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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05498597




Registration number
NCT05498597
Ethics application status
Date submitted
10/08/2022
Date registered
12/08/2022
Date last updated
19/10/2023

Titles & IDs
Public title
AMT-151 in Patients With Selected Advanced Solid Tumours
Scientific title
First-in-Human, Phase 1 Study of AMT-151, an Anti-Folate Receptor Alpha Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours
Secondary ID [1] 0 0
AMT-151-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Solid Tumor 0 0
Advanced Cancer 0 0
Advanced Carcinoma 0 0
Ovarian Cancer 0 0
Ovarian Carcinoma 0 0
Ovarian Epithelial Cancer 0 0
Ovarian Endometrioid Adenocarcinoma 0 0
Endometrial Cancer 0 0
Endometrial Adenocarcinoma 0 0
Endometrial Serous Adenocarcinoma 0 0
Endometrial Endometrioid Adenocarcinoma 0 0
Endometrial Clear Cell Adenocarcinoma 0 0
Lung Adenocarcinoma 0 0
Triple Negative Breast Cancer 0 0
Pancreatic Ductal Adenocarcinoma 0 0
Malignant Pleural Mesothelioma 0 0
Ovarian Clear Cell Carcinoma 0 0
Ovarian Clear Cell Adenocarcinoma 0 0
Ovarian Mucinous Adenocarcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Breast
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMT-151

Experimental: AMT-151 Dose Escalation -


Treatment: Drugs: AMT-151
Administered intravenously
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Recommended Phase 2 Dose (RP2D)
Timepoint [1] 0 0
Up to 24 months
Primary outcome [2] 0 0
Maximum Tolerated Dose (MTD)
Timepoint [2] 0 0
Up to 24 months
Primary outcome [3] 0 0
Incidence of Adverse Events
Timepoint [3] 0 0
Up to 24 months
Secondary outcome [1] 0 0
Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
Timepoint [1] 0 0
Up to 24 months
Secondary outcome [2] 0 0
Disease Control Rate (DCR) according to the RECIST v1.1
Timepoint [2] 0 0
Up to 24 months
Secondary outcome [3] 0 0
Progression-free Survival (PFS)
Timepoint [3] 0 0
Up to 24 months
Secondary outcome [4] 0 0
Time to Treatment Response (TTR)
Timepoint [4] 0 0
Up to 24 months
Secondary outcome [5] 0 0
Duration of Response (DoR)
Timepoint [5] 0 0
Up to 24 months
Secondary outcome [6] 0 0
Overall Survival (OS)
Timepoint [6] 0 0
Up to 24 months
Secondary outcome [7] 0 0
Concentration of anti-drug antibodies (ADA)
Timepoint [7] 0 0
Up to 24 months
Secondary outcome [8] 0 0
Maximum observed concentration (C[max])
Timepoint [8] 0 0
Up to 24 months
Secondary outcome [9] 0 0
Area under the curve (AUC)
Timepoint [9] 0 0
Up to 24 months
Secondary outcome [10] 0 0
Terminal half-life (t[1/2])
Timepoint [10] 0 0
Up to 24 months
Secondary outcome [11] 0 0
Time to maximum concentration (Tmax)
Timepoint [11] 0 0
Up to 24 months

Eligibility
Key inclusion criteria
Key

- 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/10/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Chris O'Brien Lifehouse - Sydney
Recruitment hospital [2] 0 0
ICON Cancer Centre - Brisbane
Recruitment hospital [3] 0 0
Mater Cancer Care Centre - South Brisbane
Recruitment hospital [4] 0 0
Cancer Research SA - Adelaide
Recruitment hospital [5] 0 0
Cabrini Malvern Hospital - Malvern
Recruitment hospital [6] 0 0
One Clinical Research (OCR) - Perth
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
- Brisbane
Recruitment postcode(s) [3] 0 0
- South Brisbane
Recruitment postcode(s) [4] 0 0
- Adelaide
Recruitment postcode(s) [5] 0 0
- Malvern
Recruitment postcode(s) [6] 0 0
- Perth
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Fujian
Country [2] 0 0
China
State/province [2] 0 0
Hunan
Country [3] 0 0
China
State/province [3] 0 0
Shanghai

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Multitude Therapeutics Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Tigermed Consulting Co., Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05498597
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sarwan Bishnoi
Address 0 0
Cancer Research SA
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jane Zhu
Address 0 0
Country 0 0
Phone 0 0
13917933915
Fax 0 0
Email 0 0
juanjuan.zhu@multitudetherapeutics.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05498597