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177LU-FAP-2286

Clinical trials are studying 177LU-FAP-2286 in people with advanced solid tumors. The trials look at safety, tolerability, how the body handles the treatment, and early signs of benefit. They include patients with recurrent or metastatic non-small cell lung cancer, pancreatic ductal adenocarcinoma, and metastatic breast cancer.

Table of Contents

Trial overview

The main study in the source data is LuMIERE, a Phase 1/2, multicenter, open-label, non-randomized trial of 177LU-FAP-2286 in people with advanced solid tumors.[1]

The study is authorized and includes 156 participants.[1]

Who is being studied

This trial includes people with recurrent or metastatic non-small cell lung cancer (NSCLC), locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC), and metastatic breast cancer.[1]

“Recurrent” means the cancer has come back after treatment, and “metastatic” means it has spread to other parts of the body.[1]

“Locally advanced unresectable” means the cancer has grown nearby and cannot be removed with surgery.[1]

Study design and phase

This is an interventional study, which means the researchers give a treatment and then watch what happens.[1]

It is open label, so the research team and participants know which treatment is being used.[1]

It is also non-randomized, which means treatment is not assigned by chance.[1]

The trial is designed as a Phase 1/2 study in the title, while the trial record lists Phase 2, showing that the study is focused on early dose finding and early testing of benefit.[1]

What the trial is measuring

The main effect measure is objective response rate (ORR) using RECIST v1.1, which is a standard way to check whether tumors shrink during treatment.[1]

Safety is also a major goal. The trial measures dose-limiting toxicities (DLTs), adverse events (AEs), serious adverse events (SAEs), and clinical laboratory abnormalities.[1]

These safety terms mean the study is watching for side effects, serious medical problems, and changes in blood tests or other lab results.[1]

The trial also aims to study pharmacokinetics, which is how the body handles the treatment, and dosimetry, which measures radiation dose patterns.[1]

Combination treatment plans

The brief summary says the study is evaluating 177LU-FAP-2286 with mFOLFIRINOX in pancreatic ductal adenocarcinoma and with nab-paclitaxel in non-small cell lung cancer.[1]

The researchers want to find the recommended Phase 2 dose (RP2D) for these combinations, which is the dose chosen after early testing as the best dose for later study.[1]

The summary also states that the Phase 2 dose expansion part is looking at objective response rate, while the dose escalation part is focused on safety, tolerability, and dose selection.[1]

Helpful patient terms

Multicenter means the trial is run at more than one hospital or study site.[1]

Dose escalation means the study may test different dose levels to find the safest useful dose.[1]

Dose expansion means more participants may be added after a dose is chosen, so researchers can learn more about how well it works.[1]

RECIST v1.1 is a standard research method used to measure tumor response on scans.[1]

Clinical laboratory abnormalities means unusual blood test or lab results that may show a treatment effect on the body.[1]

Trial ID Phase Condition studied Status Enrollment
NCT04939610 Phase 2 Advanced solid tumors, including recurrent or metastatic NSCLC, locally advanced unresectable or metastatic PDAC, and metastatic breast cancer Authorised 156

FAQ

  • What is being studied in trials of 177LU-FAP-2286? The trials are checking safety, tolerability, how the body processes the treatment, radiation dose patterns, and early anti-cancer activity. They also look at how well 177LU-FAP-2286 works when given with other cancer treatments.
  • Who may be able to join these trials? The trial includes people with advanced solid tumors, especially recurrent or metastatic non-small cell lung cancer, locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma, and metastatic breast cancer. Exact entry rules are set by the study team.
  • What phase is the trial of 177LU-FAP-2286? The study is a Phase 1/2 trial. Phase 1/2 studies usually first check safety and the right dose, then look for early signs that the treatment may help.
  • What outcomes are the researchers measuring? The main outcomes include objective response rate, which means how many tumors shrink, and dose-limiting toxicities, which are side effects that may stop dose increases. The study also tracks adverse events, serious adverse events, and lab changes.
  • Is this trial testing 177LU-FAP-2286 alone or with other treatments? The trial studies 177LU-FAP-2286 in combination with mFOLFIRINOX for pancreatic cancer and with nab-paclitaxel for non-small cell lung cancer. It is also looking for the recommended Phase 2 dose for these combinations.

Ongoing Clinical Trials on 177LU-FAP-2286

  • Study of 177Lu-FAP-2286 alone and with drug combinations for patients with advanced solid tumors including non-small cell lung cancer, breast cancer, and pancreatic cancer

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Italy Spain

Glossary

  • Advanced solid tumor: A cancer that has grown beyond its original site or cannot be removed easily with surgery.
  • Non-small cell lung cancer (NSCLC): The most common type of lung cancer. In this trial, the focus is on recurrent or metastatic disease.
  • Pancreatic ductal adenocarcinoma (PDAC): A common type of pancreatic cancer that starts in the ducts of the pancreas.
  • Metastatic breast cancer: Breast cancer that has spread to other parts of the body.
  • Phase 1/2: An early clinical trial phase that studies safety, dose, and early signs of benefit.
  • Open label: A study where both the researchers and participants know which treatment is being given.
  • Non-randomized: A study where treatment is not assigned by chance.
  • Pharmacokinetics: How the body absorbs, moves, and removes a treatment.
  • Dosimetry: A way to measure the radiation dose delivered to the body or tissues.
  • Objective response rate (ORR): The percentage of patients whose tumors shrink or disappear during treatment.
  • Dose-limiting toxicities (DLTs): Side effects that are serious enough to limit how much treatment can be given.
  • Recommended Phase 2 dose (RP2D): The dose chosen for later studies after early testing shows it is suitable.

References