NCT04939610 · Novartis Pharmaceuticals
A Study of 177Lu-FAP-2286 in Advanced Solid Tumors
(LuMIERE)
What this study is about
Fibroblast activation protein (FAP) is a cell surface protein that is highly expressed on the surface of cancer-associated fibroblasts (CAFs) present in the tumor microenvironment of most epithelial cancers, whereas limited expression of FAP is observed in normal tissues.
View original scientific description
Fibroblast activation protein (FAP) is a cell surface protein that is highly expressed on the surface of cancer-associated fibroblasts (CAFs) present in the tumor microenvironment of most epithelial cancers, whereas limited expression of FAP is observed in normal tissues. In some cancers of mesenchymal origin, notably sarcoma and mesothelioma, FAP expression has also been observed on the tumor cells themselves.
Interventions
DRUG
68Ga-FAP-2286
68Ga-FAP-2286 IV administered as imaging agent for PET scan.
DRUG
177Lu-FAP-2286
Phase 1: 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). Phase 2: Monotherapy: Patients with positive uptake of 68Ga FAP 2286 will receive a fixed dose of 177Lu FAP 2286 IV administered at the RP2D determined in Phase 1 dose escalation in every 4 weeks. Combination therapy: Patients with positive uptake of 68Ga FAP 2286 will receive 177Lu-FAP-2286 based on dose escalation (starting with dose level 1) followed by dose expansion at selected dose.
Primary outcome measures
Phase 1: Dose-limiting toxicity (DLTs)
Time frame: From first dose of study drug through at least 6-8 weeks after end of treatment (up to approximately 2 years)
To evaluate the safety and tolerability of \[177Lu\]Lu FAP 2286 and determine the RP2D
Phase 1: recommended Phase 2 dose (RP2D)
Time frame: From first dose of study drug through at least 6-8 weeks after end of treatment (up to approximately 2 years)
To evaluate the safety and tolerability of \[177Lu\]Lu FAP 2286 and determine the RP2D
Phase 1: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of [177Lu]Lu FAP 2286
Time frame: From first dose of study drug through at least 6-8 weeks after end of treatment (up to approximately 2 years)
To evaluate the safety and tolerability of \[177Lu\]Lu FAP 2286 and determine the RP2D
Phase 2: Objective Response Rate (ORR)
Time frame: From date of first [177Lu]Lu FAP 2286 treatment until date of radiographic progression or date of death from any cause, whichever comes first, assessed up to 59 months
Objective response is defined as a best confirmed response of CR or PR by RECIST v1.1 as assessed by the investigator. A confirmed CR or PR is a response that is maintained and documented on a subsequent tumor assessment no less than 28 days after the initial response. For Phase 2, ORR defined as the frequency and percentage of participants with a best confirmed response of CR or PR will be analyzed.
Phase 2: Dose-limiting toxicity (DLTs)
Time frame: Assessed within 4 weeks of first Lu-FAP2286 treatment
To evaluate the safety and tolerability of \[177Lu\]Lu FAP 2286 and determine the RP2D in combination with mFOLFIRINOX in PDAC and the RP2D in combination with nab-paclitaxel in NSCLC (Phase 2 dose escalation for combination therapy)
Phase 2: recommended Phase 2 dose (RP2D)
Time frame: From first dose of study drug through at least 6-8 weeks after end of treatment (up to approximately 2 years)
To evaluate the safety and tolerability of \[177Lu\]Lu FAP 2286 and determine the RP2D in combination with mFOLFIRINOX in PDAC and the RP2D in combination with nab-paclitaxel in NSCLC (Phase 2 dose escalation for combination therapy)
Phase 2: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of [177Lu]Lu FAP 2286
Time frame: From first dose of study drug through at least 6-8 weeks after end of treatment (up to approximately 2 years)
To evaluate the safety and tolerability of \[177Lu\]Lu FAP 2286 and determine the RP2D in combination with mFOLFIRINOX in PDAC and the RP2D in combination with nab-paclitaxel in NSCLC (Phase 2 dose escalation for combination therapy)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Eligible participants must meet the following inclusion criteria. The criteria below apply to participants enrolling in Phase 1 and Phase 2, unless otherwise specified. 1. Have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved Informed Consent Form (ICF) prior to any study-specific evaluation. 2. Be ≥ 18 years of age at the time the ICF is signed. 3. Have consented to submission of fresh or archival tumor tissue, if available. 4. Have adequate organ function confirmed by the following laboratory values obtained within the Screening Period prior to administration of \[68Ga\]Ga FAP 2286 and prior to first cycle of chemotherapy in the combination groups: a. Bone Marrow Function (independent of transfusion or growth factor support within 21 days prior to planned first administration of \[177Lu\]Lu FAP 2286): i. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; ii. Platelets \> 100 × 109/L; and iii.Hemoglobin ≥ 9 g/dL. b.
Where
- Birmingham, Alabama
- Duarte, California
- Irvine, California
- Los Angeles, California
- San Francisco, California
- Jacksonville, Florida
- Miami, Florida
- Chicago, Illinois
- Iowa City, Iowa
- Detroit, Michigan
- Rochester, Minnesota
- St Louis, Missouri
And 7 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 23, 2026 · Source of record for eligibility and locations