AMT-116 in Patients with Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMultitude Therapeutics Inc.
About this trial
The purpose of this study is to evaluate the safety and efficacy of AMT-116 monotherapy in subjects with advanced solid tumors. The study is divided into two parts: the part I is dose escalation and the Part Ⅱ for expansion.
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 non-small cell lung, head and neck, esophageal, 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
144 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov