Trial Title:
AMT-676 in Patients With Advanced Solid Tumors
NCT ID:
NCT06400485
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
AMT-676
Description:
Participants will receive AMT-676 administered intravenously. Participants will be
observed for first instance of dose limiting toxicities (DLT).
Arm group label:
AMT-676 Dose escalation
Summary:
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.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
1. Patients must be willing and able to sign the ICF, and to adhere to the study visit
Schedule and other protocol requirements.
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 12 weeks 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 12 weeks after the last dose
of the IMP.
12. Availability of tumour tissue sample (either an archival specimen or a fresh biopsy
material) at screening.
Key Exclusion Criteria:
1. Prior treatment with any agent for the same target.
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
SCIENTIA Clinical Research Ltd
Address:
City:
Randwick
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Charlotte Lemech
Email:
charlotte.lemech@scientiaclinicalresearch.com
Facility:
Name:
Macquarie University Hospital
Address:
City:
Macquarie
Country:
Australia
Status:
Recruiting
Facility:
Name:
Gallipoli Medical Research Foundation
Address:
City:
Greenslopes
Country:
Australia
Status:
Recruiting
Facility:
Name:
Cabrini Hospital
Address:
City:
Melbourne
Country:
Australia
Status:
Recruiting
Facility:
Name:
Linear Research
Address:
City:
Nedlands
Country:
Australia
Status:
Recruiting
Facility:
Name:
Fujian Provincial Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Robo Lin
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Ruihua Xu
Facility:
Name:
Shanghai East Hospital
Address:
City:
Shanghai
Zip:
200000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Junli Xue
Facility:
Name:
Sichuan Provincial People's Hospital
Address:
City:
Chengdu
Zip:
610000
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hao Liu
Facility:
Name:
Sir Run Run Shaw Hospital
Address:
City:
Hangzhou
Zip:
310016
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Hongming Pan
Start date:
June 18, 2024
Completion date:
February 14, 2026
Lead sponsor:
Agency:
Multitude Therapeutics Inc.
Agency class:
Industry
Source:
Multitude Therapeutics Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06400485
