AMT-562 in Patients With Selected Advanced Solid Tumors

July 24, 2024 updated by: Multitude Therapeutics (Australia) Pty Ltd

First-in-Human, Phase 1 Study of AMT-562 in Patients With Advanced Solid Tumors

This is a first-in-human, non-randomized, open-label, multicenter Phase 1 study of AMT-562 in patients with advanced solid tumors.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • North Ryde, New South Wales, Australia
        • Recruiting
        • Macquarie University Hospital
        • Contact:
          • Dhanusha Sabanathan
    • Victoria
      • Malvern, Victoria, Australia
        • Recruiting
        • Cabrini Malvern Hospital
        • Contact:
          • Prachi Bhave

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. Patients must be willing and able to understand and 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 histologically confirmed unresectable advanced solid tumor.
  • 4. Patients who have undergone at least one systemic therapy and have radiologically or clinically determined progressive disease (PD) 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), defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally postmenopausal for at least 12 consecutive months (i.e., who has had menses any time in the preceding 12 consecutive months) must agree to use two effective contraceptive methods while on study treatment and for at least twelve weeks after the last dose of the IMP.
  • 10. WCBP must have a negative serum pregnancy test within 7 days prior to first dose of the IMP.
  • 11. Male patients must agree to use a latex condom, even if they had a successful vasectomy, while on study treatment and for at least twelve weeks after the last dose of the IMP.
  • 12. 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.
  • 13. Availability of tumor tissue sample (either an archival specimen or a fresh biopsy material) at screening.

Exclusion Criteria:

  • 1. Central nervous system (CNS) metastasis.
  • 2. Active or chronic skin disorder requiring systemic therapy.
  • 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 or 21 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 within 28 days.
  • 7. Major surgery within 28 days prior to first dose of the IMP, or no recovery from side effects of such intervention.
  • 8. Significant cardiac disease.
  • 9. Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis t.
  • 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 3A 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1
AMT-562 Dose Escalation
Drug: AMT-562
Administered AMT-562 for injection intravenously

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
DLTs
Time Frame: up to 24 month
Incidence of dose limiting toxicities
up to 24 month
AEs
Time Frame: up to 24 month
Type, incidence and severity of Adverse Events
up to 24 month
SAEs
Time Frame: up to 24 month
Type, incidence and severity Serious Adverse Events (SAEs)
up to 24 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Tmax
Time Frame: up to 24 month
time to peak drug concentration
up to 24 month
AUC
Time Frame: up to 24 month
Area Under the Curve
up to 24 month
t1/2
Time Frame: up to 24 month
terminal half-life of the ADC, total antibody and free payload
up to 24 month
ADAs
Time Frame: up to 24 month
Specification and quantification of anti-drug antibodies
up to 24 month
ORR
Time Frame: up to 24 month
Overall response rate assessed by the investigator according to RECIST version 1.1
up to 24 month
DCR
Time Frame: up to 24 month
Disease control rate assessed by the investigator according to RECIST version 1.1
up to 24 month
PFS
Time Frame: up to 24 month
Progression-free survival assessed by the investigator according to RECIST version 1.1
up to 24 month
TTR
Time Frame: up to 24 month
Time to response assessed by the investigator according to RECIST version 1.1
up to 24 month
DOR
Time Frame: up to 24 month
Duration of response assessed by the investigator according to RECIST version 1.1
up to 24 month
Cmax
Time Frame: up to 24 month
Maximum concentration (Cmax)
up to 24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Multitude Therapeutics (Australia) Pty Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 10, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AMT-562-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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