AMT-116 in Patients With Advanced Solid Tumors

NCT05725291 | Recruiting Phase 1 FDA Drug

• 1 other identifier: AMT-116-01
• Study Type: interventional
• Target: 80
• Locations: 3 countries
• Sites: 10

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

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

  Up to 24 months

• Disease Control Rate (DCR) according to the RECIST v1.1

  Up to 24 months

• Progression-free Survival (PFS)

  Up to 24 months

• Concentration of anti-drug antibodies (ADA)

  Up to 24 months

• Maximum observed concentration (C[max])

  Up to 24 months

Study Arms (1)

AMT-116 Dose Escalation

EXPERIMENTAL

Drug: AMT-116

Interventions

AMT-116 DRUG

Administered intravenously

AMT-116 Dose Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Multitude Therapeutics Inc.: lead

Study Sites (10)

Sarah Cannon Research Institute

Denver, Colorado, 80218, United States

NOT YET RECRUITING

Mary Crowley Cancer Research Centers

Dallas, Texas, 75230, United States

RECRUITING

University of California San Francisco Cancer Center

San Francisco, California, 94115, American Samoa

NOT YET RECRUITING

Carolina BioOncology Institute, LLC

Cary, North Carolina, 28078, American Samoa

RECRUITING

Macquarie University Hospital

Sydney, New South Wales, 2109, Australia

RECRUITING

ICON Cancer Centre

Brisbane, Queensland, Australia

RECRUITING

Southern Oncology Clinical Research Unit

Adelaide, South Australia, 5042, Australia

RECRUITING

Alfred Hospital

Victoria Park, Victoria, 3004, Australia

RECRUITING

Austin Health

Victoria Park, Victoria, 3084, Australia

RECRUITING

Cabrini Hospital

Victoria Park, Victoria, 3144, Australia

RECRUITING

Study Officials

• Jermaine Coward

  ICON Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juanjuan Zhu

CONTACT

+86 13917933915; juanjuan.zhu@multitudetherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 13, 2023
• Study Start: July 25, 2023
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AM (2); AU (6); US (2)