Evidence map›Paper›PMID 42542997›Full record

Trial reportTargeted oncology2026

FGF/FGFR Alteration Type as a Candidate Enrichment Biomarker for Gunagratinib in Recurrent or Metastatic Head and Neck Cancer: An Exploratory Analysis of Two Early-Phase Trials.

Liqiong Xue, Guopei Zhu, Peiguo Wang, Kunyu Yang, Yan Sun, Weidong Li, Zhendong Li, Cuihong Jiang, Qingqing Cai, Meiyu Fang and 5 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIClinical Trial, Phase I
PubMed Publisher
In one paragraph

Trial report in Targeted oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

NCT03758664 phase1 / phase2unknown statusnot on this map

A Phase I/IIa, Multicenter, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics of ICP-192 in Patients With Advanced Solid Malignancies

TypeinterventionalSponsorBeijing InnoCare Pharma Tech Co., Ltd.Ran2018 to 2024Enrolled56ConditionsSolid TumorArmsICP-192
NCT05372120 phase2unknown statusnot on this map

A Phase II Clinical Trial to Evaluate the Efficacy and Safety of ICP-192 in Treated Patients With Advanced Solid Tumors With FGF/FGFR Gene Alterations

TypeinterventionalSponsorBeijing InnoCare Pharma Tech Co., Ltd.Ran2021 to 2024Enrolled200ConditionsAdvanced Solid TumorArmsICP-192
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

15 authors.

Liqiong Xue *Department of Oncology, Shanghai East Hospital, School of Medicine, Tongji University, 1800 Yun Tai Road, Shanghai, 200123, China.
Guopei Zhu *Department of Oral and Maxillofacial-Head Neck Oncology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Peiguo WangDepartment of Radiotherapy, National Clinical Research Center for Cancer, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.
Kunyu YangCancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Yan SunDepartment of Radiation Oncology, Beijing Cancer Hospital and Beijing Institute for Cancer Research, Key Laboratory of Carcinogenesis and Translational Research, Ministry of Education, Beijing, China.
Weidong LiAffiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, China.
Zhendong LiLiaoning Cancer Hospital and Institute, Shenyang, China.
Cuihong JiangDepartment of Radiation Oncology, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University/Hunan Cancer Hospital, Changsha, China.
Qingqing CaiDepartment of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China.
Meiyu FangZhejiang Cancer Hospital, Hangzhou, China.
Man HuDepartment of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.
Minghua GeOtolaryngology and Head and Neck Center, Cancer Center, Department of Head and Neck Surgery, Zhejiang Provincial People's Hospital (Affiliated People's Hospital), Hangzhou Medical College, Hangzhou, China.
Wei ZhouBeijing InnoCare Pharma Tech Co., Ltd., Beijing, China.
Sichen LiBeijing InnoCare Pharma Tech Co., Ltd., Beijing, China.
Ye GuoDepartment of Oncology, Shanghai East Hospital, School of Medicine, Tongji University, 1800 Yun Tai Road, Shanghai, 200123, China. pattrickguo@gmail.com.ORCID http://orcid.org/0000-0002-1813-9815

Funding

Beijing Xisike Clinical Oncology Research Foundation Y-Young2024-0414Shanghai Pudong New Area Health Commission PW2023A-11
6 · The paper itself

Abstract

backgroundFGF/FGFR alterations are recurrent but heterogeneous in head and neck cancer, and which types predict benefit from selective fibroblast growth factor receptor (FGFR) inhibition is unknown.

objectiveWe examined whether response to gunagratinib, a pan-FGFR1-4 inhibitor, differs by FGF/FGFR alteration type in recurrent or metastatic head and neck cancer.

methodsPatients with recurrent or metastatic head and neck cancer and fibroblast growth factor(FGF)/FGFR alterations treated with gunagratinib in two prospective trials were combined (phase I ICP-CL-00301, n = 10; phase IIa ICP-CL-00304 at the recommended phase II dose [RP2D] of 20 mg once daily, n = 27). Confirmed objective response rate (Response Evaluation Criteria in Solid Tumours [RECIST] Version 1.1, investigator assessed) was the primary endpoint. Exploratory analyses examined efficacy by alteration type, with an RP2D sensitivity analysis and post-hoc CCND1 outcomes.

resultsAmong 37 patients (23 head and neck squamous cell carcinoma, 9 nasopharyngeal carcinoma, 5 other; 78.4% with three or more prior therapy lines), confirmed the objective response rate at the RP2D (n = 27) was 7.4% (95% confidence interval 0.9-24.3) and disease control rate 55.6%, with no responses among FGFR-mutant patients (0/6) and single responses among fusions (1/2) and amplifications (1/6). In the pooled cohort (N = 37, including ten treated at sub-RP2D doses), objective response rate was 13.5% (95% confidence interval 4.5-28.8), disease control rate 56.8%, median progression-free survival 4.1 months, median duration of response 11.0 months and median overall survival 7.4 months. Four of five responses arose in receptor-level FGFR alterations rather than FGF3/4/19 amplification alone; because both mutation responses occurred at sub-RP2D doses, this pattern is hypothesis generating. Grade ≥3 treatment-related adverse events occurred in 35.1%, most commonly hyperphosphataemia; no treatment-related deaths occurred.

conclusionsAt the RP2D, gunagratinib monotherapy had limited activity (0/6 among FGFR-mutant tumours). In the pooled cohort, confirmed responses concentrated among FGFR receptor-level alterations rather than the FGF3/4/19-amplified majority; because part of this signal came from sub-RP2D dosing, alteration type is a candidate enrichment criterion requiring prospective RP2D testing. CLINICAL

trial registrationClinicalTrials.gov, NCT03758664 (registered 29 November, 2018) and NCT05372120 (registered 12 May, 2022, retrospectively).

Indexed as

Biomarkers, TumorFibroblast Growth FactorsHead and Neck NeoplasmsNeoplasm Recurrence, LocalReceptors, Fibroblast Growth FactorAgedFemaleHumansMaleMiddle AgedNeoplasm MetastasisBiomarkers, TumorFibroblast Growth FactorsReceptors, Fibroblast Growth Factor

Identifiers

PMID42542997

What OpenQuestion holds

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Registered trials

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.