NCT05725291 AMT-116 in Patients With Advanced Solid Tumors
| NCT ID | NCT05725291 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Multitude Therapeutics Inc. |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-07-25 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 80 participants in total. It began in 2023-07-25 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
Jermaine Coward
PRINCIPAL INVESTIGATOR
Integrated Haematology and Oncology Network
Frequently Asked Questions
Who can join the NCT05725291 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05725291 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05725291 currently recruiting?
Yes, NCT05725291 is actively recruiting participants. Contact the research team at juanjuan.zhu@multitudetherapeutics.com for enrollment information.
Where is the NCT05725291 trial being conducted?
This trial is being conducted at Denver, United States, Dallas, United States, San Francisco, American Samoa, Cary, American Samoa and 6 additional locations.
Who is sponsoring the NCT05725291 clinical trial?
NCT05725291 is sponsored by Multitude Therapeutics Inc.. The principal investigator is Jermaine Coward at Integrated Haematology and Oncology Network. The trial plans to enroll 80 participants.