Evidence map›Paper›PMID 38218979›Full record

ArticleCommunications medicine2024

First-in-human phase I dose escalation trial of the first-in-class tumor microenvironment modulator VT1021 in advanced solid tumors.

Devalingam Mahalingam, Wael Harb, Amita Patnaik, Andrea Bullock, Randolph S Watnick, Melanie Y Vincent, Jian Jenny Chen, Suming Wang, Harold Pestana, Judy Chao and 3 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Communications medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03364400 (A Phase 1 Study Evaluating the Safety, Pharmacology, and Preliminary Activity of VT1021 in Patients With Advanced Solid Tumors), which is not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
5.8field-weighted citation impact, top 3% 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.

NCT03364400 phase1unknown statusnot on this map

A Phase 1 Study Evaluating the Safety, Pharmacology, and Preliminary Activity of VT1021 in Patients With Advanced Solid Tumors

TypeinterventionalSponsorVigeo Therapeutics, Inc.Ran2017 to 2024Enrolled116ConditionsSolid TumorArmsVT1021
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 24 citations in OpenAlex.

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  2. Advances in Lipid Metabolism Reprogramming in Hepatocellular Carcinoma.Journal of clinical and translational hepatology · 2026
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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

13 authors at 6 institutions in 1 country.

Devalingam MahalingamNorthwestern University Medical School, Chicago, IL, USA. Mahalingam@nm.org.ORCID http://orcid.org/0000-0002-2979-9894
Wael HarbHorizon Oncology Center, Lafayette, IN, USA.
Amita PatnaikSouth Texas Accelerated Research Therapeutics, San Antonio, TX, USA.
Andrea BullockBeth Israel Deaconess Hospital, Boston, MA, USA.ORCID http://orcid.org/0000-0001-7143-0225
Randolph S WatnickBoston Children's Hospital, Boston, MA, USA.
Melanie Y VincentVigeo Therapeutics, Cambridge, MA, USA.
Jian Jenny ChenVigeo Therapeutics, Cambridge, MA, USA.ORCID http://orcid.org/0009-0003-3598-8047
Suming WangVigeo Therapeutics, Cambridge, MA, USA.
Harold PestanaVigeo Therapeutics, Cambridge, MA, USA.
Judy ChaoVigeo Therapeutics, Cambridge, MA, USA.
James MahoneyVigeo Therapeutics, Cambridge, MA, USA.
Michael CieslewiczVigeo Therapeutics, Cambridge, MA, USA.
Jing WatnickVigeo Therapeutics, Cambridge, MA, USA. Jing.Watnick@vigeotx.com.ORCID http://orcid.org/0000-0003-0475-3299
Beth Israel Deaconess Hospital · USBoston Children's Hospital · USHorizon Oncology Center · USNorthwestern University · USSage Therapeutics (United States) · USSouth Texas Accelerated Research Therapeutics · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVT1021 is a cyclic peptide that induces the expression of thrombospondin-1 (TSP-1) in myeloid-derived suppressor cells (MDSCs) recruited to the tumor microenvironment (TME). TSP-1 reprograms the TME via binding to CD36 and CD47 to induce tumor and endothelial cell apoptosis as well as immune modulation in the TME.

methodsStudy VT1021-01 (ClinicalTrials.gov ID NCT03364400) used a modified 3 + 3 design. The primary objective was to determine the recommended Phase 2 dose (RP2D) in patients with advanced solid tumors. Safety, tolerability, and pharmacokinetics (PK) were assessed. Patients were dosed twice weekly intravenously in 9 cohorts (0.5-15.6 mg/kg). Safety was evaluated using CTCAE version 5.0 and the anti-tumor activity was evaluated by RECIST version 1.1.

resultsThe RP2D of VT1021 is established at 11.8 mg/kg. VT1021 is well tolerated with no dose-limiting toxicities reported (0/38). The most frequent drug-related adverse events are fatigue (15.8%), nausea (10.5%), and infusion-related reactions (10.5%). Exposure increases proportionally from 0.5 to 8.8 mg/kg. The disease control rate (DCR) is 42.9% with 12 of 28 patients deriving clinical benefit including a partial response (PR) in one thymoma patient (504 days).

conclusionsVT1021 is safe and well-tolerated across all doses tested. RP2D has been selected for future clinical studies. PR and SD with tumor shrinkage are observed in multiple patients underscoring the single-agent potential of VT1021. Expansion studies in GBM, pancreatic cancer and other solid tumors at the RP2D have been completed and results will be communicated in a separate report.

Identifiers

PMID38218979
PMCPMC10787778
OpenAlexW4390841330

What OpenQuestion holds

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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.