Using AOH1996 to treat hard-to-treat solid tumors
Official title: First in Human Phase 1 Study of AOH1996 in Patients With Refractory Solid Tumors
Run by City of Hope Medical Center · NCT05227326 · Data updated 2026-11-12
This study is testing a new drug called AOH1996 to see if it is safe and effective for people with hard-to-treat solid tumors like certain sarcomas and ovarian cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 92 (estimated) |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Scottsdale, Arizona and 2 other locations) |
| Status | Recruiting |
| Started | September 8, 2022 |
| Main results expected | September 13, 2029 |
| Study ends | September 13, 2029 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT05227326 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with solid tumors that have failed standard treatments.
✕Probably not a fit
Patients with tumors that are responding to standard therapies or those with a life expectancy of less than three months may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase I trial investigates the safety and optimal dosage of AOH1996 in patients with refractory solid tumors, including various types of sarcomas and ovarian cancer. The study aims to determine the maximum tolerated dose and any dose-limiting toxicities associated with AOH1996, while also evaluating its pharmacokinetics and preliminary efficacy. Patients will take AOH1996 orally twice daily for 28-day cycles, with follow-up assessments conducted after treatment completion.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for patients with solid tumors that have not responded to existing therapies.
How similar studies have gone: Other studies involving similar PCNA inhibitors have shown promise, but this specific approach is still in early phases and may be novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Informed Consent and Willingness to Participate * 1\. Documented informed consent by the participant * 2\. Willingness to permit study team to obtain and use archival tissue, if already existing Age Criteria, Performance Status and Life Expectancy * 3\. Age: ≥ 18 years * 4\. ECOG performance status ≤ 2 * 5\. Life expectancy of \> 3 months Nature of Illness and Treatment History \_\_6. Patients with solid tumors failing standard therapies or patients refusing standard treatments (exception: Part B NSCLC combination (EGFR TKI + AOH1996) cohort: patients with stable disease or better on EGFR TKI for at least 2 months) Contraception \_\_7. Agreement by females and males of childbearing potential\* to use an adequate method of birth control (hormonal contraception is inadequate) or abstain from heterosexual activity for the course of the study through 30 days after the last dose of study medication. See Appendix B for guidelines. \- Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only). Laboratory Criteria (to be performed within 14 days prior to Day 1) * 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 Criteria Concomitant Medications/Therapies \_\_1. Dietary/herbal supplements * 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 Other Illnesses and Conditions * 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). Noncompliance \_\_12. Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics). \*\*Eligibility should be confirmed per institutional policies.
Where it's running
-
City of Hope Medical Center
Duarte, California, United States Recruiting -
City of Hope at Long Beach Elm
Long Beach, California, United States Recruiting -
Honor Health Research and Innovation Institute
Scottsdale, Arizona, United States Not yet recruiting
Study contacts
- Principal investigator: Vincent Chung, MD — City of Hope Medical Center
- Study coordinator: Vincent Chung, MD
- Email: vchung@coh.org
- Phone: 6262184673
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
CAIX-targeted 18F-T2 PET/CT imaging in solid tumors
This study tests a CAIX-specific radioactive tracer to see if PET/CT can help visualize solid tumors and checks safety and radiation exposure in adults with certain cancers.
-
Evaluating zanidatamab for HER2-expressing tumors
This study is testing a new drug called zanidatamab to see if it can help people with certain types of cancer that have high levels of HER2 and who have already tried other treatments without success.
-
LY4052031 for advanced or metastatic urothelial and other nectin‑4–expressing solid tumors
This trial will test whether LY4052031 is safe and can help people with advanced or metastatic urothelial cancer or other solid tumors that express nectin‑4.
-
Testing MDX2001 for advanced solid tumors
This study is testing a new drug called MDX2001 to see if it can safely help people with advanced solid tumors like breast or colon cancer.
-
Analyzing solid tumors for HLA loss and collecting T cells for CAR T-cell therapy
This study is testing how often solid tumors lose a key protein that helps the immune system recognize them, while also collecting T cells from patients with high-risk cancers to prepare for future CAR T-cell therapy.
-
ABBV-253 in adults with advanced solid tumors
This study tests ABBV-253 to see if it is safe, how it affects the cancer, and how the drug moves in the body for adults with advanced solid tumors.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.