Advanced Solid TumorPhase 1NCT05498597
AMT-151 in Patients With Selected Advanced Solid Tumours
A Phase 1 study testing AMT-151 in people with Advanced Solid Tumor and Advanced Cancer, run by Multitude Therapeutics Inc. at 9 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Advanced Cancer, Advanced Carcinoma
- What is being tested?
- AMT-151
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 25 Jan 2023to 30 Oct 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Serous, endometrioid, clear-cell, or mucinous epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
- Serous, endometrioid, or clear-cell endometrial cancer.
- Adenocarcinoma of the lung.
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- Triple-negative breast cancer.
- Pancreatic ductal adenocarcinoma.
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Australia6 sites, 6 recruiting
- Recruiting
Cancer Research SA
Adelaide, South Australia
Sarwan Bishnoi, 61 08 3592 565
- Recruiting
ICON Cancer Centre
Brisbane, Queensland
Jermaine Coward
- Recruiting
Cabrini Malvern Hospital
Malvern, Victoria
Richardson Gary, 61 03 9508 9542
- Recruiting
One Clinical Research (OCR)
Perth, Western Australia
Mihitha Ariyapperuma, 61 08 6279 9466
- Recruiting
Mater Cancer Care Centre
South Brisbane, Queensland
Catherine Shannon
- Recruiting
Chris O'Brien Lifehouse
Sydney, New South Wales
Steven Kao, 61 02 8514 0140
China3 sites, 3 recruiting
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410031
Jing Wang, Director, 13875902083, wangjing0081@126.com
- Not yet recruiting
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350014
An Lin, Director
- Not yet recruiting
Shanghai Tumor Hospital
Shanghai, Shanghai Municipality, 200032
Jian Zhang, Director, 02164175590, syner2000@163.com
Xiaohua Wu, Director, 15618369676, edison-1016@163.com
About this study
Official 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
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.
- Conditions
- Advanced Solid Tumor, Advanced Cancer, Advanced Carcinoma, Ovarian Cancer, Ovarian Carcinoma, Ovarian Epithelial Cancer
- Being tested
- AMT-151
- Keywords
- Carcinoma, Cancer, Antibody-Drug Conjugate, Folate Receptor Alpha
- Medical subject headings
- Ovarian Neoplasms, Carcinoma, Ovarian Epithelial, Endometrial Neoplasms, Adenocarcinoma of Lung, Triple Negative Breast Neoplasms, Mesothelioma, Malignant, Carcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMT-151Drug
Administered intravenously
| Study group | Role | What they receive |
|---|---|---|
| AMT-151 Dose Escalation | Experimental | Not described Receives: Drug: AMT-151 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase 2 Dose (RP2D)
The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data
Measured: Up to 24 months
Maximum Tolerated Dose (MTD)
The MTD will be determined using DLTs
Measured: Up to 24 months
Incidence of Adverse Events
Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.0
Measured: Up to 24 months
Secondary outcomes (11)
Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
Proportion of patients achieving Complete Response (CR) or Partial Response (PR)
Measured: Up to 24 months
Disease Control Rate (DCR) according to the RECIST v1.1
Proportion of patients achieving CR, PR or Stable Disease (SD)
Measured: Up to 24 months
Progression-free Survival (PFS)
Time from date of start of treatment to date of the first progression or death, whichever occurs first.
Measured: Up to 24 months
Time to Treatment Response (TTR)
Time from date of start of treatment to date of the first assessment of response (PR or CR)
Measured: Up to 24 months
Duration of Response (DoR)
Time from date of first assessment of response (CR or PR) to date of the first progression or death, whichever occurs first
Measured: Up to 24 months
Overall Survival (OS)
Time from date of start of treatment to date of death
Measured: Up to 24 months
Concentration of anti-drug antibodies (ADA)
Immunogenicity profile characterized by concentration of ADAs
Measured: Up to 24 months
Maximum observed concentration (C[max])
Pharmacokinetic profile characterized by the maximum observed concentration (C[max]) of AMT-151
Measured: Up to 24 months
Area under the curve (AUC)
Pharmacokinetic profile characterized by the area under the curve (AUC) of AMT-151
Measured: Up to 24 months
Terminal half-life (t[1/2])
Pharmacokinetic profile characterized by the terminal half-life (t[1/2]) of AMT-151
Measured: Up to 24 months
Time to maximum concentration (Tmax)
Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) of AMT-151
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start25 Jan 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion30 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Multitude Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Sarwan Bishnoi, Principal investigator, Cancer Research SARichardson Gary, Principal investigator, Cabrini Malvern HospitalSteven Kao, Principal investigator, Chris O'Brien LifehouseCatherine Shannon, Principal investigator, Mater Cancer Care CentreJermaine Coward, Principal investigator, Integrated Haematology and Oncology NetworkMihitha Ariyapperuma, Principal investigator, One Clinical Research (OCR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498597
- Sponsor's protocol ID
- AMT-151-01
- Status last verified
- Oct 2023
- First submitted
- 10 Aug 2022
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT05498597
- Acronym / sponsor ID
- AMT-151-01
- Conditions
- Advanced Solid Tumor, Advanced Cancer, Advanced Carcinoma, Ovarian Cancer, Ovarian Carcinoma, Ovarian Epithelial Cancer
- Keywords
- Carcinoma, Cancer, Antibody-Drug Conjugate, Folate Receptor Alpha
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Multitude Therapeutics Inc.Industry (pharma, biotech, devices)
- Collaborators
- Tigermed Consulting Co., Ltd
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 12 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMT-151 Dose Escalation | Experimental | Drug: AMT-151 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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:
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMT-151Administered intravenously | Drug | AMT-151 Dose Escalation |
Primary outcome
Recommended Phase 2 Dose (RP2D)
Time frame: Up to 24 months
The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data
Maximum Tolerated Dose (MTD)
Time frame: Up to 24 months
The MTD will be determined using DLTs
Incidence of Adverse Events
Time frame: Up to 24 months
Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.0
11 secondary outcomes
Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
Time frame: Up to 24 months
Disease Control Rate (DCR) according to the RECIST v1.1
Time frame: Up to 24 months
Progression-free Survival (PFS)
Time frame: Up to 24 months
Time to Treatment Response (TTR)
Time frame: Up to 24 months
Duration of Response (DoR)
Time frame: Up to 24 months
Overall Survival (OS)
Time frame: Up to 24 months
Concentration of anti-drug antibodies (ADA)
Time frame: Up to 24 months
Maximum observed concentration (C[max])
Time frame: Up to 24 months
Area under the curve (AUC)
Time frame: Up to 24 months
Terminal half-life (t[1/2])
Time frame: Up to 24 months
Time to maximum concentration (Tmax)
Time frame: Up to 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarwan Bishnoi principal investigator
Cancer Research SA
Richardson Gary principal investigator
Cabrini Malvern Hospital
Steven Kao principal investigator
Chris O'Brien Lifehouse
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMT-151 in people with Advanced Solid Tumor and Advanced Cancer, run by Multitude Therapeutics Inc. at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Australia, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jane Zhu (13917933915, juanjuan.zhu@multitudetherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recommended Phase 2 Dose (RP2D) (time frame: Up to 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.