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AOH1996 for Refractory Solid Tumors

This study is testing a drug called AOH1996 for people with solid tumors that have not responded to previous treatments (refractory). This includes specific cancers like osteosarcoma, leiomyosarcomas, synovial sarcomas, and ovarian cancer. Researchers want to find the safest and most effective dose of AOH1996. They believe AOH1996 might work by stopping the growth of cancer cells. You can join if you are 18 or older, have a good performance status (meaning you can mostly care for yourself), and are willing to provide informed consent. The study is also looking at how well AOH1996 works and its side effects. The current status of this study is unclear, and it plans to enroll about 92 participants.

Study design
This is a dose-escalation study, meaning participants will receive increasing doses of AOH1996 to find the best dose. It plans to enroll about 92 participants.
What's involved
You would take AOH1996 by mouth twice a day for 28-day cycles. This continues as long as your disease doesn't get worse or you don't have severe side effects.
Compensation
Not stated in the trial record.
Follow-up
After you finish taking the study drug, you will be followed up for 30 days to check for any side effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05227326

AOH1996 for the Treatment of Refractory Solid Tumors

Recruiting
PHASE1Ages 18+InterventionalTreatment
City of Hope Medical Center
~92 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:PCNA Inhibitor AOH1996

At a glance

Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of adverse events (AEs)
Measured over Up to 30 days after last study drug is given
+1 more outcome measured

Conditions

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

Explore related trials

LeiomyosarcomaLung Non-Small Cell CarcinomaMalignant Ovarian NeoplasmOsteosarcomaPancreatic CarcinomaSolid NeoplasmSynovial Sarcoma

Where it's being run

3 sites across 2 states
California2
Arizona1

Study leadership

  • Vincent Chung, MD · PRINCIPAL_INVESTIGATOR · City of Hope Medical Center

Who to contact

Vincent Chung, MD
[email protected]
6262184673
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

1\. Documented informed consent by the participant
2\. Willingness to permit study team to obtain and use archival tissue, if already existing
3\. Age: ≥ 18 years
4\. ECOG performance status ≤ 2
5\. Life expectancy of \> 3 months
8\. ANC ≥ 1,500/mm3
9\. Platelets ≥ 100,000/mm3 :
10\. Total serum bilirubin ≤ 1.5 x ULN
11\. AST =\< 1.5 x ULN or =\< 3 x ULN with liver metastases
12\. ALT =\< 1.5 x ULN or =\< 3 x ULN with liver metastases
13\. Creatinine clearance of ≥ 60 mL/min per 24 hour urine or the Cockcroft-Gault
14\. Women of childbearing potential (WOCBP): negative urine or serum pregnancy test If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

Exclusion

2\. Other investigational products or chemotherapy. Exception: EGFR TKI in the NSCLC expansion cohort is allowed.
3\. Warfarin
4\. Current or planned use of agents contraindicated for use with strong CYP3A4 inducers
5\. Strong inhibitors or inducers of CYP2C9
6\. Strong inhibitors or inducers of CYP3A
7\. Issues with tolerating oral medication (e.g., inability to swallow pills, malabsorption issues, ongoing nausea or vomiting).
8\. Women who are or are planning to become pregnant or breastfeed
9\. Known allergy to any of the components within the study agents and/or their excipients.
10\. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.
11\. Intercurrent or historic medical condition that increases subject risk in the opinion of the Investigator. Eligibility may be revisited for intercurrent medical conditions once resolution/recovery is deemed adequate by the investigator (e.g. recovery from major surgery, completion of treatment for severe infection).

What this trial measures

  • Incidence of adverse events (AEs)Up to 30 days after last study drug is given

    Toxicity and adverse events will be recorded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. All toxicities/AEs will be recorded from the initiation of protocol therapy through the follow-up period.

  • Dose limiting toxicitiesUp to 28 days (cycle 1)

    Toxicities will be graded according to NCI CTCAE version 4.0.