A Phase 1 Study of 177Lu-IM-3050 in Participants With Advanced Cancer

Official title

A Phase 1 Study of 177Lu-IM-3050 in Participants With Advanced Malignancies

Overview

IM-3050-101 is a Phase 1 study to determine the safety and effectiveness of 177Lu-IM-3050 in treating participants with advanced cancer.

Detailed description

IM-3050-101 is a 2-part Phase 1 first-in-human (FIH), open-label, multicenter dose escalation and expansion study designed to determine the safety, tolerability, dosimetry, pharmacokinetics (PK), and preliminary anti-tumor activity of the radiopharmaceutical 177Lu-IM-3050 in participants with FAP-expressing advanced solid tumors. Part A of the study is a dose escalation phase to evaluate the safety, tolerability, preliminary anti-tumor activity, radiation dosimetry, and PK from escalating repeated doses of 177Lu-IM-3050 to determine maximum tolerated dose (MTD) and/or recommended expansion dose of 177Lu-IM-3050. Part B of the study is an expansion phase to further evaluate safety and tolerability of 177Lu-IM-3050 at the candidate recommended dose.

Interventions

• Drug 177Lu-IM-3050
  177Lu-IM-3050 is a FAP-directed radiopharmaceutical

Primary outcome measures

• Safety and tolerability of 177Lu-IM-3050 in participants with advanced solid tumors as measured by incidence of treatment emergent adverse events (TEAEs) [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 years]
• Determine the recommended dose of 177Lu-IM-3050 for further development [Time frame: From first dose of 177Lu-IM-3050 to 42 days following last dose of study treatment; up to approximately 5 years]

Secondary outcome measures (10)

• Time course of blood radioactivity of 177Lu-IM-3050 [Time frame: Through 42-49 days following last dose of 177Lu-IM-3050]
• Time course of blood radioactivity of 177Lu-IM-3050 [Time frame: Through 42-49 days following last dose of 177Lu-IM-3050]
• Time course of plasma IM-3050 [Time frame: Through 42-49 days following last dose of 177Lu-IM-3050]
• Time course of plasma IM-3050 [Time frame: Through 42-49 days following last dose of 177Lu-IM-3050]
• Evaluate the preliminary anti-tumor activity of 177Lu-IM-3050 in participants with advanced solid tumors [Time frame: Week 6 until disease progression or participant discontinuation from study]
• Evaluate the preliminary anti-tumor activity of 177Lu-IM-3050 in participants with advanced solid tumors [Time frame: Week 6 until disease progression or participant discontinuation from study]
• Evaluate the preliminary anti-tumor activity of 177Lu-IM-3050 in participants with advanced solid tumors [Time frame: Week 6 until disease progression or participant discontinuation from study]
• Evaluate the dosimetry of 177Lu-IM-3050 in participants with advanced solid tumors [Time frame: From first dose of 177Lu-IM-3050 3050 in Cycle 1 up to 8 days after Cycle 3 (each cycle is 42 days) or until participant discontinuation, whichever is earlier]
• Evaluate the dosimetry of 177Lu-IM-3050 in participants with advanced solid tumors [Time frame: From first dose of 177Lu-IM-3050 3050 in Cycle 1 up to 8 days after Cycle 3 (each cycle is 42 days) or until participant discontinuation, whichever is earlier]
• Safety and tolerability of FAP PET/CT imaging tracer in participants with advanced solid tumors as measured by incidence of TEAEs [Time frame: From dose of FAP PET/CT imaging tracer until end of study]

Eligibility criteria

Inclusion criteria

• ≥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.
• Participants must have measurable disease as per RECIST v.1.1 based on imaging performed during Screening.

• During Part A only, participants without measurable disease per RECIST v1.1 are eligible if approved by Medical Monitor.
• During screening, participants must have positive FAP PET/CT uptake as described in criteria for continuation of IM-3050 treatment.
• Participants must have adequate organ function.

Exclusion criteria

• 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.

Exception: The time requirement does not apply to participants who underwent successful definitive resection of certain cancers.

• Recent or ongoing serious infection or other significant medical condition as detailed in the protocol.
• Participant has received an investigational product or been treated with an investigational device within 30 days, or 5 half-lives prior to receiving the FAP PET/CT imaging tracer or 177Lu-IM-3050.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 3 centers

• Stanford University School of Medicine — Palo Alto
• University of Texas - MD Anderson Cancer Center — Houston
• Excel Diagnostics and Nuclear Oncology Center — Houston

Identifiers

NCT: NCT07505771 · IM-3050-101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗