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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
EARLY_PHASE1
24 participants
INTERVENTIONAL
2024-06-18
2026-02-14
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
AMT-116 in Patients With Advanced Solid Tumors
NCT05725291
AMT-253 in Patients With Selected Advanced Solid Tumours
NCT05906862
AMT-562 in Patients With Selected Advanced Solid Tumors
NCT06199908
First-in-Human Investigation of JMT108 Injection in Participants With Advanced Malignant Tumors
NCT06877650
First in Human Study to Evaluate the Safety, Tolerability of HH30134 in Advanced Solid Tumors
NCT04746612
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AMT-676 Dose escalation
Drug- AMT-676 Dosage level: AMT-676 will be administered as an intravenous (IV) infusion. Dosage form: Vial Route of administration: Intravenous Infusion
AMT-676
Participants will receive AMT-676 administered intravenously. Participants will be observed for first instance of dose limiting toxicities (DLT).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
AMT-676
Participants will receive AMT-676 administered intravenously. Participants will be observed for first instance of dose limiting toxicities (DLT).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age ≥18 years (at the time consent is obtained).
3. Patients with pathologically confirmed unresectable advanced solid tumor. Preferred tumor types include colorectal cancer, gastric cancer, esophageal adenocarcinoma, cholangiocarcinoma, pancreatic ductal cancers, and neuroendocrine tumors.
4. 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.
5. Patients must have at least one measurable lesion as per RECIST version 1.1.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
7. Life expectancy ≥3 months.
8. Patients must have adequate organ function
9. Women of child-bearing potential (WCBP) must have a negative serum pregnancy test.
10. Male patients must agree to use a latex condom, even if they had a successful vasectomy, while on study treatment and for at least 6months after the last dose of the IMP.
11. 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 3 months and 6 months, respectively after the last dose of the IMP.
12. Availability of tumour tissue sample (either an archival specimen or a fresh biopsy material) at screening.
Exclusion Criteria
2. Central nervous system (CNS) metastasis
3. History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.
4. Persistent toxicities from previous systemic anti-neoplastic treatments of Grade \>1.
5. Systemic anti-neoplastic therapy within five half-lives or21 days, whichever is shorter, prior to first dose of the IMP.
6. 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.
7. Major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to first dose of the IMP, or no recovery from side effects of such intervention.
8. Significant cardiac disease, such as recent (within 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 (SBP ≥ 160mmHg or DBP ≥ 100mmHg), uncontrolled cardiac arrhythmias.
9. Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or current ILD/pneumonitis, or suspected ILD/pneumonitis (e.g., idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, etc.) or other lung disease significantly impacting lung function at baseline.
10. History of thromboembolic or cerebrovascular events, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis, or pulmonary emboli within six months prior to first dose of the IMP.
11. Acute and/or clinically significant bacterial, fungal or viral infection including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV)
12. Administration of a live vaccine within 28 days prior to the administration of the first dose of the IMP.
13. Patients requiring concurrent treatment of strong inhibitors or inducers of cytochrome P450 3A4 or 1A2 enzyme (CYP3A or CYP1A2) within 2 weeks prior to the first dose and during the study treatment.
14. Known or suspected severe allergy/hypersensitivity (resulting in treatment discontinuation) to monoclonal antibodies.
15. Known or suspected intolerance to the components of the IMP.
16. Concurrent participation in another investigational therapeutic clinical trial.
17. Patients with known active alcohol or drug abuse.
18. Pregnant or breast-feeding females
19. Mental or medical conditions that prevent the patient from giving informed consent or complying with the trial or other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with the study participation or the IMP administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for enrolment in this study.
20. Prior history of malignancy other than inclusion diagnosis within five years prior to first dose of the IMP.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Multitude Therapeutics Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Carolina Biooncology Institute
Huntersville, North Carolina, American Samoa
John Hopkins Sidney Kimmel Comprehensive Cancer Center
Philadelphia, Pennsylvania, American Samoa
South Texas Accelerated Research Therapeutics (start) San Antonio
San Antonio, Texas, American Samoa
SCIENTIA Clinical Research Ltd
Randwick, New South Wales, Australia
Macquarie University Hospital
Macquarie, New South wWales, Australia
Gallipoli Medical Research Foundation
Greenslopes, Queensland, Australia
Cabrini Hospital
Melbourne, Victoria, Australia
Linear Research
Nedlands, Western Australia, Australia
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Robo Lin
Role: primary
Ruihua Xu
Role: primary
Junli Xue
Role: primary
Hao Liu
Role: primary
Hongming Pan
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AMT-676-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.