A Phase 1-1b Study to Evaluate the Safety, Efficacy and Dosimetry of Study Drug A9-3408 in Subjects With Metastatic Melanoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlpha-9 Oncology USA Inc.
About this trial
The goal of this trial is to see if this investigational drug is safe for adult patients with melanoma that has spread to other parts of the body or cannot be removed by surgery. It will also see if this investigational drug can shrink melanoma tumors in the body. The main questions this study aims to answer are:
* What are the side effects of this investigational drug? * What is the highest dose of this investigational drug that can be given safely?
Participants will:
* Take the investigational drug once every 6 weeks, for up to 6 times in total * Visit a doctor's office on a regular basis for checkups and tests
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able to provide written informed consent
[68Ga]Ga-A9T-3202 uptake in at least one measurable lesion (per RECIST v1.1) on PET scan
Histologically or cytologically confirmed unresectable or metastatic melanoma with disease progression on prior standard of care therapy
Adequate ECOG performance status
Disqualifiers
Previous treatment with radioactive nuclides except radioactive imaging tracers
Treatment with another investigational product shortly prior to first dose of [225Ac]Ac-A9-3408 with exception of anti-PD-1/PD-L1 agents.
Concurrent anticancer therapy
Major surgery within 4 weeks of first dose of investigational product
Trial design
Design model
Sequential
Treatments tested in this trial
[225Ac]Ac-A9-3408
DrugAdministered IV
[68Ga]Ga-A9T-3202
Diagnostic testAdministered IV
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Phase 1 Dose EscalationExperimental treatment 2 interventions
Group B: Phase 1B Dose ExpansionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Determine max tolerated dose and recommended Phase 2 Dose
Rate of DLTs per dose level/cohort
Time frame
First 28 days following first study treatment2
Incidence of treatment-related adverse events
Rate and severity of suspected treatment-related adverse events, change from baseline laboratory values and change from baseline vital signs as graded by CTCAE version 5.0
Time frame
From first study treatment until end of treatmentSecondary outcomes
1
Evaluate the preliminary efficacy of [225Ac]Ac-A9-3408 by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Percent of patients who achieve an overall response (ORR), defined as the percent of patients who achieve a complete response (CR) or partial response (PR) by RECIST v1.1
Time frame
Up to 1 year from enrollment2
Evaluate biodistribution and normal organ dosimetry of [225Ac]Ac-A9-3408
Absorbed radiation dose estimates (Gy) in normal organs for \[225Ac\]Ac-A9-3408
Time frame
Up to 7 days following each cycle (42 days)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov