AMT-116 in Patients With Advanced Solid Tumors

Launched by MULTITUDE THERAPEUTICS INC. · Feb 2, 2023

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ClinConnect Summary

The AMT-116 clinical trial is studying a new treatment for patients with advanced solid tumors, which are cancers that cannot be surgically removed. This is a Phase 1 trial, meaning it’s the first time this treatment is being tested in humans. The researchers want to find out how much of the drug can be safely given, how well it works at treating tumors, and how the body processes it. This trial is currently looking for participants aged 18 and older who have specific types of cancer that have not responded to standard treatments.

To be eligible for this trial, patients need to have a confirmed diagnosis of an advanced solid tumor and must have already tried at least one other treatment that didn’t work. Participants will need to attend scheduled visits and provide a tissue sample from their tumor. If you join the study, you can expect to receive the new treatment under close medical supervision, with regular check-ups to monitor your health and the effect of the drug. It’s important to know that there are certain conditions that would exclude someone from participating, such as having specific heart issues or ongoing skin conditions. If you think you might be eligible, it’s a good idea to discuss this with your healthcare team.

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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.