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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04029922
Registration number
NCT04029922
Ethics application status
Date submitted
19/07/2019
Date registered
23/07/2019
Date last updated
18/06/2023
Titles & IDs
Public title
Study of MT-5111 in HER2-positive Solid Tumors
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Scientific title
A Phase 1 Open-label, Multicenter Dose Escalation and Expansion Study of MT-5111 in Subjects With Previously Treated Advanced HER2-positive Solid Tumors
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Secondary ID [1]
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MT-5111_001
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Universal Trial Number (UTN)
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Trial acronym
MT-5111
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
HER2-positive Solid Cancers
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - MT-5111 (experimental study drug)
Experimental: Part A- Dose Escalation - Part A- Dose Escalation in patients with previously treated advanced HER2-positive solid tumors.
The assigned dose level of MT-5111 will be given as an intravenous (IV) infusion over about 30 minutes on the same day every week (i.e., on day 1, day 8 and day 15 of each cycle).
Experimental: Part B- Dose Expansion - Part B - Dose Expansion in previously treated HER2-positive breast, GEA and other HER2-positive solid cancers
Part B will include 3 expansion groups: Group B1 (Breast Cancer) will begin enrolling while Part A is being conducted following the completion of Cohort 7 and Subsequent cohort of subjects in group B1 may enroll into higher doses that are tolerated in Part A. Group B2 (GEA) and Group B3 (Other HER-2 positive solid cancer groups) will begin enrollment after the MTD or RP2D is determined in Part A.
The assigned dose level of MT-5111 will be given as an intravenous (IV) infusion over about 30 minutes on the same day every week (i.e., on day 1, day 8 and day 15 of each cycle).
Treatment: Drugs: MT-5111 (experimental study drug)
Experimental treatment with MT-5111
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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To evaluate safety and determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D)
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Assessment method [1]
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Evaluation of safety of MT-5111 as measured by number of subjects with adverse events using Common Terminology Criteria for Adverse Events (CTCAE) v 5.0
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Timepoint [1]
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21 day cycle
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Primary outcome [2]
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To evaluate tolerability and determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D)
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Assessment method [2]
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Evaluation of tolerability of MT-5111 as measured by number of subjects with dose limiting toxicities (DLTs)
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Timepoint [2]
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21 day cycle
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Secondary outcome [1]
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PK as measured by concentrations of free MT-5111 (Maximum Plasma Concentration [Cmax])
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Assessment method [1]
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Evaluation of the pharmacokinetic profile of MT-5111
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Timepoint [1]
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Day 1, Day 8, and Day 15 in Each 21-Day cycle
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Secondary outcome [2]
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PK as measured by concentrations of free MT-5111 (Time to reach maximum concentration after drug administration [Tmax])
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Assessment method [2]
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Evaluation of the pharmacokinetic profile of MT-5111
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Timepoint [2]
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Day 1, Day 8, and Day 15 in Each 21-Day cycle
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Secondary outcome [3]
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PK as measured by concentrations of free MT-5111 (Area Under the Curve [AUC])
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Assessment method [3]
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Evaluation of the pharmacokinetic profile of MT-5111
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Timepoint [3]
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Day 1, Day 8, and Day 15 in Each 21-Day cycle
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Secondary outcome [4]
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To evaluate the tumor response to MT-5111
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Assessment method [4]
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Objective response rate (ORR) defined as the proportion of subjects with either a complete response or a partial response as determined by investigator assessment
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Timepoint [4]
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Screening, approximately every 6 weeks, at End of Treatment and 30 days after the last dose
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Secondary outcome [5]
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To evaluate the immunogenicity of MT-5111
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Assessment method [5]
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Immunogenicity as measured by MT-5111 (anti-drug antibody [ADA] titer)
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Timepoint [5]
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Screening (baseline), Day 1 of each 21 day cycle, at the End of Treatment and the Follow-up Visit
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Secondary outcome [6]
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To evaluate the immunogenicity of MT-5111
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Assessment method [6]
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Immunogenicity as measured by MT-5111 (neutralizing antibody [NAb])
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Timepoint [6]
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Screening (baseline), Day 1 of each 21 day cycle, at the End of Treatment and the Follow-up Visit
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Eligibility
Key inclusion criteria
1. Histologically confirmed, unresectable, locally advanced or metastatic solid cancers:
- Part A (Dose-Escalation): All HER2-positive solid cancers are eligible
- Part B (Dose-Expansion): Any type of HER2-positive solid cancer, including breast
cancer, and gastric or gastroesophageal adenocarcinomas (GEA).
2. HER2-positive in the latest tumor sample tested for HER2 (testing to be done on a
metastatic lesion in cases of metastatic cancers).
3. Relapsed or refractory to or intolerant of existing therapy(ies)
4. At least 1 measurable or evaluable lesion according to RECIST 1.1 (Subjects with
evaluable disease only may be included in the dose escalation phase)
5. ECOG performance score of = 1
6. Adequate Bone marrow function as determined by:
- Absolute neutrophil count (ANC) = 1,000/mm3
- Platelet count = 75,000 mm³ and
- Hemoglobin = 8.0 g/dL
- Red blood cell transfusion within 2 weeks of study treatment start is allowed if
hemoglobin levels remain stable
7. Kidney function:
- Creatinine clearance (CLcr) = 50 mL/min either measured or estimated using the
Cockcroft-Gault formula
8. Cardiac Function:
- Left ventricular ejection fraction (LVEF) = 55% on the echocardiogram (ECHO)
assessment (preferred), or multigated acquisition (MUGA) scan, and QTcF = 480 ms
for women and QTcF = 450 ms for men [average from three QTcF values on the
triplicate 12-lead electrocardiogram (ECG)] at baseline
9. Hepatic function:
- Total bilirubin = 1.5 x ULN, or = 3 x ULN for subjects with Gilbert's Syndrome
and
- AST = 3 x ULN (or = 5 x ULN if liver metastasis) and ALT = 3 x ULN (or = 5 x ULN
if liver metastasis)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. History or current evidence of another tumor that is histologically distinct from the
tumor under study
2. Current evidence of new or growing CNS metastases during screening
- Subjects with known CNS metastases will be eligible if they meet protocol
specified criteria
3. Evidence of CTCAE Grade >1 toxicity before the start of treatment, except for hair
loss and those Grade 2 toxicities listed as permitted in other eligibility criteria
4. History or evidence of significant cardiovascular disease
5. Current evidence of active, uncontrolled hepatitis B virus, hepatitis C virus, human
immunodeficiency virus (HIV) (evidenced by detectable viral load by PCR) or acquired
immunodeficiency syndrome (AIDS) related illness
6. Current evidence of = grade 2 underlying pulmonary disease
7. Certain exclusionary prior treatments
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/11/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
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Actual
27/04/2023
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Sample size
Target
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Accrual to date
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Final
50
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Recruitment in Australia
Recruitment state(s)
Melbourne, VICNSW,SA,VIC
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Recruitment hospital [1]
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St. Vincent's Hospital Melbourne - Fitzroy
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Recruitment hospital [2]
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Southern Highlands Cancer Centre - Bowral
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Recruitment hospital [3]
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Macquarie University Hospital (Clinical Trials Unit) - Macquarie
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Recruitment hospital [4]
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Cancer Research South Australia - Adelaide
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Recruitment hospital [5]
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Sunshine Hospital - Western Health - Saint Albans
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Recruitment hospital [6]
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Goulburn Valley Health - Shepparton
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Recruitment postcode(s) [1]
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3065 - Fitzroy
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Recruitment postcode(s) [2]
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2576 - Bowral
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Recruitment postcode(s) [3]
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2109 - Macquarie
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Recruitment postcode(s) [4]
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5000 - Adelaide
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Recruitment postcode(s) [5]
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3021 - Saint Albans
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Recruitment postcode(s) [6]
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3630 - Shepparton
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Florida
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Illinois
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Michigan
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Minnesota
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Missouri
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North Carolina
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South Carolina
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Tennessee
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Texas
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New Zealand
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Christchurch
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Molecular Templates, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This will be a Phase 1b, first in human, open-label, dose escalation and expansion study of
MT-5111 (a recombinant fusion protein) given as monotherapy in subjects with HER2-positive
solid tumors
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04029922
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Public notes
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Contacts
Principal investigator
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04029922
Download to PDF