Trial Title:
AMT-151 in Patients With Selected Advanced Solid Tumours
NCT ID:
NCT05498597
Condition:
Advanced Solid Tumor
Advanced Cancer
Advanced Carcinoma
Ovarian Cancer
Ovarian Carcinoma
Ovarian Epithelial Cancer
Ovarian Endometrioid Adenocarcinoma
Endometrial Cancer
Endometrial Adenocarcinoma
Endometrial Serous Adenocarcinoma
Endometrial Endometrioid Adenocarcinoma
Endometrial Clear Cell Adenocarcinoma
Lung Adenocarcinoma
Triple Negative Breast Cancer
Pancreatic Ductal Adenocarcinoma
Malignant Pleural Mesothelioma
Ovarian Clear Cell Carcinoma
Ovarian Clear Cell Adenocarcinoma
Ovarian Mucinous Adenocarcinoma
Conditions: Official terms:
Carcinoma
Adenocarcinoma
Endometrial Neoplasms
Triple Negative Breast Neoplasms
Mesothelioma
Mesothelioma, Malignant
Carcinoma, Ovarian Epithelial
Adenocarcinoma of Lung
Cystadenocarcinoma, Serous
Carcinoma, Endometrioid
Adenocarcinoma, Clear Cell
Adenocarcinoma, Mucinous
Cystadenocarcinoma
Adenomyoepithelioma
Conditions: Keywords:
Carcinoma
Cancer
Antibody-Drug Conjugate
Folate Receptor Alpha
Study type:
Interventional
Study phase:
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-151
Description:
Administered intravenously
Arm group label:
AMT-151 Dose Escalation
Summary:
This first-in-human study will evaluate the Maximum Tolerated Dose (MTD) / the
Recommended Phase 2 Dose (RP2D), safety, tolerability, anti-tumor activity,
pharmacokinetics, pharmacodynamics and immunogenicity of AMT-151, a novel antibody-drug
conjugate against folate receptor alpha, in patients with selected advanced solid tumors.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
- Patients must be willing and able to sign the Informed Consent Form, and to adhere
to the study visit schedule and other protocol requirements.
- 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.
Key Exclusion Criteria:
- Prior treatment with any agent targeting Folate Receptor Alpha.
- 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.
Note: Other protocol defined Inclusion/Exclusion criteria apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chris O'Brien Lifehouse
Address:
City:
Sydney
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Steven Kao
Phone:
61 02 8514 0140
Facility:
Name:
ICON Cancer Centre
Address:
City:
Brisbane
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Jermaine Coward
Facility:
Name:
Mater Cancer Care Centre
Address:
City:
South Brisbane
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Catherine Shannon
Facility:
Name:
Cancer Research SA
Address:
City:
Adelaide
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Sarwan Bishnoi
Phone:
61 08 3592 565
Facility:
Name:
Cabrini Malvern Hospital
Address:
City:
Malvern
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Richardson Gary
Phone:
61 03 9508 9542
Facility:
Name:
One Clinical Research (OCR)
Address:
City:
Perth
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Mihitha Ariyapperuma
Phone:
61 08 6279 9466
Facility:
Name:
Fujian Provincial Cancer Hospital
Address:
City:
Fuzhou
Zip:
350014
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
An Lin, Director
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410031
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jing Wang, Director
Phone:
13875902083
Email:
wangjing0081@126.com
Facility:
Name:
Shanghai Tumor Hospital
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Jian Zhang, Director
Phone:
02164175590
Email:
syner2000@163.com
Contact backup:
Last name:
Xiaohua Wu, Director
Phone:
15618369676
Email:
edison-1016@163.com
Start date:
January 25, 2023
Completion date:
October 30, 2024
Lead sponsor:
Agency:
Multitude Therapeutics Inc.
Agency class:
Industry
Collaborator:
Agency:
Tigermed Consulting Co., Ltd
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/NCT05498597
