AMT-116 in Patients With Advanced Solid Tumors
- Registration Number
- NCT05725291
- Lead Sponsor
- Multitude Therapeutics Inc.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AMT-116 Dose Escalation AMT-116 -
- Primary Outcome Measures
Name Time Method 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 Events Up to 24 months Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.0
- Secondary Outcome Measures
Name Time Method Maximum observed concentration (C[max]) Up to 24 months Pharmacokinetic profile characterized by the maximum observed concentration (C\[max\]) of AMT-116
Area under the curve (AUC) Up to 24 months Pharmacokinetic profile characterized by the area under the curve (AUC) of AMT-116
Terminal half-life (t[1/2]) Up to 24 months Pharmacokinetic profile characterized by the terminal half-life (t\[1/2\]) of AMT-116
Concentration of anti-drug antibodies (ADA) Up to 24 months Immunogenicity profile characterized by concentration of ADAs
Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 Up to 24 months Proportion of patients achieving Complete Response (CR) or Partial Response (PR)
Disease Control Rate (DCR) according to the RECIST v1.1 Up to 24 months Proportion of patients achieving CR, PR or Stable Disease (SD)
Progression-free Survival (PFS) Up to 24 months Time from date of start of treatment to date of the first progression or death, whichever occurs first.
Time to maximum concentration (Tmax) Up to 24 months Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) of AMT-116
Trial Locations
- Locations (10)
Sarah Cannon Research Institute
🇺🇸Denver, Colorado, United States
Mary Crowley Cancer Research Centers
🇺🇸Dallas, Texas, United States
Carolina BioOncology Institute, LLC
🇦🇸Cary, American Samoa
University of California San Francisco Cancer Center
🇦🇸San Francisco, American Samoa
Macquarie University Hospital
🇦🇺Syd, New South Wales, Australia
ICON Cancer Centre
🇦🇺Brisbane, Queensland, Australia
Southern Oncology Clinical Research Unit
🇦🇺Adelaide, South Australia, Australia
Alfred Hospital
🇦🇺Victoria Park, Victoria, Australia
Austin Health
🇦🇺Victoria Park, Victoria, Australia
Cabrini Hospital
🇦🇺Victoria Park, Victoria, Australia