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Trial record 1 of 1 for:    AMT116-01
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AMT-116 in Patients With Advanced Solid Tumors

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. Identifier: NCT05725291
Recruitment Status : Recruiting
First Posted : February 13, 2023
Last Update Posted : July 27, 2023
Information provided by (Responsible Party):
Multitude Therapeutics Inc.

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-116, in Patients with Advanced Solid Tumors

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: AMT-116 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 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-116 in Patients With Advanced Solid Tumors
Actual Study Start Date : June 28, 2023
Estimated Primary Completion Date : January 30, 2025
Estimated Study Completion Date : July 30, 2025

Arm Intervention/treatment
Experimental: AMT-116 Dose Escalation Drug: AMT-116
Administered intravenously

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. Type, incidence and severity 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 Tumors (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. Concentration of anti-drug antibodies (ADA) [ Time Frame: Up to 24 months ]
    Immunogenicity profile characterized by concentration of ADAs

  5. Maximum observed concentration (C[max]) [ Time Frame: Up to 24 months ]
    Pharmacokinetic profile characterized by the maximum observed concentration (C[max]) of AMT-116

  6. Area under the curve (AUC) [ Time Frame: Up to 24 months ]
    Pharmacokinetic profile characterized by the area under the curve (AUC) of AMT-116

  7. 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-116

  8. Time to maximum concentration (Tmax) [ Time Frame: Up to 24 months ]
    Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) of AMT-116

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Key Inclusion Criteria:

  • Patients must be willing and able to sign the ICF, and to adhere to the study visit schedule and other protocol requirements.
  • Age ≥18 years (at the time consent is obtained).
  • Patients with histologically confirmed, unresectable advanced solid tumor. Preferred tumor types include head and neck, non-small cell lung, esophageal, pancreatic, large cell lung, colorectal, cervical, breast, bladder, gastric, biliary tract, skin squamous cell, liver, and basal cell cancer.
  • Patients who have undergone at least one systemic therapy and have radiologically or clinically determined progressive disease during or after 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 lesion as per RECIST version 1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • Both male and female patients must agree to use effective contraceptive methods.
  • Patients must have adequate organ function.
  • Women of child-bearing potential (WCBP) must have a negative serum pregnancy test.
  • Male patients must agree to use a latex condom, even if they had a successful vasectomy, while on study treatment and for at least 12 weeks after the last dose of the IMP.
  • Male patients must agree not to donate sperm, and female patients must agree not to donate eggs, while on study treatment and for at least 12 weeks after the last dose of the IMP.
  • Availability of tumour tissue sample (either an archival specimen or a fresh biopsy material) at screening.

Key Exclusion Criteria:

  • Prior therapy with ADC based on Top1 inhibitor.
  • Central nervous system (CNS) metastasis.
  • Active or chronic skin disorder requiring systemic therapy.
  • History of Steven's Johnson's syndrome or Toxic Epidermal Necrolysis syndrome.
  • Active ocular conditions requiring treatment or close monitoring, including, but not limited to: macular degeneration, papilledema, active diabetic retinopathy with macular oedema, wet age-related macular degeneration requiring intravitreal injections, or uncontrolled glaucoma.
  • 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 first dose of the IMP.
  • Radiotherapy to lung field at a total radiation dose of ≥20 Gy within 6 months, wide-field radiotherapy (e.g., > 30% of marrow-bearing bones) within 28 days.
  • Major surgery (not including placement of vascular access device or tumor biopsies) within 28 days prior to the first dose of the IMP, or no recovery from side effects of such intervention.
  • Prior allogeneic or autologous bone marrow transplantation.
  • Significant cardiac disease, such as recent (within six months prior to first dose of the IMP) myocardial infarction or acute coronary syndromes (including unstable angina pectoris), congestive heart failure (New York Heart Association class III or IV), uncontrolled hypertension, uncontrolled cardiac arrhythmias.
  • Pregnant or breast-feeding females.

Note: Other protocol defined Inclusion/Exclusion criteria apply.

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 identifier (NCT number): NCT05725291

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Contact: Shuang Leng +61 411818616

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Australia, Queensland
ICON Cancer Centre Recruiting
Brisbane, Queensland, Australia
Contact: Jermaine Coward         
Sponsors and Collaborators
Multitude Therapeutics Inc.
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Principal Investigator: Jermaine Coward ICON Cancer Centre
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Responsible Party: Multitude Therapeutics Inc. Identifier: NCT05725291    
Other Study ID Numbers: AMT-116-01
First Posted: February 13, 2023    Key Record Dates
Last Update Posted: July 27, 2023
Last Verified: July 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
Additional relevant MeSH terms:
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