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.
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
Interventions
Drug | Synonyms | Arms |
---|
68Ga-FAP-2286 | | Phase 1: Dose Escalation |
177Lu-FAP-2286 | | Phase 1: Dose Escalation |
177Lu-FAP-2286 | | Phase 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
Name | Type | Description | Interventions |
---|
Phase 1: Dose Escalation | Experimental | Up to 30 patients with solid tumors. | - 68Ga-FAP-2286
- 177Lu-FAP-2286
|
Phase 1: RP2D Expansion Cohort | Experimental | Up to 20 patients with solid tumors. | - 68Ga-FAP-2286
- 177Lu-FAP-2286
|
Phase 2: Specific Solid Tumors | Experimental | Cohorts 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