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AMT-151 in Patients With Selected Advanced Solid Tumours

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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
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 Drug: AMT-151 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 25, 2023
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : October 30, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: AMT-151 Dose Escalation Drug: AMT-151
Administered intravenously


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Maximum Tolerated Dose (MTD) [ Time Frame: Up to 24 months ]
    The MTD will be determined using DLTs

  3. 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


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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.

  4. 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)

  5. 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

  6. Overall Survival (OS) [ Time Frame: Up to 24 months ]
    Time from date of start of treatment to date of death

  7. Concentration of anti-drug antibodies (ADA) [ Time Frame: Up to 24 months ]
    Immunogenicity profile characterized by concentration of ADAs

  8. Maximum observed concentration (C[max]) [ Time Frame: Up to 24 months ]
    Pharmacokinetic profile characterized by the maximum observed concentration (C[max]) of AMT-151

  9. Area under the curve (AUC) [ Time Frame: Up to 24 months ]
    Pharmacokinetic profile characterized by the area under the curve (AUC) of AMT-151

  10. 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

  11. Time to maximum concentration (Tmax) [ Time Frame: Up to 24 months ]
    Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) of AMT-151


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05498597


Contacts
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Contact: Jane Zhu 13917933915 juanjuan.zhu@multitudetherapeutics.com

Locations
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Australia, New South Wales
Chris O'Brien Lifehouse Recruiting
Sydney, New South Wales, Australia
Contact: Steven Kao    61 02 8514 0140      
Australia, Queensland
ICON Cancer Centre Recruiting
Brisbane, Queensland, Australia
Contact: Jermaine Coward         
Mater Cancer Care Centre Recruiting
South Brisbane, Queensland, Australia
Contact: Catherine Shannon         
Australia, South Australia
Cancer Research SA Recruiting
Adelaide, South Australia, Australia
Contact: Sarwan Bishnoi    61 08 3592 565      
Australia, Victoria
Cabrini Malvern Hospital Recruiting
Malvern, Victoria, Australia
Contact: Richardson Gary    61 03 9508 9542      
Australia, Western Australia
One Clinical Research (OCR) Recruiting
Perth, Western Australia, Australia
Contact: Mihitha Ariyapperuma    61 08 6279 9466      
China, Fujian
Fujian Provincial Cancer Hospital Not yet recruiting
Fuzhou, Fujian, China, 350014
Contact: An Lin, Director         
China, Hunan
Hunan Cancer Hospital Not yet recruiting
Changsha, Hunan, China, 410031
Contact: Jing Wang, Director    13875902083    wangjing0081@126.com   
China, Shanghai
Shanghai Tumor Hospital Not yet recruiting
Shanghai, Shanghai, China, 200032
Contact: Jian Zhang, Director    02164175590    syner2000@163.com   
Contact: Xiaohua Wu, Director    15618369676    edison-1016@163.com   
Sponsors and Collaborators
Multitude Therapeutics Inc.
Tigermed Consulting Co., Ltd
Investigators
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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)
More Information
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Responsible Party: Multitude Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT05498597    
Other Study ID Numbers: AMT-151-01
First Posted: August 12, 2022    Key Record Dates
Last Update Posted: October 19, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Multitude Therapeutics Inc.:
Carcinoma
Cancer
Antibody-Drug Conjugate
Folate Receptor Alpha
Additional relevant MeSH terms:
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Carcinoma
Adenocarcinoma
Endometrial Neoplasms
Triple Negative Breast Neoplasms
Mesothelioma
Mesothelioma, Malignant
Carcinoma, Ovarian Epithelial
Adenocarcinoma of Lung
Cystadenocarcinoma, Serous
Carcinoma, Endometrioid
Adenocarcinoma, Clear Cell
Adenocarcinoma, Mucinous
Cystadenocarcinoma
Adenomyoepithelioma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases
Endocrine System Diseases