Evaluating AMT-116 for patients with advanced solid tumors

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

This study is testing a new treatment called AMT-116 to see if it can safely help people with advanced solid tumors that haven’t responded to other therapies.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Multitude Therapeutics Inc. (industry)
• Drugs / interventions: radiation
• Locations: 10 sites (Denver, Colorado and 9 other locations)
• Trial ID: NCT05725291 on ClinicalTrials.gov

What this trial studies

This first-in-human trial aims to assess the safety, tolerability, and anti-tumor activity of AMT-116 in patients with advanced solid tumors. The study will determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) while also evaluating pharmacokinetics and pharmacodynamics. Eligible participants must have histologically confirmed unresectable tumors and have experienced disease progression after standard therapies. The trial will involve multiple research sites to gather comprehensive data on the treatment's effectiveness.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with unresectable advanced solid tumors who have progressed after standard therapies.

Not a fit: Patients with resectable tumors or those who have not yet undergone systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.

How similar studies have performed: While this approach is novel, similar studies targeting advanced solid tumors have shown promise in evaluating new therapies.

Eligibility criteria

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.

Where this trial is running

Denver, Colorado and 9 other locations

• Sarah Cannon Research Institute — Denver, Colorado, United States (NOT_YET_RECRUITING)
• Mary Crowley Cancer Research Centers — Dallas, Texas, United States (RECRUITING)
• University of California San Francisco Cancer Center — San Francisco, California, American Samoa (NOT_YET_RECRUITING)
• Carolina BioOncology Institute, LLC — Cary, North Carolina, American Samoa (RECRUITING)
• Macquarie University Hospital — Sydney, New South Wales, Australia (RECRUITING)
• ICON Cancer Centre — Brisbane, Queensland, Australia (RECRUITING)
• Southern Oncology Clinical Research Unit — Adelaide, South Australia, Australia (RECRUITING)
• Alfred Hospital — Victoria Park, Victoria, Australia (RECRUITING)
• Austin Health — Victoria Park, Victoria, Australia (RECRUITING)
• Cabrini Hospital — Victoria Park, Victoria, Australia (RECRUITING)

Study contacts

• Principal investigator: Jermaine Coward — Integrated Haematology and Oncology Network
• Study coordinator: Juanjuan Zhu

Conditions: Advanced Solid Tumor