AMT-151 in Patients With Selected Advanced Solid Tumours

October 17, 2023 updated by: Multitude Therapeutics Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • 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 Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia
        • Recruiting
        • Chris O'Brien Lifehouse
        • Contact:
          • Steven Kao
          • Phone Number: 61 02 8514 0140
    • Queensland
      • Brisbane, Queensland, Australia
        • Recruiting
        • Icon Cancer Centre
        • Contact:
          • Jermaine Coward
      • South Brisbane, Queensland, Australia
        • Recruiting
        • Mater Cancer Care Centre
        • Contact:
          • Catherine Shannon
    • South Australia
      • Adelaide, South Australia, Australia
        • Recruiting
        • Cancer Research Sa
        • Contact:
          • Sarwan Bishnoi
          • Phone Number: 61 08 3592 565
    • Victoria
      • Malvern, Victoria, Australia
        • Recruiting
        • Cabrini Malvern Hospital
        • Contact:
          • Richardson Gary
          • Phone Number: 61 03 9508 9542
    • Western Australia
      • Perth, Western Australia, Australia
        • Recruiting
        • One Clinical Research (OCR)
        • Contact:
          • Mihitha Ariyapperuma
          • Phone Number: 61 08 6279 9466
  • China
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Not yet recruiting
        • Fujian Provincial Cancer Hospital
        • Contact:
          • An Lin, Director
    • Hunan
      • Changsha, Hunan, China, 410031
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Not yet recruiting
        • Shanghai Tumor Hospital
        • Contact:
        • Contact:

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

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
Intervention / Treatment
Experimental: AMT-151 Dose Escalation
Drug: AMT-151
Administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 24 months
Maximum Tolerated Dose (MTD)
Time Frame: Up to 24 months
The MTD will be determined using DLTs
Up to 24 months
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
Up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumours (RECIST) v1.1
Time Frame: Up to 24 months
Proportion of patients achieving Complete Response (CR) or Partial Response (PR)
Up to 24 months
Disease Control Rate (DCR) according to the RECIST v1.1
Time Frame: Up to 24 months
Proportion of patients achieving CR, PR or Stable Disease (SD)
Up to 24 months
Progression-free Survival (PFS)
Time Frame: Up to 24 months
Time from date of start of treatment to date of the first progression or death, whichever occurs first.
Up to 24 months
Time to Treatment Response (TTR)
Time Frame: Up to 24 months
Time from date of start of treatment to date of the first assessment of response (PR or CR)
Up to 24 months
Duration of Response (DoR)
Time Frame: Up to 24 months
Time from date of first assessment of response (CR or PR) to date of the first progression or death, whichever occurs first
Up to 24 months
Overall Survival (OS)
Time Frame: Up to 24 months
Time from date of start of treatment to date of death
Up to 24 months
Concentration of anti-drug antibodies (ADA)
Time Frame: Up to 24 months
Immunogenicity profile characterized by concentration of ADAs
Up to 24 months
Maximum observed concentration (C[max])
Time Frame: Up to 24 months
Pharmacokinetic profile characterized by the maximum observed concentration (C[max]) of AMT-151
Up to 24 months
Area under the curve (AUC)
Time Frame: Up to 24 months
Pharmacokinetic profile characterized by the area under the curve (AUC) of AMT-151
Up to 24 months
Terminal half-life (t[1/2])
Time Frame: Up to 24 months
Pharmacokinetic profile characterized by the terminal half-life (t[1/2]) of AMT-151
Up to 24 months
Time to maximum concentration (Tmax)
Time Frame: Up to 24 months
Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) of AMT-151
Up to 24 months

Collaborators and Investigators

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

Sponsor

Multitude Therapeutics Inc.

Collaborators

Tigermed Consulting Co., Ltd

Investigators

  • Principal Investigator: Sarwan Bishnoi, Cancer Research Sa
  • Principal Investigator: Richardson Gary, Cabrini Malvern Hospital
  • Principal Investigator: Steven Kao, Chris O'Brien Lifehouse
  • Principal Investigator: Catherine Shannon, Mater Cancer Care Centre
  • Principal Investigator: Mihitha Ariyapperuma, One Clinical Research (OCR)
  • Principal Investigator: Jermaine Coward, Icon Cancer Centre

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)

January 25, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

August 10, 2022

First Submitted That Met QC Criteria

August 10, 2022

First Posted (Actual)

August 12, 2022

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMT-151-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Ovarian Cancer

Clinical Trials on AMT-151

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bulgaria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe