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Solid TumorPhase 1/2LuMIERENCT04939610

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

A Phase 1/2 study testing 68Ga-FAP-2286 and 177Lu-FAP-2286 in people with Solid Tumor, run by Novartis Pharmaceuticals at 41 sites in 6 countries.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
68Ga-FAP-2286 and 177Lu-FAP-2286
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
222 participants
Where
41 sitesin 6 countries
Study dates
30 Jul 2021to 30 Jun 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Eligible participants must meet the following inclusion criteria. The criteria below apply to participants enrolling in Phase 1 and Phase 2, unless otherwise specified.
  • Have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved Informed Consent Form (ICF) prior to any study-specific evaluation.
  • Be ≥ 18 years of age at the time the ICF is signed.
  • Have consented to submission of fresh or archival tumor tissue, if available.
  • 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:
  • 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. Hepatic Function: i. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × institutional upper limit of normal (ULN); if liver metastases, then ≤ 5 × the institutional ULN; ii. Serum Bilirubin ≤ 1.5 × institutional ULN or if known Gilbert's syndrome then ≤ 3 × institutional ULN; iii. Serum albumin ≥ 30 g/L (3 g/dL) and iv. INR ≤ 1.5 x ULN and activated partial thromboplastin time (aPTT)≤1.5 x ULN. This applies to participants who are not receiving therapeutic anticoagulation, participants receiving therapeutic anticoagulation should be on a stable dose.
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  • Renal Function: i. Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min using the Cockcroft Gault formula.
  • Have an Eastern Oncology Group (ECOG) performance status of 0 or 1.
  • Have a life expectancy of ≥ 6 months.
  • Have measurable disease per RECIST v1.1 meeting the following criteria:
  • At least 1 lesion of ≥ 10 mm in the longest diameter for a non lymph node or ≥ 15 mm in the short axis diameter for a lymph node that is serially measurable according to RECIST v1.1 using conventional CT and/or MRI.
  • Lesions that have had external beam radiotherapy or loco-regional therapies such as radiofrequency ablation must show subsequent evidence of substantial size increase to be deemed a target lesion.
  • For Phase 1 only:
  • Have a histologically and/or cytologically confirmed advanced/metastatic solid tumor not amenable to treatment with curative intent:
  • Tumor must be refractory to or have progressed following prior treatment and have no satisfactory alternative treatment options.
  • For Phase 2 only:
  • Have cytologically or histologically and radiologically confirmed recurrent or metastatic disease as outlined below:
  • Pancreatic Cancer monotherapy group: i. Pancreatic ductal adenocarcinoma (ductal adenocarcinoma and related subtypes eligible; endocrine and neuroendocrine tumors excluded) ii. Participants must have progressed after at least 1, but no more than two prior chemotherapy regimens for locally advanced unresectable or metastatic disease.
  • Criteria b through h removed during Protocol amendment 7. i. Pancreatic Cancer combination group (with mFOLFIRINOX) i. Pancreatic ductal adenocarcinoma (ductal adenocarcinoma and related subtypes eligible; endocrine and neuroendocrine tumors excluded); ii. Participants have not received prior systemic therapy for metastatic disease.
  • Non-small cell lung cancer monotherapy group i. Non-small cell lung cancer (adenocarcinoma and squamous eligible; endocrine, neuroendocrine and small cell tumors are excluded) ii. Participants must have progressed after at least 1 but not more than 2 prior systemic regimens including chemotherapy and immunotherapy. Participants with NSCLC and targeted therapy treatment options, are eligible for the clinical trial as long as they meet these criteria (progression after 1 or 2 prior therapies). Note: Participants with NSCLC harboring mutations amenable to targeted therapy treatment, are eligible if received targeted therapy as single agent or in combination in 1st or 2nd line of treatment; participants not eligible to receive such therapies in 1st or 2nd line are also eligible to participate to the study.
  • Participants who have received adjuvant or neoadjuvant platinum-doublet chemotherapy (after surgery and/or radiation therapy) and an immune checkpoint inhibitor and developed recurrent or metastatic disease while on or within 12 months of completing therapy are eligible. Participants with NSCLC and targeted therapy treatment options are eligible for the clinical trial as long as they meet these criteria.
  • Participants with recurrent disease > 12 months after adjuvant or neoadjuvant platinum-based chemotherapy, who also subsequently progressed during or after a platinum-doublet regimen and an immune checkpoint inhibitor (given either together or sequentially to treat the recurrence), are eligible v. Participants must have received platinum-based chemotherapy for advanced or metastatic disease and immune checkpoint inhibitor either together (in the same line of treatment) or sequentially (two different lines of treatment) and then progressed.
  • Non small cell lung cancer combination group i. Non-small cell lung cancer (adenocarcinoma and squamous eligible; endocrine, neuroendocrine and small cell tumors are excluded) ii. Participants must have progressed after at least 1 but not more than 2 prior systemic regimens including chemotherapy and immunotherapy. Participants with NSCLC and targeted therapy treatment options, are eligible for the clinical trial as long as they meet these criteria (progression after 1 or 2 prior therapies). Note: Participants with NSCLC harboring mutations amenable to targeted therapy treatment, are eligible if received targeted therapy as single agent or in combination in 1st or 2nd line of treatment; participants not eligible to receive such therapies in 1st or 2nd line are also eligible to participate to the study.
  • Participants who have received adjuvant or neoadjuvant platinum-doublet chemotherapy (after surgery and/or radiation therapy) and an immune checkpoint inhibitor and developed recurrent or metastatic disease while on or within 12 months of completing therapy are eligible iv. Participants with recurrent disease > 12 months after adjuvant or neoadjuvant platinum-based chemotherapy, who also subsequently progressed during or after a platinum-doublet regimen and an immune checkpoint inhibitor (given either together or sequentially to treat the recurrence), are eligible v. Participants must not have received prior taxane therapy either as monotherapy or in combination.
  • Breast cancer monotherapy group i. HR positive HER2 negative
  • Participant has a histologically and/or cytologically documented diagnosis of HR positive HER2 negative metastatic breast cancer (based on the most recently analyzed tissue sample tested by a local laboratory).
  • Participants must have progressed on at least one line of hormone-based therapy (either alone or in combination) and at least one, but not more than two lines of chemotherapy (including cytotoxic, targeted and/or anti-drug conjugate therapies) for metastatic disease.
  • HER2 positive
  • Participant has a histologically and/or cytologically documented diagnosis of HER2 positive metastatic breast cancer (based on the most recently analyzed tissue sample tested by a local laboratory).
  • Participant must have progressed on at least two lines of HER2 targeted therapy for metastatic disease.
  • Triple negative breast cancer (TNBC)
  • Participant has a histologically and/or cytologically documented diagnosis of TNBC (based on the most recently analyzed tissue sample tested by a local laboratory).
  • Participants must have progressed on at least two lines of cytotoxic chemotherapy (including cytotoxic, anti-drug conjugate, targeted therapies and/or IO) for metastatic disease.

Who cannot join

  • Participants who meet any of the following criteria will be excluded from the study. The criteria below apply to participants enrolling in Phase 1 or Phase 2.
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  • Active malignancy except for the specific cancer under investigation in this study, ie, participant known to have potentially fatal cancer present for which he/she may be (but not necessarily) currently receiving treatment with the following exceptions:
  • History of second malignancy that has been successfully treated, with no evidence of active cancer for 3 years prior to enrollment;
  • Surgically cured low-risk tumors, such as early-stage cervical or endometrial cancer, any cancer in situ, or non-melanoma skin cancers; and
  • Prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen.
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  • Symptomatic and/or untreated CNS metastases or leptomeningeal disease or with primary tumor of CNS origin.
  • Participants with asymptomatic, previously treated CNS metastases are eligible provided they have been clinically stable for at least 4 weeks and have completed RT> 2 weeks prior to treatment. Participants may be on corticosteroids if on a stable dose equivalent to prednisone 10 mg daily or less.
  • Received anticancer treatment with chemotherapy, antibody therapy or other immunotherapy, gene therapy, vaccine therapy, angiogenesis inhibitors, or experimental drugs ≤ 14 days prior (≤ 28 days prior in case of checkpoint inhibitor therapy and other antibody therapies) to the administration of [177Lu]Lu FAP 2286.
  • Received prior radiopharmaceutical therapy (eg, radium 223 223Ra-dichloride, [177Lu]Lu-DOTA-TATE, [177Lu]Lu-prostate-specific membrane antigen (PSMA)-617, actinium 225 [225Ac]Ac PSMA-617, etc.) or prior EBRT to more than 25% of the bone marrow or received any prior EBRT directly to kidney, or received any EBRT within 2 weeks prior to administration of [177Lu]Lu FAP 2286.
  • Prior administration of a radiopharmaceutical unless 10 or more half-lives have elapsed before injection/infusion of [68Ga]Ga-FAP-2286 or [177Lu]Lu FAP 2286.
  • Ongoing adverse effects from anticancer treatment NCI-CTCAE v5.0 (or higher) Grade 1, with the exception for alopecia and vitiligo.
  • Exclusion criteria 6 and 7 are removed with Protocol Amendment 7. 8. Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
  • Clinically significant and/or uncontrolled cardiac disease such as congestive heart failure requiring treatment (New York Heart Association > Class 2), uncontrolled hypertension, clinically significant arrhythmia, or congenital prolonged QT syndrome;
  • Corrected QT interval (Fridericia's formula) > 450 msec for males or > 470 msec for females at Screening; or
  • Acute coronary syndrome or acute myocardial infarction ≤ 6 months prior to administration of [177Lu]Lu FAP 2286.
  • 9. Active severe urinary incontinence, severe voiding dysfunction, or urinary obstruction requiring an indwelling/condom catheter that, in the judgment of the investigator, could prevent adhering to radiation safety instructions.
  • 10. Severe chronic or active HIV infection:
  • Participants on effective antiretroviral therapy with undetectable viral load within 6 months prior to the first dose of [177Lu]Lu FAP 2286 are eligible.
  • Exclusion criteria 11 and 12 are removed with Protocol Amendment 7. 13. Non-study-related minor surgical procedure ≤ 5 days, or major surgical procedure ≤ 21 days, prior to the administration of [177Lu]Lu FAP 2286; in all cases, the participant must be sufficiently recovered and stable before treatment administration.
  • 14. The following are exclusion criteria, as applicable:
  • Female participants of childbearing potential: i. Refusal to use a highly effective method of contraception or to practice true abstinence during treatment and for 6 months following the last dose of investigational product; ii. Pregnant, suspected pregnancy, or breast feeding; iii. Planning on getting pregnant during treatment and for 6 months following the last dose of investigational product.
  • Male participants with female partners of childbearing potential: i. Refusal to use a highly effective method of contraception or to practice true abstinence during treatment and for 6 months following the last dose of investigational product.
  • All male participants: i. Refusal to use condoms during sex. ii. Planning to make semen donations during treatment and for 6 months following the last dose of investigational product.
  • 15. Significant weight loss (> 10% of body weight) within 28 days prior to providing informed consent for this study.
  • 16. Presence of any other condition that may increase the risk associated with study participation or interfere with the interpretation of study results, and, in the opinion of the investigator, would make the participant inappropriate for entry into the study.
  • 17. Inability to complete the needed investigational and standard imaging examinations due to any reason (e.g., severe claustrophobia, inability to lie still for the entire imaging time).
  • 18. Participants with known hypersensitivity to the active agent or excipients. 19. Severe chronic or active infections (including active tuberculosis, HBV, or HCV infection) requiring systemic antibacterial, antifungal or antiviral therapy within 2 weeks before enrollment.
  • Note: Antiviral therapy is permitted for participants with chronic HBV or HCV infection. Participants receiving antivirals at Screening should have been treated for > 2 weeks before enrollment. Inactive hepatitis B surface antigen (HbsAg) carriers treated and stable hepatitis B participants (HBV DNA < 500 IU/mL or < 2500 copies/mL) can be enrolled. Participants with detectable hepatitis B surface antigen (HbsAg) or detectable HBV DNA should be managed per treatment guidelines. Participants positive for HCV antibody are eligible only if PCR is negative for HCV RNA.

Trial locations and contacts

41 sites in 6 countries. Contact the study team or a site near you to ask about taking part.

Novartis Pharmaceuticals contact

1-888-689-6682

novartis.email@novartis.com

Novartis Pharmaceuticals contact

+41613241111

novartis.email@novartis.com

41 sites in 6 countries

United States20 sites, 20 recruiting

  • UAB Comprehensive Cancer Center

    Birmingham, Alabama, 35233

    Jonathan McConathy, jmcconathy@uabmc.edu

    Jonathan McConathy, MD

    Recruiting

  • UNC Hospitals

    Chapel Hill, North Carolina, 27514

    Recruiting

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

    Recruiting

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

    Recruiting

  • City of Hope

    Duarte, California, 91010

    Hannah Chang

    Recruiting

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

    Yusuf Menda, yusuf-menda@uiowa.edu

    Yusuf Menda

    Recruiting

  • Hoag Hospital Irvine

    Irvine, California, 92618

    Gary Ulaner, Gary.Ulaner@hoag.org

    Gary Ulaner

    Recruiting

  • Mayo Clinic

    Jacksonville, Florida, 32224

    Recruiting

  • University of California Los Angeles (UCLA)

    Los Angeles, California, 90095

    Nuclear Medine Department, 310-794-1005

    Dr. Zev Wainberg, MD

    Recruiting

  • University of Miami Hospital and Clinics

    Miami, Florida, 33136

    axc3268@med.miami.edu

    Dr. Aman Chauhan

    Recruiting

  • Columbia University Medical Center

    New York, New York, 10032

    Ryan Moy, rhm2147@cumc.columbia.edu

    Ryan Moy

    Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

    Recruiting

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Recruiting

  • Oregon Health and Science University

    Portland, Oregon, 97239-3098

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Recruiting

  • Univ of Utah, Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

    Recruiting

  • UCSF Medical Center

    San Francisco, California, 94158

    Andrew Ko, andrew.ko@ucsf.edu

    Andrew Ko

    Recruiting

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109-1023

    Recruiting

  • Saint Louis University Hospital

    St Louis, Missouri, 63110-2539

    Recruiting

Other trials in United States

France5 sites, 5 recruiting

  • Novartis Investigator Site

    Bordeaux, 33000

    Recruiting

  • Novartis Investigator Site

    Clermont-Ferrand, 63011

    Recruiting

  • Novartis Investigating Site

    Marseille, 13385

    Recruiting

  • Novartis Investigator Site

    Montpellier, Cedex 5, 34298

    Recruiting

  • Novartis Investigator Site

    Vandœuvre-lès-Nancy, 54511

    Recruiting

Other trials in France

Spain5 sites, 5 recruiting

  • Novartis Investigative Site

    A Coruña, 15006

    Manuel Fernandez Bruno

    Recruiting

  • Novartis Investigating Site

    Badalona, 08916

    Recruiting

  • Novartis Investigating Site

    Madrid, 28040

    Recruiting

  • Novartis Investigating Site

    Madrid, 28041

    Recruiting

  • Novartis Investigating Site

    Madrid, 28050

    Recruiting

Other trials in Spain

Australia4 sites, 4 recruiting

  • Novartis Investigative Site

    Adelaide, South Australia, 5000

    Recruiting

  • Novartis Investigative Site

    Melbourne, Victoria, 3000

    Dr. Hui-Li Wong, MD, huili.wong@petermac.org

    Dr. Brenda Lee, MD

    Recruiting

  • Novartis Investigative Site

    Melbourne, Victoria, 3004

    Recruiting

  • Novartis Investigator Site

    Murdoch, Western Australia, 6150

    Zeyad Al-Ogaili

    Recruiting

Other trials in Australia

Italy4 sites, 4 recruiting

  • Novartis Investigative Site

    Meldola, Emilia-Romagna, 47014

    Recruiting

  • Novartis Investigating Site

    Milan, 20141

    Recruiting

  • Novartis Investigator Site

    Naples, 80131

    Giuseppe Curigliano

    Recruiting

  • Novartis Investigating Site

    Reggio Emilia, 41123

    Recruiting

Other trials in Italy

Canada3 sites, 3 recruiting

  • Novartis Investigating Site

    London, Ontario, N6A 5W9

    Mina Swiha, mina.swiha@lhsc.on.ca

    Recruiting

  • Novartis Investigative Site

    Montreal, Quebec, H4A 3J1

    Recruiting

  • London Health Sciences Centre

    Toronto, Ontario, M4N 3M5

    Recruiting

Other trials in Canada

About this study

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

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. Given the restricted expression profile, FAP is a promising target for peptide-targeted radionuclide imaging and therapeutic agents.

Phase 1 of this study is designed to evaluate the safety and establish the recommended intravenous (IV) Phase 2 dose (RP2D) for [177Lu]Lu FAP 2286 monotherapy in participants with FAP expressing solid tumors.

Read more

Phase 2 is designed to evaluate the safety and efficacy of [177Lu]Lu FAP 2286 as monotherapy in participants with pancreatic ductal adenocarcinoma (PDAC), non-small cell lung cancer (NSCLC), and breast cancer (BC) and in combination with chemotherapy in participants with untreated PDAC or relapsed NSCLC.

Participants in both Phase 1 and 2 will be selected for treatment with [177Lu]Lu FAP 2286 based on [68Ga]Ga FAP 2286 imaging for determining tumor FAP expression.

Read the detailed description

Screening Period:

All participants will undergo screening assessments including disease assessments per CT or MRI per RECIST v1.1 criteria prior to administration of [68Ga]Ga FAP 2286. Each participant must provide informed consent and agree to provide an archival tumor tissue sample, if available, and blood samples for biomarker assessment. Participants must meet all entry criteria as specified in the protocol.

In Phase 1 only, participants will also undergo FDG-PET imaging. In the Phase 2 part, [177Lu]Lu FAP 2286 will be investigated in monotherapy and in combination with chemotherapy. All participants in the combination group may begin chemotherapy prior to [177Lu]Lu FAP 2286.

Participants meeting entry criteria will be enrolled and participants who have not had prior PET/CT imaging with [68Ga]Ga FAP 2286 in the previous 3 months (applicable only to Phase 1) will undergo PET imaging with [68Ga]Ga FAP prior to initiating treatment with [177Lu]Lu FAP 2286. Participants must have a positive [68Ga]Ga FAP PET/CT scan, as described in the criteria for continuation to [177Lu]Lu FAP 2286 therapy, in order to be treated with [177Lu]Lu FAP 2286.

Treatment Period:

A single IV dose of [177Lu]Lu FAP 2286 will be initially administered every 6 weeks (window of - 1 to + 7 days) up to a maximum of 6 doses in Phase 1. In Phase 2, [177Lu]Lu FAP 2286 will be administered every 4 weeks (28 days ± 3 days).

All participants will be monitored for safety throughout the Treatment Period. All participants will be assessed for disease status per RECIST v1.1 every 6 weeks (42 days). Participants will receive [177Lu]Lu FAP 2286 until the maximum doses allowed are administered, confirmed radiographic disease progression assessed by investigator based on RECIST v1.1 criteria, unequivocal clinical disease progression, unacceptable toxicity or inability to tolerate further treatment, loss to follow-up, or withdrawal of consent.

Safety data will be periodically reviewed by the DCRC during dose escalation and by a Data Monitoring Committee (DMC) during dose expansion.

End of Treatment (EOT) Visit:

In Phase 1, participants will have an EOT Visit 6 to 8 weeks after the last dose of [177Lu]Lu FAP 2286 except in cases of participant death, loss to follow up, or withdrawal of consent for further follow up. Participants in Phase 2 will have an EOT visit within 28 days from the last dose of study treatment except in case of participant death, loss to follow-up, or withdrawal of consent for further follow-up.

Post treatment safety follow-up:

In Phase 2, after discontinuation of study treatment for any reason, all participants will have safety follow-up for 6 weeks (+/- 1 week) after their last study treatment administration, except in case of death, loss to follow-up or withdrawal of consent as per the schedule of assessments.

Long-term Follow-up (LFTU) Period:

Upon completion of the EOT Visit, participants will enter the LTFU Period. The LTFU Period will include safety, disease, and survival assessments, as applicable.

  • Safety assessments will be performed every 12 weeks (+/- 1 week) for 2 years, then every 6 months until 5 years.
  • Disease assessments will be performed for all participants who complete the EOT for a reason other than radiographic disease progression. Participants should continue to have tumor scans performed until radiographic disease progression, death, loss to follow-up, withdrawal from study, study closure or initiation of subsequent anticancer treatment.
  • Survival assessments will be performed for all participants.
Conditions
Solid Tumor
Being tested
68Ga-FAP-2286, 177Lu-FAP-2286
Keywords
177Lu-FAP-2286, 68Ga-FAP-2286, Theranostic, FAP-2286, Fibroblast Activation Protein (FAP), Dosimetry, cancer-associated fibroblasts (CAF), Peptide-Targeted Radioligand Therapy (PTRT), Peptide Receptor Radionuclide Therapy (PRRT), Targeted radioligand therapy (TRT), Targeted radionuclide therapy, Lutetium-177, Gallium-68

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 68Ga-FAP-2286Drug

    68Ga-FAP-2286 IV administered as imaging agent for PET scan.

  • 177Lu-FAP-2286Drug

    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.

Study groups in NCT04939610
Study groupRoleWhat they receive
Phase 1: Dose EscalationExperimentalUp to 30 patients with solid tumors.
Receives: Drug: 68Ga-FAP-2286; Drug: 177Lu-FAP-2286
Phase 2: Specific Solid TumorsExperimentalUp to 192 participants treated with [177Lu]Lu-FAP-2286 in tumor-specific participant groups in monotherapy and in combination with chemotherapy.
Receives: Drug: 68Ga-FAP-2286; Drug: 177Lu-FAP-2286

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1: Dose-limiting toxicity (DLTs)

    To evaluate the safety and tolerability of [177Lu]Lu FAP 2286 and determine the RP2D

    Measured: From first dose of study drug through at least 6-8 weeks after end of treatment (up to approximately 2 years)

  2. Phase 1: recommended Phase 2 dose (RP2D)

    To evaluate the safety and tolerability of [177Lu]Lu FAP 2286 and determine the RP2D

    Measured: From first dose of study drug through at least 6-8 weeks after end of treatment (up to approximately 2 years)

  3. Phase 1: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of [177Lu]Lu FAP 2286

    To evaluate the safety and tolerability of [177Lu]Lu FAP 2286 and determine the RP2D

    Measured: From first dose of study drug through at least 6-8 weeks after end of treatment (up to approximately 2 years)

  4. Phase 2: Objective Response Rate (ORR)

    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.

    Measured: 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

  5. Phase 2: Dose-limiting toxicity (DLTs)

    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)

    Measured: Assessed within 4 weeks of first Lu-FAP2286 treatment

  6. Phase 2: recommended Phase 2 dose (RP2D)

    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)

    Measured: From first dose of study drug through at least 6-8 weeks after end of treatment (up to approximately 2 years)

  7. Phase 2: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of [177Lu]Lu FAP 2286

    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)

    Measured: From first dose of study drug through at least 6-8 weeks after end of treatment (up to approximately 2 years)

Secondary outcomes (17)

  1. Phase 1: Absorbed dose (Gy) estimated in organs and tumor lesions

    To measure the radiation dosimetry of [177Lu]Lu FAP 2286

    Measured: From first dose of study drug until disease progression or end of treatment (up to approximately 9 months)

  2. Phase 1: Maximum standardized uptake value (SUVmax) in tumor lesions

    To determine tumor uptake using [68Ga]Ga FAP 2286

    Measured: Taken within 2 hours after 68Ga-FAP-2286 IV administration

  3. Phase 1: Comparison of SUVmax in tumor lesions

    To evaluate tumor uptake of [68Ga]Ga FAP 2286 as compared to FDG

    Measured: From time of screening FDG PET/CT to 68Ga-FAP-2286 PET/CT (up to approximately 1 month)

  4. Phase 1: Concentration of [177Lu]Lu FAP 2286 at the end of infusion (Ceoi)

    To evaluate the PK of [177Lu]Lu FAP 2286

    Measured: 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)

  5. Phase 1: Cmax of [177Lu]Lu FAP 2286

    To evaluate the PK of [177Lu]Lu FAP 2286

    Measured: 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)

  6. Phase 1: Tmax of [177Lu]Lu FAP 2286

    To evaluate the PK of [177Lu]Lu FAP 2286

    Measured: 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)

  7. Phase 1: Area under the curve (AUC) of [177Lu]Lu FAP 2286

    To evaluate the PK of [177Lu]Lu FAP 2286

    Measured: 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)

  8. Phase 1: Clearance (CL) of [177Lu]Lu FAP 2286

    To evaluate the PK of [177Lu]Lu FAP 2286

    Measured: 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)

  9. Phase 1: Volume of distribution (Vd) of [177Lu]Lu FAP 2286

    To evaluate the PK of [177Lu]Lu FAP 2286

    Measured: 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)

  10. Phase 1: Half-life (T1/2) of [177Lu]Lu FAP 2286

    To evaluate the PK of [177Lu]Lu FAP 2286

    Measured: 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)

  11. Phase 1: Objective Response Rate (ORR)

    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.

    Measured: 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 57 months

  12. Phase 1: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of [68Ga]Ga FAP 2286

    To evaluate the safety and tolerability of [68Ga]Ga FAP 2286.

    Measured: Up to approximately 57 months

  13. Phase 2 (Dose expansion): Duration of Response (DoR)

    Duration of Response (DOR) was defined as the duration between the date of first documented Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) and the date of first documented radiographic progression or death due to any cause as assessed by investigator according to RECIST v1.1.

    Measured: From first documented evidence of CR or PR (the response prior to confirmation) until time of documented disease progression or death due to any cause, whichever comes first, assessed up to approximately 83 months

  14. Phase 2 (Dose expansion): Disease Control Rate (DCR)

    Disease Control Rate (DCR) is defined as the frequency and percentage of participants with stable disease (SD) of at least 12 weeks (2 consecutive scans with Best Overall Response (BOR) of SD) or a best confirmed response of CR or PR.

    Measured: 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 83 months

  15. Phase 2 (Dose expansion): Progression-free survival (PFS)

    Progression-free survival (PFS) is defined as the time from the date of randomization to the date of first evidence of radiographic progression or death due to any cause, whichever occurred first.

    Measured: From date of first [177Lu]Lu FAP 2286 treatment until date of progression or date of death from any cause, whichever come first, assessed up to 83 months

  16. Phase 2 (Dose expansion): Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of [177Lu]Lu FAP 2286 at the RP2D

    The distribution of adverse events of [177Lu]Lu FAP 2286 at the RP2D for monotherapy, the RP2D in combination with mFOLFIRNOX in PDAC and the RP2D in combination with nab-paclitaxel in NSCLC will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.

    Measured: Up to approximately 83 months

  17. Phase 2: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) of [68Ga]Ga FAP 2286

    The distribution of adverse events for [68Ga]Ga FAP 2286 will be done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs) and Deaths due to AEs, through the monitoring of relevant clinical and laboratory safety parameters.

    Measured: Up to approximately 83 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2021
  2. Study start30 Jul 2021
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
222 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04939610
Sponsor's protocol ID
CO-2286-114
Other IDs
CAAA614A12101, 2023-508995-12-00, 2023
Acronym
LuMIERE
Status last verified
Jul 2026
First submitted
9 Jun 2021
Last updated
24 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • McConathy J, Koshkin VS, Menda Y, Rodon J, Goenka AH, Moy RH, Morse S, Demange A, Blumenstein L, Babaoglan B, Aimone P, Hope TA. Targeting Fibroblast Activation Protein with [177Lu]Lu-FAP-2286 in Patients with Advanced Solid Tumors in the Phase I LuMIERE Trial. Clin Cancer Res. 2026 Jun 1:10.1158/1078-0432.CCR-25-4356. doi: 10.1158/1078-0432.CCR-25-4356. Online ahead of print.

    PubMed 42223513

  • Taunk NK, Escorcia FE, Lewis JS, Bodei L. Radiopharmaceuticals for Cancer Diagnosis and Therapy: New Targets, New Therapies-Alpha-Emitters, Novel Targets. Cancer J. 2024 May-Jun 01;30(3):218-223. doi: 10.1097/PPO.0000000000000720.

    PubMed 38753757

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 68Ga-FAP-2286 and 177Lu-FAP-2286 in people with Solid Tumor, run by Novartis Pharmaceuticals at 41 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United States, France, Spain, Australia, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novartis Pharmaceuticals (1-888-689-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04939610, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.

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