AOH1996 for the Treatment of Refractory Solid Tumors

Q: What is the NCT05227326 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Q: Who can participate in NCT05227326?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

Q: How do I contact the trial site for NCT05227326?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Q: Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Q: Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

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

AOH1996 for the Treatment of Refractory Solid Tumors (NCT05227326) is a Phase 1 interventional studying Refractory Malignant Solid Neoplasm and Osteosarcoma, sponsored by City of Hope Medical Center. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Refractory Malignant Solid Neoplasm, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 92 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Refractory Malignant Solid Neoplasm subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: willing to sign a consent form and Willingness to Participate - 1\. Documented willing to sign a consent form 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\. white blood cell count (ANC) at least 1,500/mm3 - 9\. platelet count at least 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

PCNA Inhibitor AOH1996

Given PO

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Honor Health Research and Innovation Institute

Scottsdale, Arizona, United States

City of Hope Medical Center

Duarte, California, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05227326), the sponsor (City of Hope Medical Center), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05227326 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05227326?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05227326?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05227326. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05227326. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.