Evidence map›Paper›PMID 25944802›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2015

First-in-Human Trial of a Novel Anti-Trop-2 Antibody-SN-38 Conjugate, Sacituzumab Govitecan, for the Treatment of Diverse Metastatic Solid Tumors.

Alexander N Starodub, Allyson J Ocean, Manish A Shah, Michael J Guarino, Vincent J Picozzi, Linda T Vahdat, Sajeve S Thomas, Serengulam V Govindan, Pius P Maliakal, William A Wegener and 3 more

2 registry-linked trialsAbstract readClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2015. 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. Cited by 175 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
175citing papers in PubMed, 3 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.

NCT01631552 phase1 / phase2completednot on this map

A Phase I/II Study of IMMU-132 (hRS7-SN38 Antibody Drug Conjugate) in Patients With Epithelial Cancer

TypeinterventionalSponsorGilead SciencesRan2012 to 2020Enrolled515ConditionsGastric Adenocarcinoma, Esophageal Cancer, Hepatocellular Carcinoma, Non-small Cell Lung CancerArmsSacituzumab Govitecan-hziy (SG)
NCT06065371 phase1recruitingnot on this mapstarted 2024, after this paper: background citation

Sacituzumab Govitecan in Combination With Capecitabine for Advanced Gastrointestinal Cancers After Progression on Standard Therapy

TypeinterventionalSponsorHenry Ford Health SystemRan2024 to 2027Enrolled20ConditionsGastrointestinal CancerArmsCapecitabine, Sacituzumab govetican
3 · Its place in the literature

Who cites it

175 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. A Phase II Evaluation of the Efficacy and Safety of Sacituzumab Govitecan in Patients with Recurrent Uterine Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
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  14. Article
  15. Review
  16. Article
  17. Prognostic impact of TROP2 in adenocarcinoma of the esophageal junction and stomach.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Article
  18. Review
  19. Article
  20. Review

115 more citing papers are in PubMed but not listed here.

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.

Alexander N StarodubIndiana University Health Goshen Center for Cancer Care, Goshen, Indiana.
Allyson J OceanNewYork Presbyterian Hospital/Weill Cornell Medical Center, New York, New York.
Manish A ShahNewYork Presbyterian Hospital/Weill Cornell Medical Center, New York, New York.
Michael J GuarinoChristiana Care Health System Graham Cancer Center, Newark, Delaware.
Vincent J PicozziVirginia Mason Medical Center, Seattle, Washington.
Linda T VahdatNewYork Presbyterian Hospital/Weill Cornell Medical Center, New York, New York.
Sajeve S ThomasUF Health Cancer Center, Orlando, Florida.
Serengulam V GovindanImmunomedics, Inc., Morris Plains, New Jersey.
Pius P MaliakalImmunomedics, Inc., Morris Plains, New Jersey.
William A WegenerImmunomedics, Inc., Morris Plains, New Jersey.
Steven A HamburgerImmunomedics, Inc., Morris Plains, New Jersey.
Robert M SharkeyImmunomedics, Inc., Morris Plains, New Jersey.
David M GoldenbergImmunomedics, Inc., Morris Plains, New Jersey. dmg.gscancer@att.net.

Funding

Humanized Anti-Trop2-SN-38 Conjugate For Advanced Pancreatic CancerR43CA171388 · NCI · IMMUNOMEDICS, INC. · PI WEGENER, WILLIAM A. · 2012 to 2012
$227k
NCI NIH HHS 1R43CA171388NCI NIH HHS R43 CA171388
6 · The paper itself

Abstract

purposeSacituzumab govitecan (IMMU-132) is an antibody-drug conjugate (ADC) targeting Trop-2, a surface glycoprotein expressed on many epithelial tumors, for delivery of SN-38, the active metabolite of irinotecan. This phase I trial evaluated this ADC as a potential therapeutic for pretreated patients with a variety of metastatic solid cancers. EXPERIMENTAL

designSacituzumab govitecan was administered on days 1 and 8 of 21-day cycles, with cycles repeated until dose-limiting toxicity or progression. Dose escalation followed a standard 3 + 3 scheme with 4 planned dose levels and dose delay or reduction allowed.

resultsTwenty-five patients (52-60 years old, 3 median prior chemotherapy regimens) were treated at dose levels of 8 (n = 7), 10 (n = 6), 12 (n = 9), and 18 (n = 3) mg/kg. Neutropenia was dose limiting, with 12 mg/kg the maximum tolerated dose for cycle 1, but too toxic with repeated cycles. Lower doses were acceptable for extended treatment with no treatment-related grade 4 toxicities and grade 3 toxicities limited to fatigue (n = 3), neutropenia (n = 2), diarrhea (n = 1), and leukopenia (n = 1). Using CT-based RECIST 1.1, two patients achieved partial responses (triple-negative breast cancer, colon cancer) and 16 others had stable disease as best response. Twelve patients maintained disease control with continued treatment for 16 to 36 weeks; 6 survived 15 to 20+ months. No preselection of patients based on tumor Trop-2 expression was done.

conclusionsSacituzumab govitecan had acceptable toxicity and encouraging therapeutic activity in patients with difficult-to-treat cancers. The 8 and 10 mg/kg doses were selected for phase II studies.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntigens, NeoplasmAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsCamptothecinCell Adhesion MoleculesCombined Modality TherapyDrug MonitoringFemaleHumansImmunoconjugatesMaleMiddle AgedAntibodies, Monoclonal, HumanizedAntigens, NeoplasmAntineoplastic AgentsCamptothecinCell Adhesion MoleculesImmunoconjugatessacituzumab govitecanTACSTD2 protein, human

Identifiers

PMID25944802
PMCPMC4558321

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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.