearrangments in (i) primary central nervous system (CNS) tumours and (ii) non-CNS cancers.

Eligible Population: Participants will be enrolled in the MoST program for molecular screening and be eligible for this substudy if a somatic NTRK1-3 rearrangment is identified in their tumour.

Substudy status: recruiting

ANZCTR registration number: ACTRN12619001147178

ANZCTR registration details

MoST 7 substudies 16-18: Tremelimumab

Title:  Single arm, open label, signal seeking, phase II trial of Tremelimumab in patients with tumours with advanced rare or neglected cancers

The aim of this MoST substudy is to assess the clinical activity of of tremelimumab in a population of patients with advanced cancer and rare or neglected disease grouped post-hoc on the basis of tumour mutational burden (TMB) score/status.

Eligible Population: Participants will be enrolled in the MoST program for molecular screening and be eligible for this substudy on the basis of high or medium ordinally ranked tumour mutational burden (TMB) score/status.

Substudy status: recruiting

ANZCTR registration number: ACTRN12620000918921

ANZCTR registration details

MoST 8 substudies 19-20: TDM1 (Kadcyla)

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.

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 amplfication. Breast and gastric cancers will not be eligible for group 2.

Group 1: activating HER2 mutation; Group 2: HER2 amplification in the absence of a HER2 mutation

Substudy status: recruiting

ANZCTR registration number: ACTRN12619001265167

ANZCTR registration details

MoST 9 substudies 21-22: Tucatinib plus Trastuzumab

Title: Single arm, open label, signal seeking, phase II trial of the activity of tucatinib plus trastuzumab in patients with tumours harbouring HER2 amplifications or mutations

The aim of these MoST substudies is to assess the clinical activity of tucatinib in combination with trastuzumab in a population of patients with advanced tumours harbouring HER2 amplification or mutations.

Eligible Population: Adult patients with tumours expressing HER2, if a somatic HER2 amplification or mutation is identified in their tumour, their primary cancer is not breast or gastric cancer (for the HER2 amplified group) and they have not received any previous HER2 directed therapy.

Substudy status: in start up

ANZCTR registration number: ACTRN12620000767909 (provisional)

ANZCTR registration details

MoST 10 substudies 23-24: Palbociclib and Avelumab

Title: Single arm, open label, signal seeking, phase II trial of the activity of Palbociclib in combination with Avelumab in patients with tumours with amplified D-type cyclins or CDK4/6 or inactivation of CDKN2A

The aim of these MoST substudies is to assess the clinical activity of combination of palbociclib and avelumab after initial priming with palbociclib in patients with advanced cancer with eligible mutations of the following:

  1. Gain-of function mutations in CDK4 and CCND1-3
  2. CDKN2A deletion or loss-of-function mutations

Eligible Population: Adults with tumours expressing amplified D-type cyclins or CDK4/6 or inactivation of CDKN2A. Group 1: Gain-of-function mutation in CDK4 and CCND1-3 OR Group 2: CDKN2A deletion or loss-of-function mutations

Substudy status: in start up

ANZCTR registration number: ACTRN12620000568910p (provisional)

ANZCTR registration details

MoST 11 substudies 25-26: Tildrakizumab

Title: Single arm, open label signal seeking, phase II trial to study the clinical activity of Tildrakizumab in patients with advanced osteosarcoma and soft tissue sarcomas.

The aim of these MoST substudies is to assess the clinical activity of tildrakizumab in patients with advanced osteosarcomas or soft tissue sarcomas.

Eligible Population: Treatment-refractory advanced osteosarcoma and other sarcomas.

Substudy status: recruiting

ANZCTR registration number: ACTRN12620000984998

ANZCTR registration details

MoST 12 substudies 27-30: Vemurafenib and Cobimetinib

Title: Single arm, open label, phase II trial of vemurafenib and cobimetinib in patients with metastatic non-squamous non-small cell lung cancer and other tumours harbouring BRAF V600 mutations detected by comprehensive genomic profiling.

The aim of this ASPiRATION and MoST substudy is to assess the clinical activity of combination of vemurafenib and cobimetinib in patients with newly diagnosed metastatic non-squamous small cell lung cancer (NSCLC) or other tumours harbouring BRAF V600 mutations.

Eligible Population: Adult patients with pathologically confirmed metastatic non-squamous NSCLC or other advanced cancers harbouring a BRAF V600 mutation.

Substudy status: in start up

ANZCTR registration number: ACTRN12620000984998

ANZCTR registration details

MoST 13 substudy 31: Entrectinib

Title: A single-arm, open-label, phase II trial of entrectinib in patients with advanced tumours harbouring NTRK fusions or ROS1 gene rearrangements detected by comprehensive genomic profiling.

The aim of this ASPiRATION and MoST substudy to assess the clinical activity of entrectinib in adult patients with advanced cancers harbouring NTRK or ROS1 gene alterations.

Eligible Population: Adult patients with advanced cancers harbouring NTRK fusions or ROS1 gene rearrangements. NSCLC patients with ROS1 gene alterations must be FISH-negative, i.e. not eligible for reimbursed ROS1-targeted treatment.

Substudy status: in start up

ANZCTR registration number: TBC

MoST 14 substudy 32: Alectinib

Title: A Single arm, open label, phase II trial of alectinib in patients with advanced tumours harbouring ALK gene alterations detected by comprehensive genomic profiling.

The aim of this ASPiRATION and MoST substudy to assess the clinical activity of of alectinib in adult patients with advanced cancers harbouring an ALK gene alteration.

Eligible Population: Adult patients with advanced cancers harbouring ALK gene alterations identified using CGP. NSCLC patients with ALK gene alterations must be FISH-negative, i.e. not eligible for reimbursed ALK-targeted treatment.

Substudy status: in start up

ANZCTR registration number: TBC

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