AMT-151 in Patients With Selected Advanced Solid Tumours

Last updated: October 17, 2023
Sponsor: Multitude Therapeutics Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Pancreatic Cancer

Pelvic Cancer

Metastatic Cancer

Treatment

AMT-151

Clinical Study ID

NCT05498597
AMT-151-01
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Patients must be willing and able to sign the Informed Consent Form, and to adhere tothe 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 haveradiologically or clinically determined progressive disease during or after their mostrecent line of therapy, and for whom no further standard therapy is available, or whoare intolerable to standard therapy.
  • Patients must have at least one measurable or non-measurable lesion as per RECISTversion 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 biopsymaterial) at screening.

Exclusion

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 isshorter, 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 focalradiation for analgesic purpose or for lytic lesions at risk of fracture within 14days prior to the first dose of the study drug, or no recovery from side effects ofsuch 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 sideeffects 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 ofthe study drug, acute and/or clinically significant bacterial, fungal, or viralinfection.
  • Pregnant or breast-feeding females. Note: Other protocol defined Inclusion/Exclusion criteria apply.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: AMT-151
Phase: 1
Study Start date:
January 25, 2023
Estimated Completion Date:
October 30, 2024

Connect with a study center

  • Chris O'Brien Lifehouse

    Sydney, New South Wales
    Australia

    Active - Recruiting

  • ICON Cancer Centre

    Brisbane, Queensland
    Australia

    Active - Recruiting

  • Mater Cancer Care Centre

    South Brisbane, Queensland
    Australia

    Active - Recruiting

  • Cancer Research SA

    Adelaide, South Australia
    Australia

    Active - Recruiting

  • Cabrini Malvern Hospital

    Malvern, Victoria
    Australia

    Active - Recruiting

  • One Clinical Research (OCR)

    Perth, Western Australia
    Australia

    Active - Recruiting

  • Fujian Provincial Cancer Hospital

    Fuzhou, Fujian 350014
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha, Hunan 410031
    China

    Site Not Available

  • Shanghai Tumor Hospital

    Shanghai, Shanghai 200032
    China

    Site Not Available

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