Evidence map›Paper›PMID 39311947›Full record

Trial reportCancer chemotherapy and pharmacology2024

Phase I-II study of OBI-888, a humanized monoclonal IgG1 antibody against the tumor-associated carbohydrate antigen Globo H, in patients with advanced solid tumors.

Apostolia Maria Tsimberidou, Axel Grothey, Darren Sigal, Heinz-Josef Lenz, Howard S Hochster, Yee Chao, Li-Yuan Bai, Chia-Jui L Yen, Dong Xu, M Wayne Saville

Abstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Trial
  2. Review
  3. Review
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

10 authors.

Apostolia Maria TsimberidouDepartment of Investigational Cancer Therapeutics, Katherine Russell Dixie Distinguished Endowed Professor, The University of Texas MD Anderson Cancer Center, Unit 455, 1515 Holcombe Boulevard, Houston, TX, 77030, USA. atsimber@mdanderson.org.
Axel GrotheyGastrointestinal Cancer Research at West Cancer Center and Research Institute, Germantown, TN, USA.
Darren SigalScripps Clinic and Scripps Cancer Center, La Jolla, CA, USA.
Heinz-Josef LenzKeck School of Medicine, USC Norris Comprehensive Cancer Center, Los Angeles, CA, USA.
Howard S HochsterRutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA.
Yee ChaoTaipei Veterans General Hospital, Taipei, Taiwan.
Li-Yuan BaiChina Medical University Hospital, Taichung City, Taiwan.
Chia-Jui L YenNational Cheng Kung University Hospital, Tainan, Taiwan.
Dong XuOBI Pharma USA, Inc, San Diego, CA, USA.
M Wayne SavilleOBI Pharma USA, Inc, San Diego, CA, USA.

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

purposeOBI-888 is a humanized, monoclonal IgG1 antibody specific to the tumor-associated carbohydrate antigen Globo H. We conducted a phase I-II study of OBI-888 in patients with advanced cancer.

methodsPatients were treated with OBI-888 5, 10, or 20 mg/kg IV weekly in Part A ("3 + 3" design) and 20 mg/kg IV weekly in Part B (Simon's 2-stage design) (1 cycle = 28 days).

resultsOverall, 54 patients were treated (Part A, n = 14; Part B, n = 40). OBI-888 was safe and well tolerated across the doses studied, with a low incidence of OBI-888-related treatment emergent adverse events. The maximum tolerated dose of OBI-888 was not reached. No dose-limiting toxicities were noted up to the 20 mg/kg dose level (recommended phase 2 dose). Stable disease (SD) was noted in 28.6% and 20% of Parts A and B, respectively, including three patients with SD for 6+, 7+, and 9 months. Antibody-dependent cellular cytotoxicity (ADCC) was induced after each OBI-888 treatment (average increase, 3.8-fold and 4.7-fold in Parts A and B, respectively), suggesting that ADCC induction is a potential mechanism of action of OBI-888.

conclusionsOBI-888 was well tolerated. Prolonged SD was noted in three patients. ADCC was induced after each OBI-888 treatment.

Indexed as

Antibodies, Monoclonal, HumanizedNeoplasmsAdultAgedAged, 80 and overAntigens, Tumor-Associated, CarbohydrateDose-Response Relationship, DrugFemaleHumansImmunoglobulin GMaleMaximum Tolerated DoseMiddle AgedAntibodies, Monoclonal, HumanizedAntigens, Tumor-Associated, CarbohydrateImmunoglobulin GAdvanced cancerGlobo HIgG1 antibodyOBI-888

Identifiers

PMID39311947
PMCPMC11573804

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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.