AMT-151 in Patients With Selected Advanced Solid Tumours

Sponsor
Multitude Therapeutics Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05498597
Collaborator
Tigermed Consulting Co., Ltd (Industry)
30
1
25

Study Details

Study Description

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.

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Oct 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: AMT-151 Dose Escalation

Drug: AMT-151
Administered intravenously

Outcome Measures

Primary Outcome Measures

  1. Recommended Phase 2 Dose (RP2D) [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) [Up to 24 months]

    The MTD will be determined using DLTs

  3. Incidence of Adverse Events [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 [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 [Up to 24 months]

    Proportion of patients achieving CR, PR or Stable Disease (SD)

  3. Progression-free Survival (PFS) [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) [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) [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) [Up to 24 months]

    Time from date of start of treatment to date of death

  7. Concentration of anti-drug antibodies (ADA) [Up to 24 months]

    Immunogenicity profile characterized by concentration of ADAs

  8. Maximum observed concentration (C[max]) [Up to 24 months]

    Pharmacokinetic profile characterized by the maximum observed concentration (C[max]) of AMT-151

  9. Area under the curve (AUC) [Up to 24 months]

    Pharmacokinetic profile characterized by the area under the curve (AUC) of AMT-151

  10. Terminal half-life (t[1/2]) [Up to 24 months]

    Pharmacokinetic profile characterized by the terminal half-life (t[1/2]) of AMT-151

  11. Time to maximum concentration (Tmax) [Up to 24 months]

    Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) of AMT-151

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Multitude Therapeutics Inc.
  • Tigermed Consulting Co., Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Multitude Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT05498597
Other Study ID Numbers:
  • AMT-151-01
First Posted:
Aug 12, 2022
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Multitude Therapeutics Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 12, 2022