Actively Recruiting
AMT-676 in Patients With Advanced Solid Tumors
Led by Multitude Therapeutics Inc. · Updated on 2025-05-02
24
Participants Needed
13
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a first-in-human, non-randomized, open-label, multicenter Phase 1 study will evaluate the Maximum tolerated dose (MTD)/the recommended Phase 2 Dose (RP2D), safety, tolerability, anti-drug activity, pharmacokinetics, pharmacodynamics and immunogenicity of AMT-676 in Patients with Advanced Solid Tumors.
CONDITIONS
Official Title
AMT-676 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients willing and able to sign informed consent and follow study visits and protocol
- Age 18 years or older at consent
- Pathologically confirmed unresectable advanced solid tumor, including colorectal, gastric, esophageal adenocarcinoma, cholangiocarcinoma, pancreatic ductal cancers, and neuroendocrine tumors
- Prior treatment with at least one systemic therapy and documented progressive disease during or after most recent therapy, with no further standard therapy available or intolerance to standard therapy
- At least one measurable lesion per RECIST version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Life expectancy of at least 3 months
- Adequate organ function
- Women of child-bearing potential must have a negative serum pregnancy test
- Male patients must agree to use latex condoms during treatment and for 6 months after last dose
- Male patients must agree not to donate sperm, and female patients must agree not to donate eggs during treatment and for 3 and 6 months respectively after last dose
- Availability of tumor tissue sample at screening
You will not qualify if you...
- Prior treatment with agents targeting the same mechanism or ADC based on topoisomerase I inhibitor
- Central nervous system metastasis
- History of Stevens-Johnson syndrome or toxic epidermal necrolysis
- Persistent toxicities greater than grade 1 from previous treatments
- Systemic anti-neoplastic therapy within 21 days or five half-lives prior to first dose
- Radiotherapy to lung field with dose ≥20 Gy within 6 months or wide-field radiotherapy within 28 days
- Major surgery (excluding vascular access or biopsies) within 28 days without recovery
- Significant cardiac disease including recent myocardial infarction, acute coronary syndromes, congestive heart failure (NYHA class III or IV), uncontrolled hypertension, or arrhythmias
- History or current interstitial lung disease or pneumonitis requiring steroids or significantly impacting lung function
- Thromboembolic or cerebrovascular events within 6 months prior to first dose
- Active bacterial, fungal, or viral infection including hepatitis B, hepatitis C, or HIV
- Live vaccine administration within 28 days prior to first dose
- Concurrent treatment with strong CYP3A4 or CYP1A2 inhibitors or inducers
- Known or suspected severe allergy to monoclonal antibodies
- Known intolerance to study drug components
- Participation in another investigational therapeutic trial
- Active alcohol or drug abuse
- Pregnant or breastfeeding females
- Medical or psychiatric conditions preventing informed consent or compliance, or increasing risk
- History of other malignancy within 5 years except the current diagnosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Carolina Biooncology Institute
Huntersville, North Carolina, American Samoa, 28078
Not Yet Recruiting
2
John Hopkins Sidney Kimmel Comprehensive Cancer Center
Philadelphia, Pennsylvania, American Samoa, 19107
Not Yet Recruiting
3
South Texas Accelerated Research Therapeutics (start) San Antonio
San Antonio, Texas, American Samoa
Not Yet Recruiting
4
SCIENTIA Clinical Research Ltd
Randwick, New South Wales, Australia
Actively Recruiting
5
Macquarie University Hospital
Macquarie, New South wWales, Australia
Actively Recruiting
6
Gallipoli Medical Research Foundation
Greenslopes, Queensland, Australia
Actively Recruiting
7
Cabrini Hospital
Melbourne, Victoria, Australia
Actively Recruiting
8
Linear Research
Nedlands, Western Australia, Australia
Actively Recruiting
9
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China, 350014
Not Yet Recruiting
10
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Not Yet Recruiting
11
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200000
Not Yet Recruiting
12
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610000
Not Yet Recruiting
13
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China, 310016
Not Yet Recruiting
Research Team
J
Jane 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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