NCT05227326

AOH1996 for the Treatment of Refractory Solid Tumors

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Refractory Malignant Solid Neoplasm
• Osteosarcoma
• Leiomyosarcomas
• Synovial Sarcomas
• Ovarian Cancer
• Non-Small Cell Lung Cancer
• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	PCNA Inhibitor AOH1996	Given PO

Timeline

• Start date: 2022-08-12
• Primary completion: 2029-09-13
• Completion: 2029-09-13
• First posted: 2022-02-07
• Last updated: 2025-09-18

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study