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
Qualifiers
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
Treatments tested in this trial
- AMT-116
Treatment groups
80 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov