Evidence map›Paper›PMID 40481574›Full record

Trial reportJournal of hematology & oncology2025

Results of a phase 1/2 study of sacituzumab tirumotecan in patients with unresectable locally advanced or metastatic solid tumors refractory to standard therapies.

Quchang Ouyang, Jordi Rodon, Yan Liang, Xinhong Wu, Qun Li, Lihua Song, Min Yan, Zhongsheng Tong, YunPeng Liu, Zev A Wainberg and 18 more

Registry-linked trialAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of hematology & oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04152499 (A Phase I-II, First-in-Human Study of SKB264 in Patients With Locally Advanced Unresectable /Metastatic Solid Tumors Who Are Refractory to Available Standard Therapies), which is not on this map. Cited by 16 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 1 pooled it
–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.

NCT04152499 phase1 / phase2active not recruitingnot on this map

A Phase I-II, First-in-Human Study of SKB264 in Patients With Locally Advanced Unresectable /Metastatic Solid Tumors Who Are Refractory to Available Standard Therapies

TypeinterventionalSponsorKlus Pharma Inc.Ran2020 to 2026Enrolled1,410ConditionsEpithelial Ovarian Cancer, Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Urothelial CarcinomaArmsSKB264
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  15. Current landscape of sequencing ADCs in metastatic breast cancer.Therapeutic advances in medical oncology · 2025
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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

28 authors.

Quchang Ouyang *Hunan Cancer Hospital, Changsha, China.
Jordi Rodon *University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Yan Liang *Jiangsu Province Hospital, 300 Guangzhou Road, Nanjing, 210029, China.
Xinhong WuHubei Cancer Hospital, Wuhan, China.
Qun LiShanghai East Hospital, Shanghai, China.
Lihua SongShandong Cancer Hospital, Jinan, China.
Min YanThe Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital, Zhengzhou, China.
Zhongsheng TongTianjin Cancer Hospital, Tianjin, China.
YunPeng LiuThe First Hospital of China Medical University, Shenyang, China.
Zev A WainbergUCLA University of California Los Angeles, Santa Monica, CA, USA.
Ying WangSun Yai-Sen Memorial Hospital, Guangzhou, China.
Cuizhi GengThe Fourth Hospital of Hebei Medical University, Shijiazhuang, China.
Susanna V UlahannanStephenson Cancer Center, University of Oklahoma/SCRI, Oklahoma City, OK, USA.
Guohua YuWeifang People's Hospital, Weifang, China.
Manish R SharmaSTART Center for Cancer Research - Midwest, Grand Rapids, MI, USA.
Xiang WangXuzhou Central Hospital, Xuzhou, China.
Judy S WangFlorida Cancer Specialists/Sarah Cannon Research Institute, Sarasota, FL, USA.
Alexander SpiraVirginia Cancer Specialists (Fairfax), Fairfax, VA, USA.
Weihong ZhaoChinese PLA General Hospital, Beijing, China.
Rachel E SanbornEarle A. Chiles Research Institute, Providence Cancer Institute, Portland, OR, USA.
Ying ChengJilin Cancer Hospital, Changchun, China.
Xian WangSir Run Run Shaw Hospital Zhejiang University School of Medicine, Hangzhou, China.
Gesha LiuSichuan Kelun-Biotech Biopharmaceutical Co., Ltd., Chengdu, China.
Yaling LiSichuan Kelun-Biotech Biopharmaceutical Co., Ltd., Chengdu, China.
Junyou GeSichuan Kelun-Biotech Biopharmaceutical Co., Ltd., Chengdu, China.
Elliot ChartashMerck & Co., Inc., Rahway, NJ, USA.
Omobolaji O AkalaMerck & Co., Inc., Rahway, NJ, USA.
Yongmei YinJiangsu Province Hospital, 300 Guangzhou Road, Nanjing, 210029, China. ym.yin@hotmail.com.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSacituzumab tirumotecan (sac-TMT) is an antibody-drug conjugate composed of an anti-TROP2 monoclonal antibody coupled to a cytotoxic belotecan-derived topoisomerase I inhibitor (KL610023) via a novel linker. We report results from the phase 1 dose-escalation cohorts in advanced solid tumors and phase 2 expansion cohorts for metastatic triple-negative breast cancer (TNBC) from the first-in-human MK-2870-001 (KL264-01) study (NCT04152499).

methodsPatients had unresectable locally advanced/metastatic solid tumors refractory to standard therapies. In the phase 1 dose-escalation cohorts, patients had unresectable locally advanced/metastatic solid tumors refractory to standard therapies. Sac-TMT was administered by intravenous administration every 2 weeks at 2 to 12 mg/kg. In phase 2, patients with TNBC and HR+/HER2- breast cancer received sac-TMT per recommended doses for expansion (RDEs) identified in phase 1. Primary objectives were determining maximum tolerated dose (MTD) of sac-TMT and establishing RDEs (phase 1) and determining ORR per RECIST v1.1 by investigator assessment (phase 2). Adverse events were assessed per NCI-CTCAE version 5.0.

resultsThirty patients were enrolled in phase 1 and received sac-TMT 2 mg/kg (n = 4), 4 mg/kg (n = 7), 5 mg/kg (n = 7), 5.5 mg/kg (n = 5), and 6 mg/kg (n = 7). Five patients had dose-limiting toxicities: grade 3 stomatitis at 4, 5.5, and 6 mg/kg; grade 3 rash at 5 mg/kg; and grade 3 urticaria at 6 mg/kg. MTD was 5.5 mg/kg and RDEs were 4 and 5 mg/kg. In the phase 2 dose expansion, ORR (95% CI) was 34.8% (16.4%, 57.3%) in the 4-mg/kg group (n = 23) and 38.9% (23.1%, 56.5%) in the 5-mg/kg group (n = 36) for TNBC. ORR (95% CI) was 31.7% (18.1%, 48.1%) for HR+/HER2- breast cancer (n = 41).

conclusionsSac-TMT demonstrated manageable safety profile in patients with unresectable locally advanced/metastatic solid tumors and promising antitumor activity in metastatic TNBC and HR+/HER2 - breast cancer. Sac-TMT is being investigated in phase 3 studies.

trial registrationClinicalTrials.gov, NCT04152499.

Indexed as

Antibodies, BispecificAntibodies, Monoclonal, HumanizedImmunoconjugatesNeoplasmsTriple Negative Breast NeoplasmsAdultAgedAged, 80 and overCamptothecinFemaleHumansMaleMaximum Tolerated DoseMiddle AgedNeoplasm MetastasisAntibodies, BispecificAntibodies, Monoclonal, HumanizedCamptothecinImmunoconjugatessacituzumab govitecanAntibody–drug conjugateHR+/HER2− breast cancerSac-TMTTriple-negative breast cancer

Identifiers

PMID40481574
PMCPMC12142944

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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 Socratic graph.