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NCT06147037 · ClinicalTrials.gov registry record · Phase 1

A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours

A Phase 1 study of Non-Small Cell Lung Cancer and Advanced Solid Tumor, sponsored by AstraZeneca.

Recruiting
Registry status
Phase 1
Development phase
70
Enrollment target
15
Study locations

NCT06147037: Recruiting Phase 1 study of Non-Small Cell Lung Cancer and Advanced Solid Tumor, sponsored by AstraZeneca.

NCT06147037 is a Phase 1 study of Non-Small Cell Lung Cancer and Advanced Solid Tumor that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 70 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (89% lower). The trial reports 15 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06147037, a Phase 1 study of Non-Small Cell Lung Cancer and Advanced Solid Tumor, is actively recruiting participants, sponsored by AstraZeneca.

RECRUITING
Registry status
Phase 1
Development phase
70 participants
Enrollment target
15
Study locations

Study Summary

This is a first-in-human, Phase 1, non-randomized, multicenter, open-label clinical study designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics (PK) of \[225Ac\]-FPI-2068, \[111In\]-FPI-2107, and FPI-2053 in metastatic and/or recurrent solid tumors (HNSCC, NSCLC, mCRC, PDAC, GC, RCC).

Primary Outcome

Frequency, duration, and severity of AEs, DLTs, and changes in clinical, laboratory, and ECG parameters compared to baseline

Interventions

  • DRUG FPI-2053
  • DRUG [111In]-FPI-2107
  • DRUG [225Ac]-FPI-2068

Study Locations (15)

California

  • Research Site - Irvine
  • Research Site - Palo Alto
  • Research Site - Santa Monica

Quebec

  • Research Site - Montreal
  • Research Site - Sherbrooke

Illinois

  • Research Site - Chicago

Massachusetts

  • Research Site - Boston

Missouri

  • Research Site - St Louis

Nebraska

  • Research Site - Omaha

Ohio

  • Research Site - Cleveland

Pennsylvania

  • Research Site - Pittsburgh

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2024-07-31
Est. Completion 2028-05-12
Phase Phase 1
AstraZeneca

1,285 total trials

What NCT06147037 shows while recruiting

NCT06147037 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (89% lower).

The record links to 7 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which FPI-2053 is the first listed.

NCT06147037 lists 15 locations in 12 states (California, Quebec, Illinois).

Frequently Asked Questions

What is clinical trial NCT06147037 about?

NCT06147037 is a clinical study titled "A Phase 1, Dose-escalation Study of [225Ac]-FPI-2068 in Adult Patients With Advanced Solid Tumours". This is a first-in-human, Phase 1, non-randomized, multicenter, open-label clinical study designed to investigate the safety, tolerability, dosimetry, biodistribution, and pharmacokinetics (PK) of \[225Ac\]-FPI-2068, \[111In\]-FPI-2107, and FPI-2053 in metastatic and/or recurrent solid tumors (HNSCC...

What is the current status of trial NCT06147037?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2024-07-31. Estimated completion is 2028-05-12.

What conditions does trial NCT06147037 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Advanced Solid Tumor, Gastric Cancer, Head and Neck Squamous Cell Carcinoma, Renal Cell Carcinoma.

What interventions are being tested in trial NCT06147037?

The interventions under investigation include: FPI-2053 (DRUG), [111In]-FPI-2107 (DRUG), [225Ac]-FPI-2068 (DRUG).

Who is sponsoring clinical trial NCT06147037?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06147037 being conducted?

This trial has 15 study locations across California, Illinois, Massachusetts, Missouri, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Non-Small Cell Lung Cancer

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 NCT06147037's enrollment target sits among peer trials

70 289th of 454 higher than 161 of 454 other Non-Small Cell Lung Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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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Source: ClinicalTrials.gov NCT06147037, the US trial registry maintained by the National Library of Medicine. NCT06147037 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.