Actively Recruiting
Phase 1/2 Study of AMT-116 Antibody Drug Conjugate in Patients with Advanced 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
Researchers are evaluating the safety and effectiveness of AMT-116, an antibody drug conjugate, as a single treatment in patients with advanced solid tumors. The study focuses on patients with tumors such as non-small cell lung, head and neck, esophageal, cervical, breast, bladder, gastric, biliary tract, skin squamous cell, liver, and basal cell cancers. This clinical trial includes two phases: Phase 1 for dose escalation and Phase 2 for further expansion and evaluation. Participants will receive AMT-116 monotherapy, with the study divided into two parts. In Phase 1, the goal is to find the maximum tolerated dose and the recommended dose for Phase 2 over about 12 months. Phase 2 will assess the objective response rate and monitor adverse events for approximately 18 months. The study includes careful dose management and monitoring for side effects throughout the treatment periods. During the trial, participants will undergo various assessments including tumor measurements according to RECIST version 1.1, monitoring for adverse events, and evaluations of overall health and organ function. Women of child-bearing potential and male patients must follow specific contraceptive guidelines during and after treatment. Safety and effectiveness will be closely tracked for up to 18 months, with researchers collecting necessary tissue samples and monitoring for treatment response and side effects throughout the study.
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here