AMT-676 in Patients With Advanced Solid Tumors
ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMultitude Therapeutics Inc.
About this trial
This is a first-in-human, open-label, multicenter Phase Ia/Ib study of AMT- 676, followed by an open-label, multicenter, dose-escalation.
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 pathologically confirmed unresectable advanced solid tumor. Preferred tumor types include colorectal cancer, gastric cancer, esophageal adenocarcinoma, cholangiocarcinoma, pancreatic ductal cancers, and neuroendocrine tumors.
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 treatment with any agent for the same target or ADC based on topoisomerase I inhibitor.
Central nervous system (CNS) metastasis
History of Steven's Johnson's syndrome or toxic epidermal necrolysis syndrome.
Persistent toxicities from previous systemic anti-neoplastic treatments of Grade >1.
Trial design
Design model
Single group
Treatments tested in this trial
AMT-676
DrugParticipants will receive AMT-676 administered intravenously. Participants will be observed for first instance of dose limiting toxicities (DLT).
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: AMT-676 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
30 days after the last dose of IMP2
Maximum Tolerated Dose (MTD)
The MTD will be determined using DLTs
Time frame
30 days after the last dose of IMP3
Type, incidence and severity of Adverse Events
Safety and tolerability profile assessed by the Common Terminology Criteria for Adverse Events v5.0
Time frame
30 days after the last dose of IMPSecondary outcomes
1
Maximum observed concentration (C[max])
Pharmacokinetic profile characterized by the maximum observed concentration (C\[max\]) of AMT-676
Time frame
30 days after the last dose of IMP2
Time to maximum concentration (Tmax)
Pharmacokinetic profile characterized by the time to maximum concentration (Tmax) of AMT-676
Time frame
30 days after the last dose of IMP3
Area under the curve (AUC)
Pharmacokinetic profile characterized by the area under the curve (AUC) of AMT-676
Time frame
30 days after the last dose of IMP4
Terminal half-life (t[1/2])
Pharmacokinetic profile characterized by the terminal half-life (t\[1/2\]) of AMT-676
Time frame
30 days after the last dose of IMPSponsors and contacts
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Source ClinicalTrials.gov