Clinical Trials /

A Study of 177Lu-FAP-2286 in Advanced Solid Tumors (LuMIERE)

NCT04939610

Description:

Phase 1 of this study will evaluate the safety and tolerability of 177Lu-FAP-2286 and determine the recommended Phase 2 dose (RP2D) in patients with advanced solid tumors. Phase 2 of this study is designed to evaluate objective response rate (ORR) in patients with specific solid tumors.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of 177Lu-FAP-2286 in Advanced Solid Tumors (LuMIERE)
  • Official Title: LuMIERE: A Phase 1/2, Multicenter, Open-label, Non-randomized Study to Investigate Safety and Tolerability, Pharmacokinetics, Dosimetry, and Preliminary Activity of 177Lu-FAP-2286 in Patients With an Advanced Solid Tumor

Clinical Trial IDs

  • ORG STUDY ID: CO-2286-114
  • NCT ID: NCT04939610

Conditions

  • Solid Tumor

Interventions

DrugSynonymsArms
68Ga-FAP-2286Phase 1: Dose Escalation
177Lu-FAP-2286Phase 1: Dose Escalation
177Lu-FAP-2286Phase 1: RP2D Expansion Cohort

Purpose

Phase 1 of this study will evaluate the safety and tolerability of 177Lu-FAP-2286 and determine the recommended Phase 2 dose (RP2D) in patients with advanced solid tumors. Phase 2 of this study is designed to evaluate objective response rate (ORR) in patients with specific solid tumors.

Trial Arms

NameTypeDescriptionInterventions
Phase 1: Dose EscalationExperimentalUp to 30 patients with solid tumors.
  • 68Ga-FAP-2286
  • 177Lu-FAP-2286
Phase 1: RP2D Expansion CohortExperimentalUp to 20 patients with solid tumors.
  • 68Ga-FAP-2286
  • 177Lu-FAP-2286
Phase 2: Specific Solid TumorsExperimentalCohorts of up to 40 patients each with Advanced or Solid Tumors
  • 68Ga-FAP-2286
  • 177Lu-FAP-2286

Eligibility Criteria

        Inclusion Criteria:

          -  Be ≥ 18 years of age at the time the ICF is signed.

          -  Consent to submission of archival tumor tissue, if available.

          -  Adequate bone marrow, hepatic, and renal function.

          -  ECOG performance status of 0 or 1.

          -  Life expectancy of at least 6 months.

          -  Measurable disease per RECIST v1.1.

        Phase 1 only:

        • Patients must have an advanced/metastatic solid tumor that is refractory to or has
        progressed following prior treatment and has no satisfactory alternative treatment options.

        Patient enrolled in Phase 2 will have one of several specific tumor types with advanced or
        recurrent or metastatic disease following prior therapy.

        Exclusion Criteria:

          -  Active second malignancy that may interfere with the safety or efficacy assessments of
             this study

          -  Symptomatic and/or untreated central nervous system (CNS) metastases or leptomeningeal
             disease or with primary tumor of CNS origin. Patients must be clinically stable for at
             least 4 weeks without steroid treatment

          -  Received anticancer treatment ≤ 14 days prior to receiving study treatment (≤ 28 days
             prior in case of checkpoint inhibitor or other antibody therapies)

          -  Received prior radiopharmaceutical therapy or radioembolization, or prior extensive
             external beam radiation therapy (EBRT) to bone marrow or any prior EBRT to kidney, or
             received any EBRT within 2 weeks prior to administration of study treatment

          -  Ongoing adverse effects from anticancer treatment > Grade 1, with the exception of
             alopecia

          -  Known incompatibility with contrast media for CT or PET scans. Infection requiring
             systemic antibiotics within 2 weeks prior to administration of study treatment

          -  Impaired cardiac function or clinically significant cardiac disease

          -  Severe urinary incontinence, voiding dysfunction, or urinary obstruction

          -  Minor surgery ≤ 5 days, or major surgery ≤ 21 days, prior to administration of study
             treatment.

          -  Any other condition that may increase the risk associated with study participation or
             interfere with its interpretation.

          -  Refusal to use highly effective method of contraception, as applicable

          -  Pregnant or breastfeeding

          -  Any other condition that may increase the risk associated with study participation or
             interfere with its interpretation.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Determine the recommended Phase 2 dose of 177Lu-FAP-2286 (Phase 1)
Time Frame:From first dose of study drug through at least 6-8 weeks after end of treatment (up to approximately 2 years)
Safety Issue:
Description:Incidence of adverse events, serious adverse events, and clinical laboratory abnormalities defined as dose-limiting toxicities (DLTs)

Secondary Outcome Measures

Measure:Radiation dosimetry of 177Lu-FAP-2286 (Phase 1)
Time Frame:From first dose of study drug until disease progression or end of treatment (up to approximately 9 months)
Safety Issue:
Description:Absorbed dose (gray [Gy]) estimated in organs and tumor lesions
Measure:Tumor uptake using 68Ga-FAP-2286 (Phase 1)
Time Frame:Taken within 2 hours after 68Ga-FAP-2286 IV administration
Safety Issue:
Description:Maximum standardized uptake value (SUVmax) in tumor lesions assessed by PET/CT scan
Measure:Tumor uptake of 68Ga-FAP-2286 as compared to 2-deoxy-2-[18F]fluoro-D-glucose (FDG) (Phase 1)
Time Frame:From time of screening FDG PET/CT to 68Ga-FAP-2286 PET/CT (up to approximately 1 month)
Safety Issue:
Description:Comparison of SUVmax in tumor lesions
Measure:Pharmacokinetics (PK) of 177Lu-FAP-2286 (Phase 1)
Time Frame:From first dose of study drug to end of Cycle 6 with (each cycle ~ 6 weeks) (Total Time Frame estimated up to approximately 9 months)
Safety Issue:
Description:Concentration at the end of infusion (Ceoi)
Measure:Pharmacokinetics (PK) of 177Lu-FAP-2286 (Phase 1)
Time Frame:From first dose of study drug to end of Cycle 6 with (each cycle ~ 6 weeks) (Total Time Frame estimated up to approximately 9 months)
Safety Issue:
Description:Area under the curve (AUC)
Measure:Pharmacokinetics (PK) of 177Lu-FAP-2286 (Phase 1)
Time Frame:From first dose of study drug to end of Cycle 6 with (each cycle ~ 6 weeks) (Total Time Frame estimated up to approximately 9 months)
Safety Issue:
Description:Clearance (CL)
Measure:Pharmacokinetics (PK) of 177Lu-FAP-2286 (Phase 1)
Time Frame:From first dose of study drug to end of Cycle 6 with (each cycle ~ 6 weeks) (Total Time Frame estimated up to approximately 9 months)
Safety Issue:
Description:Volume of distribution (Vd)
Measure:Pharmacokinetics (PK) of 177Lu-FAP-2286 (Phase 1)
Time Frame:From first dose of study drug to end of Cycle 6 with (each cycle ~ 6 weeks) (Total Time Frame estimated up to approximately 9 months)
Safety Issue:
Description:Half-half-life (t1/2)
Measure:Preliminary efficacy of 177Lu-FAP-2286 in advanced solid tumors (Phase 1)
Time Frame:From first dose of study drug until disease progression (up to approximately 2 years)
Safety Issue:
Description:Investigator-assessed objective response by Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
Measure:Duration of response (DOR) (Phase 2)
Time Frame:From time of initial response until disease progression (up to approximately 2 years)
Safety Issue:
Description:DOR per RECIST v1.1, as assessed by investigator
Measure:Progression-free survival (PFS) (Phase 2)
Time Frame:From first dose of study drug until disease progression (up to approximately 2 years)
Safety Issue:
Description:Disease progression according to RECIST v1.1, as assessed by investigator, or death due to any cause
Measure:Overall survival (OS) (Phase 2)
Time Frame:From first dose of study drug until death (up to approximately 3 years)
Safety Issue:
Description:Survival assessments conducted via visit or telephone call
Measure:Further evaluate AEs, SAEs, and clinical laboratory abnormalities of 177Lu-FAP-2286 (Phase 2)
Time Frame:From first dose of study drug through at least 6-8 weeks after end of treatment (Total Time Frame estimated up to approximately 6 years)
Safety Issue:
Description:Incidence of adverse events, serious adverse events, and clinical laboratory abnormalities
Measure:Evaluate AEs and SAEs following administration of Safety of 68Ga-FAP-2286
Time Frame:From first dose of study drug through at least 6-8 weeks after end of treatment (up to approximately 1 year)
Safety Issue:
Description:Incidence of Analysis of adverse events (AEs) and serious adverse events (SAEs)

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Clovis Oncology, Inc.

Trial Keywords

  • 177Lu-FAP-2286
  • 68Ga-FAP-2286
  • theranostic
  • FAP-2286
  • FAP
  • fibroblast activation protein
  • dosimetry
  • CAF
  • cancer-associated fibroblasts
  • Peptide-Targeted Radioligand Therapy
  • PTRT
  • Peptide Receptor RadionuclideTherapy
  • PRRT
  • TRT
  • Targeted radioligand therapy
  • Target radionuclide therapy
  • Lutetium-177
  • Gallium-68

Last Updated

June 25, 2021