Evidence map›Paper›PMID 39418340›Full record

ArticleThe oncologist2025

Phase Ib study of anti-PD-L1 monoclonal antibody socazolimab in combination with nab-paclitaxel as first-line therapy for advanced urothelial carcinoma.

Bixia Tang, Jun Xiao, Zhihong Chi, Rong Duan, Chuanliang Cui, Lu Si, Yixun Liu, Xuechun Hu, Zhi Liu, Ping Xiang and 10 more

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in The oncologist, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04603846 (A Study of Anti-PD-L1 Antibody ZKAB001 Combined With Albumin-bound Paclitaxel in Advanced Urothelial Carcinoma), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT04603846 phase1unknown statusnot on this map

A Study of Anti-PD-L1 Antibody ZKAB001 Combined With Albumin-bound Paclitaxel in Advanced Urothelial Carcinoma

TypeinterventionalSponsorLee's Pharmaceutical LimitedRan2020 to 2023Enrolled20ConditionsAdvanced Urothelial CarcinomaArmsanti-PD-L1 antibody, albumin bound paclitaxel
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
  2. The Role of Natural Compounds in Bladder Urothelial Carcinoma Treatment.International journal of molecular sciences · 2026
    Review
  3. 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

20 authors.

Bixia TangKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Melanoma and Soft Tissue Sarcoma, Peking University Cancer Hospital & Institute, Beijing, People's Republic of China.ORCID 0000-0002-3458-461X
Jun XiaoDepartment of Urology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People's Republic of China.
Zhihong ChiKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Melanoma and Soft Tissue Sarcoma, Peking University Cancer Hospital & Institute, Beijing, People's Republic of China.
Rong DuanKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Genitourinary Oncology, Peking University Cancer Hospital & Institute, Beijing, People's Republic of China.
Chuanliang CuiKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Genitourinary Oncology, Peking University Cancer Hospital & Institute, Beijing, People's Republic of China.
Lu SiKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Melanoma and Soft Tissue Sarcoma, Peking University Cancer Hospital & Institute, Beijing, People's Republic of China.ORCID 0000-0002-2123-9761
Yixun LiuDepartment of Urology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People's Republic of China.
Xuechun HuDepartment of Urology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People's Republic of China.
Zhi LiuDepartment of Urology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People's Republic of China.
Ping XiangDepartment of Urology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, Anhui, People's Republic of China.
Siming LiKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Genitourinary Oncology, Peking University Cancer Hospital & Institute, Beijing, People's Republic of China.
Xieqiao YanKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Genitourinary Oncology, Peking University Cancer Hospital & Institute, Beijing, People's Republic of China.
Li ZhouKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Genitourinary Oncology, Peking University Cancer Hospital & Institute, Beijing, People's Republic of China.ORCID 0000-0002-9331-0600
Juan LiKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Genitourinary Oncology, Peking University Cancer Hospital & Institute, Beijing, People's Republic of China.
Yujie LiZhaoke (Guangzhou) Oncology Pharmaceutical Limited, Guangzhou 511400, People's Republic of China.
Xiaohui YuZhaoke (Guangzhou) Oncology Pharmaceutical Limited, Guangzhou 511400, People's Republic of China.
Xiangrong DaiZhaoke (Guangzhou) Oncology Pharmaceutical Limited, Guangzhou 511400, People's Republic of China.
Xiaoyi LiZhaoke (Guangzhou) Oncology Pharmaceutical Limited, Guangzhou 511400, People's Republic of China.
Jun GuoKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Genitourinary Oncology, Peking University Cancer Hospital & Institute, Beijing, People's Republic of China.
Xinan ShengKey Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Genitourinary Oncology, Peking University Cancer Hospital & Institute, Beijing, People's Republic of China.ORCID 0000-0001-9359-0975

Funding

Oncology Pharmaceutical Limited
6 · The paper itself

Abstract

backgroundPD-1/PD-L1 immune checkpoint inhibitors (ICIs) have demonstrated activity in the post-platinum and platinum-ineligible settings for advanced urothelial carcinoma (aUC). As only around 50% of patients with aUC can tolerate platinum-containing treatment, treatments combining first-line ICIs with non-platinum drugs are urgently needed. Therefore, we assessed the safety and efficacy of the anti-PD-L1 monoclonal antibody Socazolimab in combination with nab-paclitaxel as first-line therapy in aUC (NCT04603846).

methodsThis was a multi-center, single-arm, phase Ib study that enrolled patients with treatment-naive aUC. Patients received Socazolimab (5 mg/kg) and nab-paclitaxel (260 mg/m2) Q3w. The primary endpoint was safety and tolerability of the combination regimen. Second endpoints were the objective response rate (ORR) and progression-free survival.

resultsBetween September, 2020 and September, 2021, 20 patients with urothelial carcinoma were enrolled, arising from renal pelvis (5), bladder (8), and ureter (7). After a median follow-up of 17 months, the median number of treatment cycles was 12. No patients had dose limiting toxicity. All patients had treatment-related adverse events (TRAEs), most of which were grade 1 or 2. The common TRAEs (≥20%) were peripheral neurotoxicity, alopecia, rash, increased ALT, weight loss, weakness, pruritus, increased AST, increased γGT, increased ALP, neutropenia, emesis, and anorexia. Nine patients (45%) developed grade 3 TRAEs including peripheral neurotoxicity (30.0%), increased ALT (10.0%), and increased γGT (5.0%). Two patients (10%) discontinued treatment because of grade 3 mouth ulcer (n = 1) and grade 2 lung fibrosis (n = 1). No grade 4-5 TRAEs were observed. Among the 17 patients who had received at least one tumor assessment, ORR was 58.8% (95% CI, 32.9%-81.6%) and the median progression-free survival was 8.3 months (95% CI, 5.2-19.5). The median duration of response was 13.3 months (95% CI, 2.0-20.1), and the overall survival was 19.5 months (95% CI, 11.2-not reached).

conclusionSocazolimab combined with nab-paclitaxel has shown good safety and promising antitumor activity as first-line therapy in patients with advanced urothelial carcinoma.

Indexed as

AlbuminsAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Transitional CellPaclitaxelUrologic NeoplasmsAgedAged, 80 and overB7-H1 AntigenFemaleHumansMaleMiddle AgedUrinary Bladder Neoplasms130-nm albumin-bound paclitaxelAlbuminsAntibodies, Monoclonal, HumanizedB7-H1 AntigenCD274 protein, humanPaclitaxeladvanced urothelial carcinomaanti-PD-L1 antibodychemoimmunotherapy combinationfirst-linenab-paclitaxelsocazolimab

Identifiers

PMID39418340
PMCPMC11883152

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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.