Evidence map›Paper›PMID 27357628›Full record

ArticleMolecular therapy : the journal of the American Society of Gene Therapy2016

Safety and Efficacy in Advanced Solid Tumors of a Targeted Nanocomplex Carrying the p53 Gene Used in Combination with Docetaxel: A Phase 1b Study.

Kathleen F Pirollo, John Nemunaitis, Po Ki Leung, Robert Nunan, Jana Adams, Esther H Chang

Open access · bronzeAbstract readClinical Trial, Phase I
In one paragraph

Article in Molecular therapy : the journal of the American Society of Gene Therapy, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed
4.9field-weighted citation impact, top 4% of its field
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

53 citing papers in PubMed, 110 citations in OpenAlex.

  1. Review
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  5. Article
  6. Antibody-Nanoparticle Conjugates in Therapy: Combining the Best of Two Worlds.Small (Weinheim an der Bergstrasse, Germany) · 2025
    Review
  7. Article
  8. Review
  9. Review
  10. Review
  11. Article
  12. Article
  13. Cell and gene therapy in neuro-oncology.Handbook of clinical neurology · 2024
    Review
  14. Article
  15. Lipid-based nucleic acid therapeutics with in vivo efficacy.Wiley interdisciplinary reviews. Nanomedicine and nanobiotechnology · 2023
    Review
  16. Article
  17. Review
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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

6 authors at 4 institutions in 1 country.

Kathleen F PirolloDepartment of Oncology, Experimental Therapeutics Division, Georgetown University Medical Center, Washington, District of Columbia, USA.
John NemunaitisMary Crowley Cancer Research Centers, Dallas, Texas, USA.
Po Ki LeungSynerGene Therapeutics, Potomac, Maryland, USA.
Robert NunanMary Crowley Cancer Research Centers, Dallas, Texas, USA.
Jana AdamsMary Crowley Cancer Research Centers, Dallas, Texas, USA.
Esther H ChangDepartment of Oncology, Experimental Therapeutics Division, Georgetown University Medical Center, Washington, District of Columbia, USA.
Georgetown University Medical Center · USMary Crowley Cancer Research Center · USAllogene Therapeutics (United States) · USGradalis (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Loss of p53 suppressor function, through mutations or inactivation of the p53 pathway, occurs in most human cancers. SGT-53 is a liposomal nanocomplex designed for systemic, tumor-targeting delivery of the wt p53 gene. In this nanodelivery system, an anti-transferrin receptor single-chain antibody fragment serves as the targeting moiety. In an initial phase 1 trial in patients with advanced solid tumors, SGT-53 demonstrated tumor-specific targeting, was shown to be well tolerated, and was associated with an antitumor effect in several patients. Our preclinical studies have also demonstrated enhanced antitumor activity with the combination of SGT-53 and docetaxel. Thus, this dose-escalation trial was undertaken to assess the combination of SGT-53 and docetaxel for safety and potential efficacy in 14 advanced cancer patients. Results reveal that the combination of SGT-53 (maximum dose, 3.6 mg DNA/infusion) and docetaxel (75 mg/m(2)/infusion) was well tolerated. Moreover, clinical activity involving 12 evaluable patients was observed. Three of these patients achieved RECIST-verified partial responses with tumor reductions of -47%, -51%, and -79%. Two others had stable disease with significant shrinkage (-25% and -16%). These results support phase 2 testing of SGT-53 in combination with docetaxel.

Indexed as

Genes, p53LiposomesAdultAgedCohort StudiesCombined Modality TherapyDocetaxelDrug Resistance, NeoplasmFemaleHumansMaleMiddle AgedNanoparticlesNeoplasm MetastasisNeoplasmsNeoplasm StagingDocetaxelLiposomesTaxoids

Identifiers

PMID27357628
PMCPMC5113104
OpenAlexW2480642725

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.