Spots Global Cancer Trial Database for AOH1996 for the Treatment of Refractory Solid Tumors

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Trial Identification

Brief Title: AOH1996 for the Treatment of Refractory Solid Tumors

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

Study ID: NCT05227326

Conditions

Refractory Malignant Solid Neoplasm

Interventions

PCNA Inhibitor AOH1996

Study Description

Brief Summary: 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: PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLT) of PCNA inhibitor AOH1996 (AOH1996). II. To establish the recommended phase 2 dose (RP2D) of AOH1996. 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.