Trial Title:
AMT-116 in Patients With Advanced Solid Tumors
NCT ID:
NCT05725291
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-116
Description:
Administered intravenously
Arm group label:
AMT-116 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-116, 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 with histologically confirmed, unresectable advanced solid tumor. Preferred
tumor types include head and neck, non-small cell lung, esophageal, pancreatic,
large cell lung, colorectal, cervical, breast, bladder, gastric, biliary tract, skin
squamous cell, liver, and basal cell cancer.
- 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.
- Both male and female patients must agree to use effective contraceptive methods.
- Patients must have adequate organ function.
- Women of child-bearing potential (WCBP) must have a negative serum pregnancy test.
- Male patients must agree to use a latex condom, even if they had a successful
vasectomy, while on study treatment and for at least 12 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 tumour tissue sample (either an archival specimen or a fresh biopsy
material) at screening.
Key Exclusion Criteria:
- Prior therapy with ADC based on Top1 inhibitor.
- 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 the first dose of the IMP, or no recovery from side effects
of such intervention.
- Prior allogeneic or autologous bone marrow transplantation.
- 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.
- Pregnant or breast-feeding females.
Note: Other protocol defined Inclusion/Exclusion criteria apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sarah Cannon Research Institute
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Perez Batista Cesar Augusto
Facility:
Name:
Mary Crowley Cancer Research Centers
Address:
City:
Dallas
Zip:
75230
Country:
United States
Status:
Recruiting
Contact:
Last name:
Orr Douglas
Facility:
Name:
Carolina BioOncology Institute, LLC
Address:
City:
Cary
Zip:
28078
Country:
American Samoa
Status:
Recruiting
Contact:
Last name:
Powderly John
Facility:
Name:
University of California San Francisco Cancer Center
Address:
City:
San Francisco
Zip:
94115
Country:
American Samoa
Status:
Not yet recruiting
Contact:
Last name:
Munster Pamela
Facility:
Name:
Macquarie University Hospital
Address:
City:
Syd
Zip:
2109
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Park John
Facility:
Name:
ICON Cancer Centre
Address:
City:
Brisbane
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Jermaine Coward
Facility:
Name:
Southern Oncology Clinical Research Unit
Address:
City:
Adelaide
Zip:
5042
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Kichenadasse Ganessan
Facility:
Name:
Alfred Hospital
Address:
City:
Victoria Park
Zip:
3004
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Voskoboynik Mark
Facility:
Name:
Austin Health
Address:
City:
Victoria Park
Zip:
3084
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Parakh Sagun
Facility:
Name:
Cabrini Hospital
Address:
City:
Victoria Park
Zip:
3144
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Richardson Gary
Start date:
July 25, 2023
Completion date:
July 30, 2025
Lead sponsor:
Agency:
Multitude Therapeutics Inc.
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/NCT05725291
