Trial Review

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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/NCT05906862




Registration number
NCT05906862
Ethics application status
Date submitted
7/06/2023
Date registered
18/06/2023
Date last updated
15/11/2023

Titles & IDs
Public title
AMT-253 in Patients With Selected Advanced Solid Tumours
Scientific title
First-in-Human, Phase 1 Study of AMT-253, in Patients With Advanced Solid Tumors
Secondary ID [1] 0 0
AMT-253-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMT-253

Experimental: AMT-253 Dose Escalation -


Treatment: Drugs: AMT-253
Administered intravenously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recommended Phase 2 Dose (RP2D)
Timepoint [1] 0 0
Up to 24 months
Primary outcome [2] 0 0
Maximum Tolerated Dose (MTD)
Timepoint [2] 0 0
Up to 24 months
Primary outcome [3] 0 0
Type, incidence and severity of Adverse Events
Timepoint [3] 0 0
Up to 24 months
Secondary outcome [1] 0 0
Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Timepoint [1] 0 0
Up to 24 months
Secondary outcome [2] 0 0
Disease Control Rate (DCR) according to the RECIST v1.1
Timepoint [2] 0 0
Up to 24 months
Secondary outcome [3] 0 0
Progression-free Survival (PFS)
Timepoint [3] 0 0
Up to 24 months
Secondary outcome [4] 0 0
Concentration of anti-drug antibodies (ADA)
Timepoint [4] 0 0
Up to 24 months
Secondary outcome [5] 0 0
Maximum observed concentration (C[max])
Timepoint [5] 0 0
Up to 24 months
Secondary outcome [6] 0 0
Area under the curve (AUC)
Timepoint [6] 0 0
Up to 24 months
Secondary outcome [7] 0 0
Terminal half-life (t[1/2])
Timepoint [7] 0 0
Up to 24 months
Secondary outcome [8] 0 0
Time to maximum concentration (Tmax)
Timepoint [8] 0 0
Up to 24 months

Eligibility
Key inclusion criteria
Key

- Patients must be willing and able to sign the ICF, and to adhere to the study visit
schedule and other protocol requirements.

- Age =18 years (at the time consent is obtained).

- Patients who have undergone at least one systemic therapy and have radiologically or
clinically determined progressive disease during or after most recent line of therapy,
and for whom no further standard therapy is available, or who are intolerable to
standard therapy.

- Patients must have at least one measurable lesion as per RECIST version 1.1

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

- Life expectancy = 3 months.

- Patients must have adequate organ function.

- 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 (examples
include oral, parenteral, or implantable hormonal contraceptive, intra-uterine device,
barrier contraceptive with spermicide, partner's latex condom or vasectomy) while on
study treatment and for at least twelve weeks after the last dose of the IMP.

- WCBP must have a negative serum pregnancy test within 7 days prior to first dose of
the IMP.

- 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.

- 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.

- Availability of tumor tissue sample (either an archival specimen or a fresh biopsy
material) at screening.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Central nervous system (CNS) metastasis.

- Active or chronic skin disorder requiring systemic therapy.

- History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.

- Active ocular conditions requiring treatment or close monitoring, including, but not
limited to: macular degeneration, papilledema, active diabetic retinopathy with
macular oedema, wet age-related macular degeneration requiring intravitreal
injections, or uncontrolled glaucoma.

- Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1.

- Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is
shorter, prior to first dose of the IMP.

- Radiotherapy to lung field at a total radiation dose of =20 Gy within 6 months,
wide-field radiotherapy (e.g., > 30% of marrow-bearing bones) within 28 days.

- Major surgery (not including placement of vascular access device or tumor biopsies)
within 28 days prior to first dose of the IMP, or no recovery from side effects of
such intervention.

- Significant cardiac disease, such as recent (within six months prior to first dose of
the IMP) myocardial infarction or acute coronary syndromes (including unstable angina
pectoris), congestive heart failure (New York Heart Association class III or IV),
uncontrolled hypertension, uncontrolled cardiac arrhythmias.

- Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that
required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis (e.g.,
idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis,
idiopathic pneumonitis, etc.).

- 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.

- Acute and/or clinically significant bacterial, fungal or viral infection including
hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV).

- Administration of a live vaccine within 28 days prior to the administration of the
first dose of the IMP.

- Patients requiring concurrent treatment of strong inhibitors or inducers of cytochrome
P450 3A4 or 1A2 enzyme (CYP3A4 or CYP1A2) within 2 weeks prior to the first dose and
during the study treatment.

- Patient who has active graft versus host disease, or diagnosis of immunodeficiency, or
has an active autoimmune disease or other conditions that require systemic steroid
therapy, i.e. > 10 mg daily prednisone equivalents within 14 days prior to the
administration of the first dose; the use of short-course systemic corticosteroids (=
7 days) is permitted, with a wash-out period of 1 week prior to the administration of
the first dose of the IMP.

- Known or suspected severe allergy/hypersensitivity (resulting in treatment
discontinuation) to monoclonal antibodies.

- Known or suspected intolerance to the components of the IMP.

- Concurrent participation in another investigational therapeutic clinical trial.

- Patients with known active alcohol or drug abuse.

- Pregnant or breast-feeding females.

- 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.

- Prior history of malignancy other than inclusion diagnosis within five years prior to
first dose of the IMP.

Note: Other protocol defined Inclusion/Exclusion criteria apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
6/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/02/2026
Actual
Sample size
Target
54
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Blacktown - Sydney
Recruitment hospital [2] 0 0
Chris O'Brien Lifehouse - Sydney
Recruitment hospital [3] 0 0
Maquarie University Hospital - Sydney
Recruitment hospital [4] 0 0
ICON Cancer Centre - Brisbane
Recruitment hospital [5] 0 0
Southern Oncology Clinical Research - Adelaide
Recruitment hospital [6] 0 0
Cabrini Malvern Hospital - Malvern
Recruitment hospital [7] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- Adelaide
Recruitment postcode(s) [4] 0 0
- Malvern
Recruitment postcode(s) [5] 0 0
VIC 3004 - Melbourne

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 first-in-human study will evaluate the Maximum Tolerated Dose (MTD) / the Recommended
Phase 2 Dose (RP2D), safety, tolerability, anti-tumor activity, pharmacokinetics,
pharmacodynamics and immunogenicity of AMT-253, in Patients with Advanced Solid Tumors
Trial website
https://clinicaltrials.gov/ct2/show/NCT05906862
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
Jane Zhu
Address 0 0
Country 0 0
Phone 0 0
13917933915
Fax 0 0
Email 0 0
juanjuan.zhu@multitudetherapeutics.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05906862