Evidence map›Paper›PMID 37174019›Full record

ArticleCancers2023

A Multicenter, Open-Label, Phase I/II Study of FN-1501 in Patients with Advanced Solid Tumors.

Gary Edward Richardson, Raed Al-Rajabi, Dipesh Uprety, Anis Hamid, Stephen K Williamson, Joaquina Baranda, Hirva Mamdani, Ya-Li Lee, Nitika, Li Li and 2 more

Open access · goldAbstract read
In one paragraph

Article in Cancers, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.9field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 3 citations in OpenAlex.

  1. Review
  2. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 3 institutions in 2 countries.

Gary Edward RichardsonCabrini Health, Malvern, VIC 3144, Australia.
Raed Al-RajabiUniversity of Kansas Cancer Center, Kansas City, KS 64114, USA.
Dipesh UpretyBarbara Ann Karmanos Cancer Institute, Department of Oncology, Wayne State University School of Medicine, Detroit, MI 48201, USA.
Anis HamidCabrini Health, Malvern, VIC 3144, Australia.
Stephen K WilliamsonUniversity of Kansas Cancer Center, Kansas City, KS 64114, USA.ORCID 0000-0003-4118-1242
Joaquina BarandaUniversity of Kansas Cancer Center, Kansas City, KS 64114, USA.ORCID 0000-0002-0917-6307
Hirva MamdaniBarbara Ann Karmanos Cancer Institute, Department of Oncology, Wayne State University School of Medicine, Detroit, MI 48201, USA.ORCID 0000-0003-3874-8703
Ya-Li LeeFosun Pharma USA, Princeton, NJ 08540, USA.
NitikaFosun Pharma USA, Princeton, NJ 08540, USA.ORCID 0000-0001-8456-3553
Li LiFosun Pharma USA, Princeton, NJ 08540, USA.
Xingli WangFosun Pharma USA, Princeton, NJ 08540, USA.
Xunwei DongFosun Pharma USA, Princeton, NJ 08540, USA.
The University of Kansas Cancer Center · USCabrini Hospital · AUWayne State University · US

Funding

Fosun Pharma USA N/A
6 · The paper itself

Abstract

backgroundFN-1501, a potent inhibitor of receptor FMS-like tyrosine kinase 3 (

methodsPts received FN-1501 IV three times a week for 2 weeks, followed by 1 week off treatment in continuous 21-day cycles. Dose escalation followed a standard 3 + 3 design. Primary objectives include the determination of the maximum tolerated dose (MTD), safety, and recommended Phase 2 dose (RP2D). Secondary objectives include pharmacokinetics (PK) and preliminary anti-tumor activity. Exploratory objectives include the relationship between pharmacogenetic mutations (e.g.,

resultsA total of 48 adult pts with advanced solid tumors (N = 47) and AML (N = 1) were enrolled at doses ranging from 2.5 to 226 mg IV three times a week for two weeks in 21-day cycles (2 weeks on and 1 week off treatment). The median age was 65 years (range 30-92); 57% were female and 43% were male. The median number of prior lines of treatment was 5 (range 1-12). Forty patients evaluable for dose-limiting toxicity (DLT) assessment had a median exposure of 9.5 cycles (range 1-18 cycles). Treatment-related adverse events (TRAEs) were reported for 64% of the pts. The most common treatment-emergent adverse events (TEAEs), defined as those occurring in ≥20% of pts, primarily consisted of reversible Grade 1-2 fatigue (34%), nausea (32%), and diarrhea (26%). The most common Grade ≥3 events occurring in ≥5% of pts consisted of diarrhea and hyponatremia. Dose escalation was discontinued due to DLTs of Grade 3 thrombocytopenia (N = 1) and Grade 3 infusion-related reaction (N = 1) occurring in 2 pts. The maximum tolerated dose (MTD) was determined to be 170 mg.

conclusionsFN-1501 demonstrated reasonable safety, tolerability, and preliminary activity against solid tumors in doses up to 170 mg. Dose escalation was terminated based on 2 DLTs occurring at the 226 mg dose level.

Indexed as

AMLFLT3 inhibitorFN-1501Phase I/IIsolid tumors

Identifiers

PMID37174019
PMCPMC10177510
OpenAlexW4368377560

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.