Evidence map›Paper›PMID 40557916›Full record

ArticleCancer research communications2025

Phase I First-in-Human Study of TRK-950, an IgG1 Antibody Specific to CAPRIN-1, in Patients with Advanced Solid Tumors.

Philippe A Cassier, Mitesh J Borad, Sunil Sharma, Bertrand Dubois, Christophe Caux, Fumiyoshi Okano, Daniel D Von Hoff, Jean-Yves Blay

Abstract readClinical Trial, Phase I
In one paragraph

Article in Cancer research communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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.

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

1 citing paper in PubMed.

  1. Article
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

8 authors.

Philippe A CassierDepartment of Medical Oncology, Centre Léon Bérard & Centre de Recherche en Cancérologie de Lyon (CRCL), Lyon, France.ORCID 0000-0003-3857-1688
Mitesh J BoradDepartment of Hematology-Oncology, Mayo Clinic Arizona, Mayo Clinic Comprehensive Cancer Center, Phoenix, Arizona.ORCID 0000-0003-2700-2658
Sunil SharmaHonorHealth Research Institute, Scottsdale, Arizona.ORCID 0000-0002-1308-5985
Bertrand DuboisLyon Immunotherapy for Cancer Laboratory, Centre de Recherche en Cancérologie de Lyon (CRCL) INSERM U1052-CNRS UMR5286, Centre Léon Bérard, Université Claude Bernard Lyon 1, Lyon, France.ORCID 0000-0002-7859-4975
Christophe CauxLyon Immunotherapy for Cancer Laboratory, Centre de Recherche en Cancérologie de Lyon (CRCL) INSERM U1052-CNRS UMR5286, Centre Léon Bérard, Université Claude Bernard Lyon 1, Lyon, France.ORCID 0000-0003-2438-833X
Fumiyoshi OkanoToray Industries, Inc., New Frontiers Research Laboratories, Kamakura, Japan.ORCID 0000-0002-5107-4734
Daniel D Von HoffTranslational Genomics Research Institute (TGen) A Part of City of Hope, Phoenix, Arizona.ORCID 0000-0003-4723-7681
Jean-Yves BlayDepartment of Medical Oncology, Centre Léon Bérard & Centre de Recherche en Cancérologie de Lyon (CRCL) & Université Claude Bernard Lyon 1, Lyon, France.ORCID 0000-0001-7190-120X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTRK-950 is a first-in-class humanized antibody targeting cytoplasmic activation/proliferation-associated protein-1, which is strongly expressed on the cell membrane surface in or on most solid tumors but not in or on normal tissues. This first-in-human study investigated the safety profile, pharmacokinetics (PK), and preliminary antitumor activity. PATIENTS AND

methodsPatients with treatment-refractory, locally advanced, or metastatic solid tumors were enrolled in a dose escalation/expansion study. TRK-950 was administered intravenously weekly for 3 weeks in a 28-day cycle, with doses ranging from 3 to 30 mg/kg. Dose expansion included 10 mg/kg weekly and 30 mg/kg biweekly for colorectal cancer and 10 mg/kg weekly for cholangiocarcinoma. The primary objective of this study was to determine its safety, tolerability, and maximum tolerated dose. The secondary objectives were PK, preliminary antitumor activity, and identification of potential biomarkers.

resultsThirty-six patients received at least one dose of TRK-950. In the dose escalation cohort, the maximum tolerated dose was not reached, and no dose-limiting toxicities were observed up to 30 mg/kg. Common adverse events included abdominal pain, fatigue, constipation, back pain, nausea, and decreased appetite. TRK-950 exhibited a PK profile similar to that of other IgG subclass 1 therapeutic antibodies, with linear PK parameters over the 3 to 30 mg/kg dose range. The best response was stable disease. Notably, one patient with cholangiocarcinoma showed signs of cavitation after approximately 8 months, suggesting potential antitumor activity.

conclusionsTRK-950 is safe and well tolerated, has a favorable PK profile, and should be further investigated as a monotherapy and in combination with standard treatment for various types of solid tumors. SIGNIFICANCE: TRK-950, a humanized antibody targeting CAPRIN-1, demonstrated good tolerability, no dose-limiting toxicities, a favorable PK profile, and potential antitumor activity in this first-in-human study. Currently, TRK-950 is undergoing Phase Ib and II trials for various cancers, showing promising development potential.

Indexed as

Antibodies, Monoclonal, HumanizedImmunoglobulin GNeoplasmsAdultAgedAged, 80 and overCholangiocarcinomaFemaleHumansMaleMaximum Tolerated DoseMiddle AgedAntibodies, Monoclonal, HumanizedImmunoglobulin G

Identifiers

PMID40557916
PMCPMC12246539

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Registered trials

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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.