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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06199908




Registration number
NCT06199908
Ethics application status
Date submitted
21/12/2023
Date registered
10/01/2024
Date last updated
26/07/2024

Titles & IDs
Public title
AMT-562 in Patients With Selected Advanced Solid Tumors
Scientific title
First-in-Human, Phase 1 Study of AMT-562 in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
AMT-562-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumors 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMT-562

Experimental: Arm 1 - AMT-562 Dose Escalation


Treatment: Drugs: AMT-562
Administered AMT-562 for injection intravenously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
DLTs
Timepoint [1] 0 0
up to 24 month
Primary outcome [2] 0 0
AEs
Timepoint [2] 0 0
up to 24 month
Primary outcome [3] 0 0
SAEs
Timepoint [3] 0 0
up to 24 month
Secondary outcome [1] 0 0
Cmax
Timepoint [1] 0 0
up to 24 month
Secondary outcome [2] 0 0
Tmax
Timepoint [2] 0 0
up to 24 month
Secondary outcome [3] 0 0
AUC
Timepoint [3] 0 0
up to 24 month
Secondary outcome [4] 0 0
t1/2
Timepoint [4] 0 0
up to 24 month
Secondary outcome [5] 0 0
ADAs
Timepoint [5] 0 0
up to 24 month
Secondary outcome [6] 0 0
ORR
Timepoint [6] 0 0
up to 24 month
Secondary outcome [7] 0 0
DCR
Timepoint [7] 0 0
up to 24 month
Secondary outcome [8] 0 0
PFS
Timepoint [8] 0 0
up to 24 month
Secondary outcome [9] 0 0
TTR
Timepoint [9] 0 0
up to 24 month
Secondary outcome [10] 0 0
DOR
Timepoint [10] 0 0
up to 24 month

Eligibility
Key inclusion criteria
* 1. Patients must be willing and able to understand and sign the ICF, and to adhere to the study visit schedule and other protocol requirements.
* 2. Age =18 years (at the time consent is obtained).
* 3. Patients with histologically confirmed unresectable advanced solid tumor.
* 4. Patients who have undergone at least one systemic therapy and have radiologically or clinically determined progressive disease (PD) during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable to standard therapy.
* 5. Patients must have at least one measurable lesion as per RECIST version 1.1.
* 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
* 7. Life expectancy = 3 months.
* 8. Patients must have adequate organ function
* 9. Women of child bearing potential (WCBP), defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months) must agree to use two effective contraceptive methods while on study treatment and for at least twelve weeks after the last dose of the IMP.
* 10. WCBP must have a negative serum pregnancy test within 7 days prior to first dose of the IMP.
* 11. Male patients must agree to use a latex condom, even if they had a successful vasectomy, while on study treatment and for at least twelve weeks after the last dose of the IMP.
* 12. Male patients must agree not to donate sperm, and female patients must agree not to donate eggs, while on study treatment and for at least 12 weeks after the last dose of the IMP.
* 13. Availability of tumor tissue sample (either an archival specimen or a fresh biopsy material) at screening.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 1. Central nervous system (CNS) metastasis.
* 2. Active or chronic skin disorder requiring systemic therapy.
* 3. History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.
* 4. Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1.
* 5. Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to first dose of the IMP.
* 6. Radiotherapy to lung field at a total radiation dose of = 20 Gy within 6 months, wide-field radiotherapy within 28 days.
* 7. Major surgery within 28 days prior to first dose of the IMP, or no recovery from side effects of such intervention.
* 8. Significant cardiac disease.
* 9. Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis t.
* 10. History of thromboembolic or cerebrovascular events, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis, or pulmonary emboli within six months prior to first dose of the IMP.
* 11. Acute and/or clinically significant bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV).
* 12. Administration of a live vaccine within 28 days prior to the administration of the first dose of the IMP.
* 13. Patients requiring concurrent treatment of strong inhibitors or inducers of cytochrome P450 3A or 1A2 enzyme (CYP3A or CYP1A2) within 2 weeks prior to the first dose and during the study treatment.
* 14. Known or suspected severe allergy/hypersensitivity (resulting in treatment discontinuation) to monoclonal antibodies.
* 15. Known or suspected intolerance to the components of the IMP.
* 16. Concurrent participation in another investigational therapeutic clinical trial.
* 17. Patients with known active alcohol or drug abuse.
* 18. Pregnant or breast-feeding females.
* 19. Mental or medical conditions that prevent the patient from giving informed consent or complying with the trial or other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with the study participation or the IMP administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for enrolment in this study.
* 20. Prior history of malignancy other than inclusion diagnosis within five years prior to first dose of the IMP.

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
Single group
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
20/05/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Macquarie University Hospital - North Ryde
Recruitment hospital [2] 0 0
Cabrini Malvern Hospital - Malvern
Recruitment postcode(s) [1] 0 0
- North Ryde
Recruitment postcode(s) [2] 0 0
- Malvern

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Multitude Therapeutics (Australia) Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a first-in-human, non-randomized, open-label, multicenter Phase 1 study of AMT-562 in patients with advanced solid tumors.
Trial website
https://clinicaltrials.gov/study/NCT06199908
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Minqi Guan
Address 0 0
Country 0 0
Phone 0 0
86-15895820062
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/NCT06199908