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AMT-116 for Advanced Solid Tumors

This study is testing a new drug called AMT-116 in people with advanced solid tumors that cannot be removed by surgery. The main goals are to find the safest and most effective dose of AMT-116, understand its side effects, and see if it can shrink tumors. You may be able to join if you are at least 18 years old and have certain types of advanced solid tumors, such as head and neck, non-small cell lung, or colorectal cancer. The study is currently recruiting participants, with a plan to enroll 80 people.

Study design
This is a first-in-human study, meaning it's the first time AMT-116 is being tested in people. It aims to enroll 80 participants.
What's involved
You would need to sign a consent form and follow the study visit schedule and other requirements.
Compensation
Not stated in the trial record.
Follow-up
The study will track side effects and dose information for up to 24 months.

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NCT05725291

AMT-116 in Patients With Advanced Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
Multitude Therapeutics Inc.
~80 participants
Updated 2025-08-17 on ClinicalTrials.gov
What's tested:AMT-116

At a glance

Recruiting sites
8 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recommended Phase 2 Dose (RP2D)
Measured over Up to 24 months
+2 more outcomes measured

Conditions

Advanced Solid Tumor

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Basal Cell CarcinomaBladder CarcinomaBreast CarcinomaCervical CarcinomaColorectal CarcinomaEsophageal CarcinomaGastric CarcinomaLarge Cell Lung CancerLiver CarcinomaLung Non-Small Cell CarcinomaMalignant Head and Neck NeoplasmMalignant neoplasm of biliary tractPancreatic CarcinomaSkin Squamous Cell CarcinomaSolid Neoplasm

Where it's being run

10 sites across 8 states
Victoria3
Colorado1
Texas1
California1
North Carolina1
New South Wales1
Queensland1
South Australia1

Study leadership

  • Jermaine Coward · PRINCIPAL_INVESTIGATOR · Integrated Haematology and Oncology Network

Who to contact

Juanjuan Zhu
[email protected]
+86 13917933915
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.

What this trial measures

  • 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

  • Maximum Tolerated Dose (MTD)Up to 24 months

    The MTD will be determined using DLTs

  • Type, incidence and severity of Adverse EventsUp to 24 months

    Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.0