Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
80 participants
INTERVENTIONAL
2023-07-25
2026-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AMT-116 Dose Escalation
AMT-116
Administered intravenously
Interventions
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AMT-116
Administered intravenously
Eligibility Criteria
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Inclusion Criteria
* 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.
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 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.
18 Years
ALL
No
Sponsors
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Multitude Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jermaine Coward
Role: PRINCIPAL_INVESTIGATOR
ICON Cancer Centre
Locations
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Sarah Cannon Research Institute
Denver, Colorado, United States
Mary Crowley Cancer Research Centers
Dallas, Texas, United States
University of California San Francisco Cancer Center
San Francisco, California, American Samoa
Carolina BioOncology Institute, LLC
Cary, North Carolina, American Samoa
Macquarie University Hospital
Sydney, New South Wales, Australia
ICON Cancer Centre
Brisbane, Queensland, Australia
Southern Oncology Clinical Research Unit
Adelaide, South Australia, Australia
Alfred Hospital
Victoria Park, Victoria, Australia
Austin Health
Victoria Park, Victoria, Australia
Cabrini Hospital
Victoria Park, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Perez Batista Cesar Augusto
Role: primary
Orr Douglas
Role: primary
Munster Pamela
Role: primary
Powderly John
Role: primary
Park John
Role: primary
Jermaine Coward
Role: primary
Kichenadasse Ganessan
Role: primary
Voskoboynik Mark
Role: primary
Parakh Sagun
Role: primary
Richardson Gary
Role: primary
Other Identifiers
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AMT-116-01
Identifier Type: -
Identifier Source: org_study_id
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