Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 5 for:    lumiere

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04939610
Recruitment Status : Recruiting
First Posted : June 25, 2021
Last Update Posted : June 25, 2021
Sponsor:
Information provided by (Responsible Party):
Clovis Oncology, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: 68Ga-FAP-2286 Drug: 177Lu-FAP-2286 Phase 1 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : June 14, 2021
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : June 1, 2026

Arm Intervention/treatment
Experimental: Phase 1: Dose Escalation
Up to 30 patients with solid tumors.
Drug: 68Ga-FAP-2286
68Ga-FAP-2286 IV administered as imaging agent for PET scan.

Drug: 177Lu-FAP-2286
Patients with positive uptake of 68Ga-FAP-2286 will receive a fixed dose of 177Lu-FAP-2286 IV administered every 6 weeks for a maximum of 6 doses. Doses range between 3.7 and 9.25 GBq (100-250 mCi).

Experimental: Phase 1: RP2D Expansion Cohort
Up to 20 patients with solid tumors.
Drug: 68Ga-FAP-2286
68Ga-FAP-2286 IV administered as imaging agent for PET scan.

Drug: 177Lu-FAP-2286
Patients with positive uptake of 68Ga FAP 2286 will receive a fixed dose of 177Lu FAP 2286 IV administered at the RP2D and schedule determined in Phase 1 dose escalation.

Experimental: Phase 2: Specific Solid Tumors
Cohorts of up to 40 patients each with Advanced or Solid Tumors
Drug: 68Ga-FAP-2286
68Ga-FAP-2286 IV administered as imaging agent for PET scan.

Drug: 177Lu-FAP-2286
Patients with positive uptake of 68Ga FAP 2286 will receive a fixed dose of 177Lu FAP 2286 IV administered at the RP2D and schedule determined in Phase 1 dose escalation.




Primary Outcome Measures :
  1. 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) ]
    Incidence of adverse events, serious adverse events, and clinical laboratory abnormalities defined as dose-limiting toxicities (DLTs)

  2. Objective response rate (ORR) (Phase 2) [ Time Frame: From first dose of study drug until disease progression (up to approximately 2 years) ]
    Investigator-assessed Confirmed Response (CR) or Partial Response (PR) per RECIST v1.1


Secondary Outcome Measures :
  1. 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) ]
    Absorbed dose (gray [Gy]) estimated in organs and tumor lesions

  2. Tumor uptake using 68Ga-FAP-2286 (Phase 1) [ Time Frame: Taken within 2 hours after 68Ga-FAP-2286 IV administration ]
    Maximum standardized uptake value (SUVmax) in tumor lesions assessed by PET/CT scan

  3. 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) ]
    Comparison of SUVmax in tumor lesions

  4. 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) ]
    Concentration at the end of infusion (Ceoi)

  5. 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) ]
    Area under the curve (AUC)

  6. 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) ]
    Clearance (CL)

  7. 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) ]
    Volume of distribution (Vd)

  8. 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) ]
    Half-half-life (t1/2)

  9. 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) ]
    Investigator-assessed objective response by Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1

  10. Duration of response (DOR) (Phase 2) [ Time Frame: From time of initial response until disease progression (up to approximately 2 years) ]
    DOR per RECIST v1.1, as assessed by investigator

  11. Progression-free survival (PFS) (Phase 2) [ Time Frame: From first dose of study drug until disease progression (up to approximately 2 years) ]
    Disease progression according to RECIST v1.1, as assessed by investigator, or death due to any cause

  12. Overall survival (OS) (Phase 2) [ Time Frame: From first dose of study drug until death (up to approximately 3 years) ]
    Survival assessments conducted via visit or telephone call

  13. 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) ]
    Incidence of adverse events, serious adverse events, and clinical laboratory abnormalities

  14. 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) ]
    Incidence of Analysis of adverse events (AEs) and serious adverse events (SAEs)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04939610


Contacts
Layout table for location contacts
Contact: Clovis Oncology 1-415-409-7220, 1-844-258-7662 medinfo@clovisoncology.com

Locations
Layout table for location information
United States, Alabama
UAB Comprehensive Cancer Center Recruiting
Birmingham, Alabama, United States, 35233
United States, California
UCSF Medical Center Not yet recruiting
San Francisco, California, United States, 94158
United States, Iowa
University of Iowa Hospitals and Clinics Not yet recruiting
Iowa City, Iowa, United States, 52242
United States, New York
Columbia University Medical Center Not yet recruiting
New York, New York, United States, 10032
United States, Texas
University of Texas MD Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Clovis Oncology, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Thomas Hope, MD University of California, San Francisco
Layout table for additonal information
Responsible Party: Clovis Oncology, Inc.
ClinicalTrials.gov Identifier: NCT04939610    
Other Study ID Numbers: CO-2286-114
First Posted: June 25, 2021    Key Record Dates
Last Update Posted: June 25, 2021
Last Verified: June 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clovis Oncology, Inc.:
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms