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NCT04939610 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Solid Tumor, sponsored by Novartis Pharmaceuticals.

Recruiting
Registry status
Phase 1
Development phase
222
Enrollment target
20
Study locations

NCT04939610: Recruiting Phase 1 study of Solid Tumor, sponsored by Novartis Pharmaceuticals.

NCT04939610 is a Phase 1 study of Solid Tumor that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 222 participants, roughly in line with the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target. The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04939610, a Phase 1 study of Solid Tumor, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.

RECRUITING
Registry status
Phase 1
Development phase
222 participants
Enrollment target
20
Study locations

Study 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. 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. 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.

Primary Outcome

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

Conditions Studied

Solid Tumor

Interventions

  • DRUG 68Ga-FAP-2286
  • DRUG 177Lu-FAP-2286

Study Locations (20)

California

  • City of Hope - Duarte
  • Hoag Hospital Irvine - Irvine
  • University of California Los Angeles (UCLA) - Los Angeles
  • UCSF Medical Center - San Francisco

Florida

  • Mayo Clinic - Jacksonville
  • University of Miami Hospital and Clinics - Miami

New York

  • Columbia University Medical Center - New York
  • Memorial Sloan Kettering Cancer Center - New York

Alabama

  • UAB Comprehensive Cancer Center - Birmingham

Illinois

  • University of Chicago Medical Center - Chicago

Iowa

  • University of Iowa Hospitals and Clinics - Iowa City

Michigan

  • Karmanos Cancer Institute - Detroit

Minnesota

  • Mayo Clinic - Rochester

Trial Details

FieldValue
Enrollment Target 222 participants
Start Date 2021-07-30
Est. Completion 2028-06-30
Phase Phase 1
Novartis Pharmaceuticals

1,375 total trials

What NCT04939610 shows while recruiting

NCT04939610 is an interventional study that assigns participants to a tested intervention. The registered 222 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 221-participant average among 196 other Solid Tumor trials with a reported enrollment target.

The record links to 1 condition, with Solid Tumor appearing as the primary indexed condition, and to 2 interventions - of which 68Ga-FAP-2286 is the first listed.

NCT04939610 names 20 study sites across 15 states, led by California, Florida, New York.

Frequently Asked Questions

What is clinical trial NCT04939610 about?

NCT04939610 is a clinical study titled "A Study of 177Lu-FAP-2286 in Advanced Solid Tumors". 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 mesenchy...

What is the current status of trial NCT04939610?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 222 participants. The study started on 2021-07-30. Estimated completion is 2028-06-30.

What conditions does trial NCT04939610 study?

This clinical trial studies the following conditions: Solid Tumor.

What interventions are being tested in trial NCT04939610?

The interventions under investigation include: 68Ga-FAP-2286 (DRUG), 177Lu-FAP-2286 (DRUG).

Who is sponsoring clinical trial NCT04939610?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04939610 being conducted?

This trial has 20 study locations across Alabama, California, Florida, Illinois, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Solid Tumor

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04939610's enrollment target sits among peer trials

222 33rd of 196 higher than 164 of 196 other Solid Tumor trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT04939610

Source: ClinicalTrials.gov NCT04939610, the US trial registry maintained by the National Library of Medicine. NCT04939610 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.