AMT-151 in Patients With Selected Advanced Solid Tumours
NCT ID: NCT05498597
Last Updated: 2023-10-19
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
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UNKNOWN
PHASE1
30 participants
INTERVENTIONAL
2023-01-25
2024-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AMT-151 Dose Escalation
AMT-151
Administered intravenously
Interventions
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AMT-151
Administered intravenously
Eligibility Criteria
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Inclusion Criteria
* Age ≥18 years (at the time consent is obtained).
* Patients with the following histologically confirmed, advanced cancer diagnoses:
1. Serous, endometrioid, clear-cell, or mucinous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
2. Serous, endometrioid, or clear-cell endometrial cancer.
3. Adenocarcinoma of the lung.
4. Triple-negative breast cancer.
5. Pancreatic ductal adenocarcinoma.
6. Malignant pleural mesothelioma.
* Patients who have undergone any number of prior systemic therapies and have radiologically or clinically determined progressive disease during or after their most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable to standard therapy.
* Patients must have at least one measurable or non-measurable lesion as per RECIST version 1.1.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Adequate function of bone marrow, liver, kidneys, heart.
* Both male and female patients must agree to use effective contraceptive methods.
* Women of child-bearing potential (WCBP) must have a negative serum pregnancy test.
* Availability of tumour tissue sample (either an archival specimen or a fresh biopsy material) at screening.
Exclusion Criteria
* Active central nervous system metastasis.
* Persistent toxicities from previous systemic anti-neoplastic treatments of Grade \>1.
* Systemic anti-neoplastic therapy within five half-lives or 21 days, whichever is shorter, prior to the first dose of the study drug.
* Radiotherapy to lung field at a total radiation dose of \>= 20 Gy within 6 months, wide-field radiotherapy (\>30% of marrow-bearing bones) within 28 days, or focal radiation for analgesic purpose or for lytic lesions at risk of fracture within 14 days prior to the first dose of the study drug, or no recovery from side effects of such intervention.
* Major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to the first dose of the study drug, or no recovery from side effects of such intervention.
* Prior allogeneic or autologous bone marrow transplantation.
* Significant cardiac or lung disease, active or chronic ocular disorders, thromboembolic or cerebrovascular events within 6 months prior to the first dose of the study drug, acute and/or clinically significant bacterial, fungal, or viral infection.
* Pregnant or breast-feeding females.
18 Years
ALL
No
Sponsors
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Tigermed Consulting Co., Ltd
INDUSTRY
Multitude Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Sarwan Bishnoi
Role: PRINCIPAL_INVESTIGATOR
Cancer Research SA
Richardson Gary
Role: PRINCIPAL_INVESTIGATOR
Cabrini Malvern Hospital
Steven Kao
Role: PRINCIPAL_INVESTIGATOR
Chris O'Brien Lifehouse
Catherine Shannon
Role: PRINCIPAL_INVESTIGATOR
Mater Cancer Care Centre
Jermaine Coward
Role: PRINCIPAL_INVESTIGATOR
ICON Cancer Centre
Mihitha Ariyapperuma
Role: PRINCIPAL_INVESTIGATOR
One Clinical Research (OCR)
Locations
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Chris O'Brien Lifehouse
Sydney, New South Wales, Australia
ICON Cancer Centre
Brisbane, Queensland, Australia
Mater Cancer Care Centre
South Brisbane, Queensland, Australia
Cancer Research SA
Adelaide, South Australia, Australia
Cabrini Malvern Hospital
Malvern, Victoria, Australia
One Clinical Research (OCR)
Perth, Western Australia, Australia
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, China
Hunan Cancer Hospital
Changsha, Hunan, China
Shanghai Tumor Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Steven Kao
Role: primary
Jermaine Coward
Role: primary
Catherine Shannon
Role: primary
Sarwan Bishnoi
Role: primary
Richardson Gary
Role: primary
Mihitha Ariyapperuma
Role: primary
An Lin, Director
Role: primary
Other Identifiers
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AMT-151-01
Identifier Type: -
Identifier Source: org_study_id
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