The oncologist · 2026
Phase 2 dose-expansion trial of OBI-3424, a DNA-alkylating prodrug, in patients with advanced solid tumors expressing AKR1C3.
СтатьяКлиническое исследование II фазыНазвание и аннотация: Перевод в очереди
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Tsimberidou Apostolia Maria, Verschraegen Claire, Sigal Darren, Lenz Heinz-Josef, Hochster Howard, Baysal Mehmet A, Chakraborty Abhijit, Lee Ingly, Ristoski Koenuel, Xu Dong
Аннотация
BACKGROUND: OBI-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).
METHODS: Patients 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).
RESULTS: Of 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.
CONCLUSION: While OBI-3424 demonstrated a favorable safety profile, limited efficacy led to early trial termination.
METHODS: Patients 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).
RESULTS: Of 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.
CONCLUSION: While OBI-3424 demonstrated a favorable safety profile, limited efficacy led to early trial termination.