Actively Recruiting
AMT-116 in Patients with Solid Tumors
Led by Multitude Therapeutics Inc. · Updated on 2025-01-17
144
Participants Needed
7
Research Sites
138 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety and efficacy of AMT-116 monotherapy in subjects with advanced solid tumors. The study is divided into two parts: the part I is dose escalation and the Part Ⅱ for expansion.
CONDITIONS
Official Title
AMT-116 in Patients with Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be willing and able to sign the informed consent form and follow study requirements
- Age 18 years or older at consent
- Histologically confirmed, unresectable advanced solid tumor, including preferred tumor types like non-small cell lung, head and neck, esophageal, cervical, breast, bladder, gastric, biliary tract, skin squamous cell, liver, and basal cell cancer
- Patients have had at least one systemic therapy and show progressive disease or intolerance to standard therapies
- At least one measurable lesion per RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Expected survival of at least three months
- Adequate organ function
- Women of child-bearing potential must agree to use two effective contraceptive methods during treatment and for 12 weeks after
- Women of child-bearing potential must have a negative pregnancy test within 7 days before first treatment
- Male patients must agree to use a latex condom during treatment and for 12 weeks after
- Male patients must agree not to donate sperm and female patients must agree not to donate eggs during treatment and for 12 weeks after
- Availability of tumor tissue sample at screening
You will not qualify if you...
- Prior therapy with antibody drug conjugates based on Top1 inhibitors
- Presence of central nervous system metastasis
- Active or chronic skin disorders requiring systemic therapy
- History of Stevens-Johnson syndrome or toxic epidermal necrolysis
- Active eye conditions needing treatment or close monitoring, such as macular degeneration or diabetic retinopathy with macular edema
- Persistent toxicities from previous anti-cancer treatments above Grade 1
- Systemic anti-cancer therapy within 21 days or five half-lives before first dose
- Recent radiotherapy to lung field with dose ≥20 Gy within 6 months or wide-field radiotherapy within 28 days
- Major surgery within 28 days before first dose or not recovered from surgery side effects
- Significant cardiac disease including recent heart attack, unstable angina, severe heart failure, uncontrolled hypertension or arrhythmias
- History or current interstitial lung disease or pneumonitis requiring steroids
- Thromboembolic or cerebrovascular events within 6 months prior to first dose
- Active bacterial, fungal, or viral infections including hepatitis B, hepatitis C, or HIV
- Live vaccine administration within 28 days before first dose
- Concurrent use of strong CYP3A4 inhibitors or inducers within 2 weeks before and during study
- Severe allergy or intolerance to monoclonal antibodies or investigational product components
- Participation in another investigational therapeutic clinical trial
- Known active alcohol or drug abuse
- Pregnant or breastfeeding females
- Medical or psychiatric disorders preventing informed consent or compliance
- History of other malignant tumors within 5 years prior to first dose
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Fujian Cancer Hospital
Fuzhou, Fujian, China
Actively Recruiting
2
Dongguan People's Hospital
Dongguan, Guangdong, China
Not Yet Recruiting
3
Zhujiang Hospital of Southern Medical University(The Second Clinical Medical College)
Guangzhou, Guangdong, China
Actively Recruiting
4
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Actively Recruiting
5
Hunan Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
6
Zhejiang cancer hospital
Hangzhou, Zhejiang, China
Actively Recruiting
7
The Second Affiliated Hospital and Yuying Childrens Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Actively Recruiting
Research Team
Y
Yixuan Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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