LuMIERE: A Phase 1/2, Multicenter, Open label, Non randomized Study to Investigate Safety and Tolerability, Pharmacokinetics, Dosimetry, and Preliminary Activity of [177Lu]Lu FAP 2286 in Participants with an Advanced Solid Tumor

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508995-12-01

Acronym

CAAA614A12101

Enrollment

Registered

2025-08-26

Start date

2025-12-24

Completion date

Unknown

Last updated

2026-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC), Metastatic Breast Carcinoma (BC), Recurrent or metastatic non-small cell lung cancer (NSCLC)

Brief summary

Investigator-assessed ORR per RECIST v1.1, Dose-limiting toxicities (DLTs), adverse events (AEs), serious AEs (SAEs) and clinical laboratory abnormalities

Detailed description

DOR per RECIST v1.1, as assessed by investigator, Confirmed partial response (PR) or complete response (CR), or stable disease (SD) of at least 12 weeks, Disease progression according to RECIST v1.1, as assessed by investigator, or death due to any cause, AEs, SAEs, and clinical laboratory abnormalities at the RP2D of [177Lu]Lu-FAP-2286 for monotherapy, the RP2D in combination with mFOLFIRINOX in PDAC and the RP2D in combination with nab-paclitaxel in NSCLC (Phase 2 dose expansion), AEs and SAEs during and after [68Ga]Ga-FAP-2286 administration

Interventions

DRUGAbraxane

DRUGCAAA614A12101

DRUGPACLITAXEL ALBUMIN-BOUND

DRUGOXALIPLATIN

DRUGFLUOROURACIL

DRUGAAA614

DRUGIRINOTECAN

DRUGAAA514

DRUGCALCIUM FOLINATE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Investigator-assessed ORR per RECIST v1.1, Dose-limiting toxicities (DLTs), adverse events (AEs), serious AEs (SAEs) and clinical laboratory abnormalities	—

Secondary

Measure	Time frame
DOR per RECIST v1.1, as assessed by investigator, Confirmed partial response (PR) or complete response (CR), or stable disease (SD) of at least 12 weeks, Disease progression according to RECIST v1.1, as assessed by investigator, or death due to any cause, AEs, SAEs, and clinical laboratory abnormalities at the RP2D of [177Lu]Lu-FAP-2286 for monotherapy, the RP2D in combination with mFOLFIRINOX in PDAC and the RP2D in combination with nab-paclitaxel in NSCLC (Phase 2 dose expansion), AEs and SAEs during and after [68Ga]Ga-FAP-2286 administration	—

Measure

Time frame

—

Countries

Belgium, France, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026