Evidence map›Paper›PMID 36622048›Full record

ArticleCancer medicine2023

Phase 1 dose escalation study of FGFR4 inhibitor in combination with pembrolizumab in advanced solid tumors patients.

Jianming Xu, Jiuwei Cui, Haiping Jiang, Yan Zeng, Xiuyu Cong

Open access · goldAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Cancer medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.5field-weighted citation impact, top 35% 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

4 citing papers in PubMed, 3 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Article
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

5 authors at 4 institutions in 1 country.

Jianming XuOncology Department, Chinese PLA General Hospital, Beijing, China.ORCID 0000-0003-4467-6021
Jiuwei CuiOncology Department, The First Hospital of Jilin University, Changchun, China.ORCID 0000-0002-1664-9491
Haiping JiangOncology Department, The First Affiliated Hospital of Zhejiang University, Hangzhou, China.
Yan ZengEverNov Medicines (Zhuhai Hengqin) Co., Ltd, Zhuhai, China.
Xiuyu CongEverNov Medicines (Zhuhai Hengqin) Co., Ltd, Zhuhai, China.
Zhuhai Institute of Advanced Technology · CNChinese PLA General Hospital · CNFirst Affiliated Hospital Zhejiang University · CNJilin University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveInhibition of fibroblast growth factor (FGF) 19-FGF Receptor 4 (FGFR4) signaling demonstrates potent anticancer activity. EVER4010001 is a highly selective FGFR4 inhibitor and pembrolizumab is approved for the treatment of several solid tumors. This study determined the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D), pharmacokinetics, safety, and preliminary efficacy of EVER4010001 plus pembrolizumab in patients with advanced solid tumors.

methodsThis Phase 1, multicenter, open-label study enrolled 19 Asian-Chinese patients (57.9% male: median age 58 years) with advanced solid tumors. For "3+3" dose escalation, 3-6 patients received treatment at each dose level (EVER4010001 40, 60, 80, or 100 mg twice daily [BID] plus pembrolizumab 200 mg every 3 weeks).

resultsAt the data cutoff (August 12, 2021), no dose-limiting toxicities (DLTs) were reported at 40 mg-80 mg. At 100 mg, 2 (40.0%) patients had 3 DLTs within the 28-day DLT observation period after first administration. Median time to peak EVER4010001 concentration (T

conclusionEighty milligrams BID was the MTD and RP2D for EVER4010001 plus pembrolizumab. Efficacy results were promising, and no new safety risks were reported, justifying the Phase 2 portion of this study.

Indexed as

NeoplasmsAntibodies, Monoclonal, HumanizedFemaleHumansMaleMaximum Tolerated DoseMiddle AgedReceptor, Fibroblast Growth Factor, Type 4Antibodies, Monoclonal, HumanizedFGFR4 protein, humanpembrolizumabReceptor, Fibroblast Growth Factor, Type 4FGF19FGFR4pembrolizumabPhase 1solid tumor

Identifiers

PMID36622048
PMCPMC10134273
OpenAlexW4313829724

What OpenQuestion holds

Textmetadata
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.