Clinical trialPhase 1Recruiting

AOH1996 for the Treatment of Refractory Solid Tumors

First in Human Phase 1 Study of AOH1996 in Patients With Refractory Solid Tumors

NCT05227326 ↗ ClinicalTrials.gov, retrieved 6 November 2026

Outcome: Ongoing
Phase: Phase 1
Status: Recruiting
Study type: Interventional
Start: 8 September 2022
Expected end: 13 September 2029
Enrollment: 92 participants
Sites: 3
Primary outcomes: Incidence of adverse events (AEs); Dose limiting toxicities
Sponsor: Other
Results posted: No
Last update: 20 October 2026

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Brief summary public domain (ClinicalTrials.gov)

This phase I trial studies the side effects and best dose of AOH1996 in treating patients with solid tumors that do not respond to treatment (refractory). AOH1996 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Detailed description public domain (ClinicalTrials.gov)

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of AOH1996. II. To establish the recommended phase 2 dose of AOH1996. III. To establish the recommended phase 2 dose of AOH1996 when given in conjunction with a TKI for NSCLC. SECONDARY OBJECTIVES: I. To determine the pharmacokinetics of AOH1996. II. To evaluate for preliminary efficacy of AOH1996. III. To evaluate response rate and disease control rate in solid tumors. EXPLORATORY OBJECTIVE: I. To determine pharmacodynamics parameters (alteration of gammaH2AX, downregulation of Myc) of AOH1996. OUTLINE: This is a dose-escalation study. Patients receive AOH1996 orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days.