AMT-116 in Patients With Advanced Solid Tumors

First-in-Human, Phase 1 Study of AMT-116 in Patients With Advanced Solid Tumors

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

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: AMT-116

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Juanjuan Zhu; Phone Number: +86 13917933915; Email: juanjuan.zhu@multitudetherapeutics.com

Study Locations

• American Samoa
  • Cary, American Samoa, 28078
    • Recruiting
    • Carolina BioOncology Institute, LLC
    • Contact: Powderly John
  • San Francisco, American Samoa, 94115
    • Not yet recruiting
    • University of California San Francisco Cancer Center
    • Contact: Munster Pamela
• Australia
  • New South Wales
    • Syd, New South Wales, Australia, 2109
      • Recruiting
      • Macquarie University Hospital
      • Contact: Park John
  • Queensland
    • Brisbane, Queensland, Australia
      • Recruiting
      • Icon Cancer Centre
      • Contact: Jermaine Coward
  • South Australia
    • Adelaide, South Australia, Australia, 5042
      • Recruiting
      • Southern Oncology Clinical Research Unit
      • Contact: Kichenadasse Ganessan
  • Victoria
    • Victoria Park, Victoria, Australia, 3004
      • Recruiting
      • Alfred Hospital
      • Contact: Voskoboynik Mark
    • Victoria Park, Victoria, Australia, 3084
      • Recruiting
      • Austin Health
      • Contact: Parakh Sagun
    • Victoria Park, Victoria, Australia, 3144
      • Recruiting
      • Cabrini Hospital
      • Contact: Richardson Gary
• United States
  • Colorado
    • Denver, Colorado, United States, 80218
      • Not yet recruiting
      • Sarah Cannon Research Institute
      • Contact: Perez Batista Cesar Augusto
  • Texas
    • Dallas, Texas, United States, 75230
      • Recruiting
      • Mary Crowley Cancer Research Centers
      • Contact: Orr Douglas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AMT-116 Dose Escalation	Drug: AMT-116; Administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recommended Phase 2 Dose (RP2D)	The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data	Up to 24 months
Maximum Tolerated Dose (MTD)	The MTD will be determined using DLTs	Up to 24 months
Type, incidence and severity of Adverse Events	Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.0	Up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Control Rate (DCR) according to the RECIST v1.1	Proportion of patients achieving CR, PR or Stable Disease (SD)	Up to 24 months
Progression-free Survival (PFS)	Time from date of start of treatment to date of the first progression or death, whichever occurs first.	Up to 24 months
Concentration of anti-drug antibodies (ADA)	Immunogenicity profile characterized by concentration of ADAs	Up to 24 months
Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1	Proportion of patients achieving Complete Response (CR) or Partial Response (PR)	Up to 24 months
Maximum observed concentration (C[max])	Pharmacokinetic profile characterized by the maximum observed concentration (C[max]) of AMT-116	Up to 24 months
Area under the curve (AUC)	Pharmacokinetic profile characterized by the area under the curve (AUC) of AMT-116	Up to 24 months
Terminal half-life (t[1/2])	Pharmacokinetic profile characterized by the terminal half-life (t[1/2]) of AMT-116	Up to 24 months
Time to maximum concentration (Tmax)	Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) of AMT-116	Up to 24 months

Collaborators and Investigators

• Sponsor: Multitude Therapeutics Inc.
• Investigators: Principal Investigator: Jermaine Coward, Icon Cancer Centre

Study record dates

Study Major Dates

• Study Start (Actual): July 25, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (Actual): February 13, 2023

Study Record Updates

• Last Update Posted (Actual): August 17, 2025
• Last Update Submitted That Met QC Criteria: August 13, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: AMT-116-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No