Actively Recruiting
AMT-116 in Patients With Advanced Solid Tumors
Led by Multitude Therapeutics Inc. · Updated on 2025-08-17
80
Participants Needed
10
Research Sites
179 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
AMT-116 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to sign informed consent and follow study schedule
- Age 18 years or older at consent
- Histologically confirmed unresectable advanced solid tumor, including specific types like head and neck, lung, esophageal, pancreatic, colorectal, cervical, breast, bladder, gastric, biliary tract, skin squamous cell, liver, and basal cell cancers
- Previously received at least one systemic therapy with progressive disease or intolerance to standard treatment
- At least one measurable lesion per RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Both males and females agree to use effective contraception
- Adequate organ function
- Women of child-bearing potential have a negative serum pregnancy test
- Male patients agree to use latex condoms during and for 12 weeks after treatment
- Male patients agree not to donate sperm and female patients agree not to donate eggs during and for 12 weeks after treatment
- Availability of tumor tissue sample at screening
You will not qualify if you...
- Prior therapy with antibody-drug conjugates based on Top1 inhibitor
- Presence of central nervous system 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 macular degeneration, papilledema, diabetic retinopathy with macular edema, wet age-related macular degeneration needing injections, or uncontrolled glaucoma
- Persistent toxicities greater than Grade 1 from previous systemic anti-cancer treatments
- Systemic anti-cancer therapy within five half-lives or 21 days before first dose
- Lung radiotherapy at doses 20 Gy or higher within 6 months or wide-field radiotherapy within 28 days
- Major surgery within 28 days before first dose without recovery
- Prior allogeneic or autologous bone marrow transplant
- Significant cardiac disease such as recent myocardial infarction, acute coronary syndromes, severe heart failure, uncontrolled hypertension, or arrhythmias
- Pregnant or breastfeeding females
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Sarah Cannon Research Institute
Denver, Colorado, United States, 80218
Not Yet Recruiting
2
Mary Crowley Cancer Research Centers
Dallas, Texas, United States, 75230
Actively Recruiting
3
University of California San Francisco Cancer Center
San Francisco, California, American Samoa, 94115
Not Yet Recruiting
4
Carolina BioOncology Institute, LLC
Cary, North Carolina, American Samoa, 28078
Actively Recruiting
5
Macquarie University Hospital
Sydney, New South Wales, Australia, 2109
Actively Recruiting
6
ICON Cancer Centre
Brisbane, Queensland, Australia
Actively Recruiting
7
Southern Oncology Clinical Research Unit
Adelaide, South Australia, Australia, 5042
Actively Recruiting
8
Alfred Hospital
Victoria Park, Victoria, Australia, 3004
Actively Recruiting
9
Austin Health
Victoria Park, Victoria, Australia, 3084
Actively Recruiting
10
Cabrini Hospital
Victoria Park, Victoria, Australia, 3144
Actively Recruiting
Research Team
J
Juanjuan Zhu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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