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

This study is testing a new treatment called 177Lu-FAP-2286 for people with advanced solid tumors. This treatment targets a protein called FAP, which is often found on cancer cells. Before receiving 177Lu-FAP-2286, you would first have an imaging scan using 68Ga-FAP-2286 to see if your tumor has enough FAP. If it does, you would receive 177Lu-FAP-2286 intravenously (through a vein) every 6 weeks for up to 6 doses. The main goals of this study are to find a safe dose and understand any side effects of 177Lu-FAP-2286. This study is open to adults aged 18 and older.

Study design
This is an interventional study with a planned enrollment of 222 participants. It has two phases, with the first phase focused on finding a safe dose.
What's involved
You would undergo screening assessments, including scans, and provide tissue and blood samples. If eligible, you would receive 177Lu-FAP-2286 intravenously every 6 weeks for up to 6 doses.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for at least 6-8 weeks after your last treatment dose, for up to approximately 2 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04939610

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Novartis Pharmaceuticals
~222 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:68Ga-FAP-2286177Lu-FAP-2286

At a glance

Recruiting sites
41 of 41 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1: Dose-limiting toxicity (DLTs)
Measured over From first dose of study drug through at least 6-8 weeks after end of treatment (up to approximately 2 years)
+6 more outcomes measured

Conditions

Solid Tumor

Explore related trials

Breast CarcinomaLung Non-Small Cell CarcinomaPancreatic CarcinomaSolid NeoplasmProlyl Endopeptidase FAP

Where it's being run

41 sites across 25 states
Spain5
California4
France4
Italy3
Florida2
New York2
Victoria2
Ontario2

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-689-6682
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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.

Exclusion

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. 5. Ongoing adverse effects from anticancer treatment NCI-CTCAE v5.0 (or higher) Grade 1, with the exception for alopecia and vitiligo.

What this trial measures

  • Phase 1: Dose-limiting toxicity (DLTs)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)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 2286From 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)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)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)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 2286From 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)