Last reviewed 2026-04-19 · How we verify

ABIVERTINIB

Abivertinib is being studied in trials for prostate cancer and in hospitalized patients to assess its safety and how the body processes it.

Abivertinib is a drug being studied in combination with abiraterone for metastatic castration-resistant prostate cancer, and also for safety and efficacy in hospitalized patients. Clinical trials are also investigating its absorption, metabolism, and excretion. It is being studied as STI-5656 (Abivertinib Maleate).

At a glance

Mechanism of action

Abivertinib is being investigated in clinical trials to understand how it works in the body and whether it can help treat certain conditions. Studies are looking at how the drug is absorbed, broken down, and removed from the body. These trials also assess the drug's safety and how well it works in patients with specific illnesses.

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• An Open-Label, Non-Randomized, Single-Center Study to Preliminary Evaluation of Safety and Efficacy of Patients Who Participant in [14C] AC0010 Trail and Subsequent Receiving AC0010 Treatment (Phase 1)
• An Open-label, Multi-center, Phase II Umbrella Study to Assess Efficacy of Targeted Therapy or Immunotherapy Directed by Next Generation Sequencing (NGS) in Chinese Patients With Advanced NSCLC (TRUMP (Phase 2)
• A Phase I, Multicenter, Open-Label Safety, Pharmacokinetic and Preliminary Efficacy Study of Wild-type Sparing EGFR Inhibitor, AC0010MA, in Adult Patients With Previously Treated EGFRmut and Acquired (Phase 1)
• An Open-Label, Non-Randomized, Single-Center Study to Determine the Absorption, Metabolism and Excretion of A Single Dose [14C] AC0010 in Patients With Advanced NSCLC (Phase 1)
• A Phase 2, Randomized, Double-Blind, Placebo-controlled Study of the Safety and Efficacy of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized Due to COVID-19 (Phase 2)
• A Phase III, Open-Label, Randomized Multicenter Study to Compare AC0010 and Pemetrexed/Cisplatin in Patients With Advanced NSCLC Who Have Progressed Following Prior EGFR TKI (Phase 3)
• A Randomized Controlled, Double-blind, Multicenter, Phase III Clinical Study to Compare Efficacy and Safety of Abivertinib Maleate Versus First-line Standard Therapy EGFR-TKI in Patients With Advanced (Phase 3)
• Single-arm,Multi-center,Phase II Clinical Trial of the Efficacy and Safety of AC0010 in the Treatment of EGFR T790M Mutation-positive Patients With Advanded NSCLC (Phase 2)

Primary sources

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