Evidence map›Paper›PMID 39538003›Full record

ArticleInternational journal of clinical oncology2025

Phase Ib study of the oral PI3Kδ inhibitor linperlisib in patients with advanced solid tumors.

Jin Li, Junli Xue, Tianshu Liu, Yi Feng, Nong Xu, Jianjin Huang, Yongmei Yin, Jun Zhang, Haibo Mou, Jiangzhong Shentu and 3 more

Abstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in International journal of clinical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing 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.

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

6 citing papers in PubMed.

  1. Review
  2. A renaissance in targeting the PI3K/AKT/mTOR pathway.Nature reviews. Drug discovery · 2026
    Review
  3. Article
  4. From the gene to the clinic: Key milestones in the PI3Kδ journey.Journal of immunology (Baltimore, Md. : 1950) · 2026
    Review
  5. Review
  6. Review
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

13 authors.

Jin LiDepartment of Oncology, East Hospital Affiliated to Tongji University, No. 150 Jimo Road, Pudong New Area, Shanghai, 200120, China. jili9871116@163.com.
Junli XueDepartment of Oncology, East Hospital Affiliated to Tongji University, No. 150 Jimo Road, Pudong New Area, Shanghai, 200120, China.
Tianshu LiuDepartment of Oncology, Zhongshan Hospital Affiliated to Fudan University, Shanghai, 200032, China.
Yi FengDepartment of Oncology, Zhongshan Hospital Affiliated to Fudan University, Shanghai, 200032, China.
Nong XuDepartment of Oncology, The First Affiliated Hospital of Zhejiang University, Hangzhou, 310003, China.
Jianjin HuangDepartment of Oncology, The Second Affiliated Hospital of Zhejiang University, Hangzhou, 310009, China.
Yongmei YinDepartment of Oncology, Jiangsu Provincial People's Hospital, Nanjing, 210029, China.
Jun ZhangDepartment of Oncology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.
Haibo MouDepartment of Oncology, Zhejiang Shulan Hospital, Hangzhou, 310022, China.
Jiangzhong ShentuDepartment of Pharmacology, The First Affiliated Hospital of Zhejiang University, Hangzhou, 310003, China.
Hanying BaoShanghai Yingli Pharmaceutical Co., Ltd., Shanghai, 201210, China.
Zusheng XuShanghai Yingli Pharmaceutical Co., Ltd., Shanghai, 201210, China.
Zuhong XuShanghai Yingli Pharmaceutical Co., Ltd., Shanghai, 201210, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPatients with advanced solid tumors have a suboptimal prognosis. This study investigated the safety and feasibility of linperlisib, a selective phosphatidylinositol 3-kinase delta isoform (PI3Kδ) inhibitor, for treating patients with advanced solid tumors.

methodsIn this phase Ib, single-arm, open-label, multi-center clinical trial, patients with histologically confirmed advanced solid tumors from eight centers in China were enrolled to receive oral linperlisib (80 mg/day). The primary endpoint was safety.

resultsBetween August 2019 and June 2022, 94 patients were enrolled in the trial and received the study treatment. The most common (≥ 20%) treatment emergent adverse events (TEAEs) of all grades irrespective of causality were increased aspartate aminotransferase (AST) (26.6%), proteinuria (26.6%), decreased appetite (25.5%), increased alanine aminotransferase (ALT) (22.3%), weight loss (21.3%), and anemia (21.3%). The most common grade ≥ 3 TEAEs were diarrhea (4.3%), increased AST (3.2%), increased ALT (3.2%), neutropenia (3.2%), anemia (3.2%), increased blood alkaline phosphatase (3.2%). The objective response rate (ORR) was 1.1% (95% confidence interval [CI] 0.0-5.8), and the disease control rate (DCR) was 37.2% (95% CI 27.5-47.8). As of the data cutoff, the median follow-up time was 4.2 months (95% CI 2.8-6.9). The median progression-free survival (PFS) was 1.85 months (95% CI 1.79-1.88). The median overall survival (OS) was not reached.

conclusionLinperlisib showed an acceptable safety profile and preliminary clinical benefit in patients with a range of advanced solid tumors. Further studies of linperlisib safety and efficacy are warranted.

Indexed as

NeoplasmsPhosphoinositide-3 Kinase InhibitorsPyrimidinesAdministration, OralAdultAgedChinaFemaleHumansMaleMiddle AgedPhosphoinositide-3 Kinase InhibitorsPyrimidinesAdvanced solid tumorLinperlisibPI3Kδ-selective inhibitorSafety

Identifiers

PMID39538003
PMCPMC11785675

What OpenQuestion holds

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LicenceCC BY
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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.