Actively Recruiting
First in Human Phase 1 Study of AOH1996 for Treatment of Refractory Solid Tumors
Led by City of Hope Medical Center · Updated on 2025-09-18
92
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating AOH1996, an investigational drug, in patients with solid tumors that have not responded to standard treatments. This phase I trial aims to find the highest safe dose, understand side effects, and explore early signs of how well AOH1996 works. The study also looks at how the drug behaves in the body and examines its effects when combined with another treatment for certain lung cancers. Participants receive AOH1996 by mouth twice daily for 28-day cycles, continuing until the cancer progresses or side effects become unacceptable. The study includes a dose-escalation phase to determine the best dose for future research, including a part that combines AOH1996 with a tyrosine kinase inhibitor for lung cancer patients. After treatment ends, participants are monitored for 30 days. During the trial, researchers track side effects and dose-limiting toxicities within the first cycle and follow participants for up to two years to assess response rates, disease control, progression-free survival, overall survival, and time to treatment failure. Participants will undergo various assessments including laboratory tests and evaluations of tumor response. Safety is closely monitored throughout the study and during follow-up periods.
CONDITIONS
Brief Title
AOH1996 for the Treatment of Refractory Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented informed consent by the participant
- Willingness to allow use of archival tissue if existing
- Age 18 years or older
- ECOG performance status 2 or lower
- Life expectancy greater than 3 months
- Solid tumors failing standard therapies or refusing standard treatments (except stable NSCLC on EGFR TKI for at least 2 months in Part B)
- Agreement to use adequate birth control or abstain from heterosexual activity during study and 30 days after
- ANC of at least 1,500/mm3
- Platelets of at least 100,000/mm3
- Total serum bilirubin less than or equal to 1.5 times upper limit of normal
- AST and ALT less than or equal to 1.5 times upper limit of normal (or up to 3 times with liver metastases)
- Creatinine clearance of at least 60 mL/min
- Negative pregnancy test for women of childbearing potential
You will not qualify if you...
- Use of dietary or herbal supplements
- Use of other investigational products or chemotherapy (except EGFR TKI in NSCLC cohort)
- Use of warfarin
- Use of agents contraindicated with strong CYP3A4 inducers
- Use of strong inhibitors or inducers of CYP2C9
- Use of strong inhibitors or inducers of CYP3A
- Difficulty tolerating oral medication (e.g., swallowing problems, malabsorption, nausea or vomiting)
- Women who are pregnant or breastfeeding
- Known allergy to study agents or their components
- Prior malignancies except certain treated cancers in remission
- Medical conditions increasing risk as judged by investigator
- Inability to comply with study procedures as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants receive the PCNA inhibitor AOH1996 orally twice daily on days 1-28. Treatment cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Visits occur during each 28-day treatment cycle as per protocol
Duration - Up to 30 days after last study drug is given
After completion of study treatment, participants are followed up to monitor safety and adverse events.
1 follow-up visit (in-person)
Trial Site Locations
Total: 2 locations
1
Honor Health Research and Innovation Institute
Scottsdale, Arizona, United States, 85258
Not Yet Recruiting
2
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
Research Team
V
Vincent Chung, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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