Trial Title:
AMT-253 in Patients With Selected Advanced Solid Tumours
NCT ID:
NCT05906862
Condition:
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AMT-253
Description:
Administered intravenously
Arm group label:
AMT-253 Dose Escalation
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
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- 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 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Blacktown
Address:
City:
Sydney
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Gao Bo
Facility:
Name:
Chris O'Brien Lifehouse
Address:
City:
Sydney
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Steven Kao
Phone:
61 02 8514 0140
Facility:
Name:
Maquarie University Hospital
Address:
City:
Sydney
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
John Park
Facility:
Name:
ICON Cancer Centre
Address:
City:
Brisbane
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Jermaine Coward
Facility:
Name:
Southern Oncology Clinical Research
Address:
City:
Adelaide
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Ganessan Kichenadasse
Facility:
Name:
Cabrini Malvern Hospital
Address:
City:
Malvern
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Richardson Gary
Phone:
61 03 9508 9542
Facility:
Name:
Alfred Hospital
Address:
City:
Melbourne
Zip:
VIC 3004
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Mark Voskoboynik
Start date:
November 6, 2023
Completion date:
February 28, 2026
Lead sponsor:
Agency:
Multitude Therapeutics (Australia) Pty Ltd
Agency class:
Industry
Source:
Multitude Therapeutics Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05906862
