Actively Recruiting
AOH1996 for the Treatment of Refractory Solid Tumors
Led by City of Hope Medical Center · Updated on 2025-09-18
92
Participants Needed
2
Research Sites
369 weeks
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
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.
CONDITIONS
Official Title
AOH1996 for the Treatment of Refractory Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided documented informed consent to participate
- Willing to allow study team to use existing archival tissue if available
- At least 18 years old
- ECOG performance status of 2 or less
- Life expectancy greater than 3 months
- Have a solid tumor that has failed standard therapies or are refusing standard treatments (except NSCLC patients stable on EGFR TKI for at least 2 months in combination cohort)
- Agree to use effective birth control or abstain from heterosexual activity during the study and for 30 days after last dose if of childbearing potential
- Absolute neutrophil count (ANC) of at least 1,500/mm3
- Platelet count of at least 100,000/mm3
- Total serum bilirubin no more than 1.5 times the upper limit of normal (ULN)
- AST and ALT no more than 1.5 times ULN (or up to 3 times ULN if liver metastases present)
- 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
- Current or planned use of drugs contraindicated with strong CYP3A4 inducers
- Use of strong inhibitors or inducers of CYP2C9 or CYP3A
- Difficulty tolerating oral medications, including inability to swallow pills or ongoing nausea/vomiting
- Women who are pregnant or planning to become pregnant or breastfeeding
- Known allergies to any study drug components or excipients
- Prior malignancies except for certain treated skin cancers, in situ cervical cancer, or stage I/II cancers in remission or any cancer disease free for 3 years
- Medical conditions increasing risk as judged by the investigator
- Potential inability to comply with all study procedures as judged by the investigator
AI-Screening
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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
CONTACT
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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