Evidence map›Paper›PMID 42390142›Full record

Trial reportThe oncologist2026

Phase 2 dose-expansion trial of OBI-3424, a DNA-alkylating prodrug, in patients with advanced solid tumors expressing AKR1C3.

Apostolia Maria Tsimberidou, Claire Verschraegen, Darren Sigal, Heinz-Josef Lenz, Howard Hochster, Mehmet A Baysal, Abhijit Chakraborty, Ingly Lee, Koenuel Ristoski, Dong Xu

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in The oncologist, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03592264 (A Phase I/II Study of OBI-3424 in Subjects with Advanced Solid Tumors), which is not on this map. Not yet cited in PubMed.

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

NCT03592264 phase1 / phase2terminatednot on this map

A Phase I/II Study of OBI-3424 in Subjects with Advanced Solid Tumors

TypeinterventionalSponsorOBI Pharma, IncRan2018 to 2024Enrolled68ConditionsSolid Tumor, Pancreatic AdenocarcinomaArmsOBI-3424
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.ORCID 0000-0003-2713-233X
Claire VerschraegenDivision of Medical Oncology, The Ohio State University Comprehensive Cancer Center, Columbus, OH, United States.
Darren SigalScripps Clinic and Scripps Cancer Center, La Jolla, CA, United States.
Heinz-Josef LenzDivision of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.ORCID 0000-0003-2178-9568
Howard HochsterRutgers Cancer Institute, New Brunswick, NJ, United States.ORCID 0000-0002-9893-1529
Mehmet A BaysalDepartment of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.
Abhijit ChakrabortyDepartment of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, TX, United States.
Ingly LeeOBI Pharma USA, Inc., San Diego, CA, United States.ORCID 0009-0009-8623-8311
Koenuel RistoskiOBI Pharma USA, Inc., San Diego, CA, United States.
Dong XuOBI Pharma USA, Inc., San Diego, CA, United States.

Funding

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

Abstract

backgroundOBI-3424 is an investigational small-molecule prodrug. In a dose-escalation trial, the OBI-3424 recommended phase 2 dose (RP2D) was 12 mg/m2 administered every 21 days. In this phase 2 dose-expansion trial, we evaluated the safety and efficacy of OBI-3424 in pancreatic adenocarcinoma and other solid tumor types ("basket" cohort).

methodsPatients with advanced solid tumors and an AKR1C3 IHC H-score of ≥ 100 were treated at the RP2D of OBI-3424. Tumor response, progression-free survival (PFS), overall survival (OS), and treatment-emergent adverse events (TEAEs) were assessed (www.clinicaltrials.gov NCT03592264).

resultsOf the 29 patients treated, 26 were evaluable for response (pancreatic adenocarcinoma, n = 10; basket cohort, n = 16). In the pancreatic adenocarcinoma cohort, stable disease (SD) was observed in 40.0% of patients, and the median PFS and OS durations were 1.35 months and 3.8 months, respectively. In the basket cohort, the objective response rate was 6.3% (1 of 16 patients had a partial response), 50% of patients had SD, and the median PFS and OS durations were 2.53 months and 5.32 months, respectively. The most common TEAEs in both cohorts were anemia, fatigue, and thrombocytopenia.

conclusionWhile OBI-3424 demonstrated a favorable safety profile, limited efficacy led to early trial termination.

Indexed as

Aldo-Keto Reductase Family 1 Member C3NeoplasmsProdrugsAdultAgedFemaleHumansMaleMiddle AgedPancreatic NeoplasmsAKR1C3 protein, humanAldo-Keto Reductase Family 1 Member C3ProdrugsefficacyOBI-3424pancreatic cancerphase 2 clinical trialsafetysolid tumors

Identifiers

PMID42390142
PMCPMC13372677

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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.