AMT-253 in Patients With Advanced Solid Tumours
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMultitude Therapeutics Inc.
About this trial
This is a non-randomized, open-label, multicenter Phase I/II study of AMT-253 in patients with Unresectable or Metastatic Malignant Melanoma and other Advanced Solid Tumors. This study include phase I dose escalation and phase II dose expansion.
Eligibility criteria
Qualifiers
1. Patients must be willing and able to understand and sign the ICF, and to adhere to the study visit schedule and other protocol requirements.
2. Patients with histologically confirmed melanoma or other advanced solid tumor.
3. Patients who have undergone at least one systemic therapy and have radiologically or clinically determined progressive disease (PD) during or after most recent line of therapy, and for whom no further standard therapy is available, or who are intolerable to standard therapy.
4. Patients must have at least one measurable lesion as per RECIST version 1.1.
Disqualifiers
1. Prior treatment with any agent that has the same target.
2. Central nervous system (CNS) metastasis.
3. Active or chronic skin disorder requiring systemic therapy.
4. History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.
Trial design
Treatments tested in this trial
- AMT-253 for injection
Treatment groups
96 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov