A Phase 1 Study of 177Lu-IM-3050 in Participants With Advanced Cancer
ConditionSolid Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorImmunome, Inc.
About this trial
IM-3050-101 is a Phase 1 study to determine the safety and effectiveness of 177Lu-IM-3050 in treating participants with advanced cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years of age
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0, 1 or 2
Histological or cytological diagnosis of a solid tumor
Participants must be refractory to or have relapsed after at least one prior standard therapeutic regimen. Participants must be relapsed or refractory to, have developed an intolerance to, or not be candidates for available therapies with established benefit.
Disqualifiers
Participant has received certain prior radiation therapy as detailed in the protocol
Participant has undergone major surgery within 4 weeks or minor surgery within 2 weeks of starting 177Lu-IM-3050 or has known active central nervous system (CNS) primary tumor or metastases and/or carcinomatous meningitis.
Participant has a known history of malignant primary brain tumor, or another primary solid or hematologic malignancy (other than that under study), unless the participant has undergone potentially curative therapy with no evidence of that disease for at least 2 years and approved by the Medical Monitor.
Recent or ongoing serious infection or other significant medical condition as detailed in the protocol.
Trial design
Design model
Sequential
Treatments tested in this trial
177Lu-IM-3050
Drug177Lu-IM-3050 is a FAP-directed radiopharmaceutical
Treatment groups
105 Participants
are divided into 2 treatment groupsGroup A: Dose Escalation: 177Lu-IM-3050Experimental treatment 1 intervention
Group B: Dose Expansion: 177Lu-IM-3050Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and tolerability of 177Lu-IM-3050 in participants with advanced solid tumors as measured by incidence of treatment emergent adverse events (TEAEs)
Type, frequency, seriousness, and severity of adverse events (AEs) graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 6.0, including adverse events (SAEs), AEs leading to discontinuation, and deaths
Time frame
From first dose of 177Lu-IM-3050 through at least 42 days following last dose of study treatment serious; up to approximately 5 years2
Determine the recommended dose of 177Lu-IM-3050 for further development
Type, frequency, seriousness, and severity of AEs graded using the NCI-CTCAE criteria version 6.0, including SAEs, AEs leading to discontinuation, and deaths
Time frame
From first dose of 177Lu-IM-3050 to 42 days following last dose of study treatment; up to approximately 5 yearsSecondary outcomes
1
Time course of blood radioactivity of 177Lu-IM-3050
Pharmacokinetic (PK) parameter: Area Under the Concentration Time Curve \[AUC\] in blood
Time frame
Through 42-49 days following last dose of 177Lu-IM-30502
Time course of blood radioactivity of 177Lu-IM-3050
Pharmacokinetic (PK) parameter: Maximum Concentration \[Cmax\] in blood
Time frame
Through 42-49 days following last dose of 177Lu-IM-30503
Time course of plasma IM-3050
PK parameter: Area Under the Concentration Time Curve \[AUC\] in blood
Time frame
Through 42-49 days following last dose of 177Lu-IM-30504
Time course of plasma IM-3050
PK parameter: Maximum Concentration \[Cmax\] in blood
Time frame
Through 42-49 days following last dose of 177Lu-IM-3050Sponsors and contacts
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Source ClinicalTrials.gov