The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

AMT-151 in Patients With Selected Advanced Solid Tumours

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05498597
Recruitment Status : Recruiting
First Posted : August 12, 2022
Last Update Posted : October 19, 2023
Sponsor:
Collaborator:
Tigermed Consulting Co., Ltd
Information provided by (Responsible Party):
Multitude Therapeutics Inc.

Tracking Information
First Submitted Date  ICMJE August 10, 2022
First Posted Date  ICMJE August 12, 2022
Last Update Posted Date October 19, 2023
Actual Study Start Date  ICMJE January 25, 2023
Estimated Primary Completion Date January 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2022)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2022)
  • 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)
  • 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)
  • 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.
  • 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)
  • 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
  • Overall Survival (OS) [ Time Frame: Up to 24 months ]
    Time from date of start of treatment to date of death
  • Concentration of anti-drug antibodies (ADA) [ Time Frame: Up to 24 months ]
    Immunogenicity profile characterized by concentration of ADAs
  • Maximum observed concentration (C[max]) [ Time Frame: Up to 24 months ]
    Pharmacokinetic profile characterized by the maximum observed concentration (C[max]) of AMT-151
  • Area under the curve (AUC) [ Time Frame: Up to 24 months ]
    Pharmacokinetic profile characterized by the area under the curve (AUC) of AMT-151
  • 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
  • Time to maximum concentration (Tmax) [ Time Frame: Up to 24 months ]
    Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) of AMT-151
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AMT-151 in Patients With Selected Advanced Solid Tumours
Official Title  ICMJE First-in-Human, Phase 1 Study of AMT-151, an Anti-Folate Receptor Alpha Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE Drug: AMT-151
Administered intravenously
Study Arms  ICMJE Experimental: AMT-151 Dose Escalation
Intervention: Drug: AMT-151
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 10, 2022)		 30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 30, 2024
Estimated Primary Completion Date January 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jane Zhu 13917933915 juanjuan.zhu@multitudetherapeutics.com
Listed Location Countries  ICMJE Australia,   China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05498597
Other Study ID Numbers  ICMJE AMT-151-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Multitude Therapeutics Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Multitude Therapeutics Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Tigermed Consulting Co., Ltd
Investigators  ICMJE
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: Jermaine Coward ICON Cancer Centre
Principal Investigator: Mihitha Ariyapperuma One Clinical Research (OCR)
PRS Account Multitude Therapeutics Inc.
Verification Date October 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP