Evaluating AMT-116 for patients with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Mary Crowley Cancer Research Centers
  Dallas, Texas, United States 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

Study contacts

• Principal investigator: Jermaine Coward — Integrated Haematology and Oncology Network
• Study coordinator: Juanjuan Zhu
• Email: juanjuan.zhu@multitudetherapeutics.com
• Phone: +86 13917933915

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.