Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2026
A Phase Ib/IIa Study of Fostrox in Combination with Lenvatinib as Second-line Therapy in Patients with Advanced Hepatocellular Carcinoma.
Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03781934 (A Phase 1/2a Study in 3 Parts to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of MIV-818 in Patients With Liver Cancer Manifestations), which is not on this map. Not yet cited in PubMed.
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A Phase 1/2a Study in 3 Parts to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of MIV-818 in Patients With Liver Cancer Manifestations
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17 authors.
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Abstract
purposeImmunotherapy has significantly improved outcomes in advanced hepatocellular carcinoma (HCC). However, most patients eventually progress, and second-line (2L) options remain limited. Fostroxacitabine bralpamide (fostrox), a liver-targeted prodrug, was administered in combination with lenvatinib, aiming at enhancing antitumor activity while avoiding further deterioration of residual liver function. PATIENTS AND
methodsThis multicenter, single-arm phase Ib/IIa study evaluated the safety, pharmacokinetics (PK)/pharmacodynamics, and efficacy of fostrox (orally for 5 days in 21-day cycles), plus lenvatinib (standard doses), in locally advanced unresectable or metastatic HCC progressed on first-line/2L therapy (NCT03781934). A 3 + 3 dose-escalation design was used to determine the recommended phase II dose (RP2D).
resultsTwenty-one patients were enrolled, and the median follow-up was 10.5 months. No dose-limiting toxicities were observed, and the RP2D of fostrox was established at 30 mg. All patients reported adverse events (AE), with 81% being grade ≥3 with possible relation to fostrox in 52.5% and to lenvatinib in 66.7% of cases. Fostrox-related AEs were mainly transient neutropenia and thrombocytopenia. Other AEs, mainly attributed to lenvatinib, were grade I/II and consistent with monotherapy use. Fostrox dose reduction and discontinuation rates were 29% and 5%, and for lenvatinib the rates were 52% and 14%, respectively. There were no signs of treatment-related liver function deterioration. The overall response rate was 24%, disease control rate was 81%, median time to progression was 10.9 months, median progression-free survival was 6.7 months, and median overall survival was 13.7 months. Fostrox PK analyses confirmed dose proportionality, and liver biopsies showed tumor-selective DNA damage.
conclusionsThe combination of fostrox and lenvatinib demonstrated promising preliminary efficacy and tolerability after immunotherapy, supporting further investigation as a 2L option in advanced HCC.
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