AMT-116 in Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMultitude Therapeutics Inc.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
AMT-116
DrugAdministered intravenously
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: AMT-116 Dose EscalationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Recommended Phase 2 Dose (RP2D)
The RP2D will be determined using dose limiting toxicities (DLTs) and all other available study data
Time frame
Up to 24 months2
Maximum Tolerated Dose (MTD)
The MTD will be determined using DLTs
Time frame
Up to 24 months3
Type, incidence and severity of Adverse Events
Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.0
Time frame
Up to 24 monthsSecondary outcomes
1
Overall Response Rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Proportion of patients achieving Complete Response (CR) or Partial Response (PR)
Time frame
Up to 24 months2
Disease Control Rate (DCR) according to the RECIST v1.1
Proportion of patients achieving CR, PR or Stable Disease (SD)
Time frame
Up to 24 months3
Progression-free Survival (PFS)
Time from date of start of treatment to date of the first progression or death, whichever occurs first.
Time frame
Up to 24 months4
Concentration of anti-drug antibodies (ADA)
Immunogenicity profile characterized by concentration of ADAs
Time frame
Up to 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov