What question did this study set out to answer?

This trial aims to assess the safety and efficacy of OBI-3424 in treating advanced solid tumors with AKR1C3 expression.

July 4, 2026The OncologistOpen Access

Phase 2 Dose Expansion Trial of OBI-3424, a DNA-Alkylating Prodrug, in Patients with Advanced Solid Tumors Expressing AKR1C3

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Randomized trial evaluates safety and efficacy of OBI-3424 in advanced solid tumors, suggesting limited effectiveness.

This trial aims to assess the safety and efficacy of OBI-3424 in treating advanced solid tumors with AKR1C3 expression.
Conducted phase 2 dose-expansion trial with a recommended phase 2 dose of 12 mg/m2 every 21 days.
Patients with advanced solid tumors and AKR1C3 IHC H-score ≥ 100 were treated and monitored for tumor response, progression-free survival (PFS), and overall survival (OS).
29 patients were treated; 26 were evaluable for response.
In the pancreatic adenocarcinoma cohort, 40% had stable disease, with median PFS of 1.35 months and OS of 3.8 months.
In the basket cohort, the objective response rate was 6.3%, with 50% having stable disease, median PFS of 2.53 months, and OS of 5.32 months.
The most common treatment-emergent adverse events were anemia, fatigue, and thrombocytopenia.

Tsimberidou et al. (2026) studied this question.

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