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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06478693




Registration number
NCT06478693
Ethics application status
Date submitted
24/06/2024
Date registered
27/06/2024
Date last updated
21/08/2024

Titles & IDs
Public title
A Study of MT-303 in Adults With Advanced or Metastatic GPC3-Expressing Cancers, Including HCC
Scientific title
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
Secondary ID [1] 0 0
MTX-GPC3-303
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatocellular Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MT-303

Experimental: MT-303 - Participants will receive MT-303 through intravenous infusion.


Treatment: Drugs: MT-303
MT-303
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Type, incidence and severity of Adverse Events
Timepoint [1] 0 0
Up to 2 years from the last dose of Investigational Medicinal Product (IMP)
Primary outcome [2] 0 0
Recommended Phase 2 Dose (RP2D)
Timepoint [2] 0 0
28 days from the last dose of IMP
Primary outcome [3] 0 0
Change from baseline in vital signs
Timepoint [3] 0 0
Up to 30 days from the last dose of IMP
Primary outcome [4] 0 0
Change in laboratory parameters
Timepoint [4] 0 0
Up to 30 days from the last dose of IMP
Primary outcome [5] 0 0
Change from baseline in ECG parameters
Timepoint [5] 0 0
Screening, Day 1 and Day 15
Secondary outcome [1] 0 0
To assess the pharmacokinetics (PK) of MT-303
Timepoint [1] 0 0
Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP
Secondary outcome [2] 0 0
To assess the pharmacokinetics (PK) of MT-303
Timepoint [2] 0 0
Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP
Secondary outcome [3] 0 0
To assess the pharmacokinetics (PK) of MT-303
Timepoint [3] 0 0
Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP
Secondary outcome [4] 0 0
To assess the pharmacokinetics (PK) of MT-303
Timepoint [4] 0 0
Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP
Secondary outcome [5] 0 0
To assess the pharmacokinetics (PK) of MT-303
Timepoint [5] 0 0
Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP
Secondary outcome [6] 0 0
To assess the pharmacokinetics (PK) of MT-303
Timepoint [6] 0 0
Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP
Secondary outcome [7] 0 0
To assess the pharmacokinetics (PK) of MT-303
Timepoint [7] 0 0
Day 1, 2, 3, 8, 15 and once every 28 days post first dose of IMP
Secondary outcome [8] 0 0
To assess adverse events of special interest (AESI) by measuring infusion reaction
Timepoint [8] 0 0
upto 2 years from the last dose of IMP
Secondary outcome [9] 0 0
To assess adverse events of special interest (AESI) by measuring cytokine release syndrome (CRS)
Timepoint [9] 0 0
Up to 2 years from the last dose of IMP
Secondary outcome [10] 0 0
To assess adverse events of special interest (AESI) by measuring immune effector cell-associated neurotoxicity syndrome (ICANS)
Timepoint [10] 0 0
Up to 2 years from the last dose of IMP
Secondary outcome [11] 0 0
To assess adverse events of special interest (AESI) by measuring hypersensitivity reaction
Timepoint [11] 0 0
Up to 2 years from the last dose of IMP
Secondary outcome [12] 0 0
To assess adverse events of special interest (AESI) by checking for second primary malignancy
Timepoint [12] 0 0
upto 2 years from the last dose of IMP

Eligibility
Key inclusion criteria
Inclusion Criteria

* Aged 18 years or older
* Histological diagnosis of advanced/recurrent or metastatic and/or unresectable HCC. [Note: participants with other tumor types expressing GPC3 may be eligible pending a discussion with the Medical Monitor]
* Measurable lesion per RECIST 1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status grade of 0 or 1
* Child-Pugh score: Class A
* Adequate organ function
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Known active central nervous system (CNS) metastasis and/or carcinomatous meningitis.
* Any acute illness including active infection
* History of liver transplantation or on waiting list
* Participants with untreated or incompletely treated varices with bleeding or high risk for bleeding
* Uncontrolled pleural effusion, pericardial effusion, or ascites
* History of symptomatic congestive heart failure
* History of chronic or recurrent (within the last year) severe autoimmune or immune mediated disease requiring steroids or other immune-suppressive treatments.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2026
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [2] 0 0
Integrated Clinical Oncology Network (ICON) Pty Ltd - Woolloongabba
Recruitment hospital [3] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [4] 0 0
Linear Clinical Research - Murdoch
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
6150 - Murdoch

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Myeloid Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a multicenter, open-label, Phase 1, first-in-human, dose-escalation study designed to assess the safety, tolerability and define the RP2D of MT-303 in participants with advanced hepatocellular carcinoma expressing GPC3.
Trial website
https://clinicaltrials.gov/study/NCT06478693
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Matthew Maurer, MD
Address 0 0
Myeloid Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Project Manager
Address 0 0
Country 0 0
Phone 0 0
+61 2 8569 1400
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06478693