Using AOH1996 to treat hard-to-treat solid tumors
First in Human Phase 1 Study of AOH1996 in Patients With Refractory Solid Tumors
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 |
| Enrollment | 92 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | City of Hope Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Scottsdale, Arizona and 1 other locations) |
| Trial ID | NCT05227326 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with solid tumors that have failed standard treatments.
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.
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 performed: Other studies involving similar PCNA inhibitors have shown promise, but this specific approach is still in early phases and may be novel.
Eligibility criteria
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 this trial is running
Scottsdale, Arizona and 1 other locations
- Honor Health Research and Innovation Institute — Scottsdale, Arizona, United States (Not_yet_recruiting)
- City of Hope Medical Center — Duarte, California, United States (Recruiting)
Study contacts
- Principal investigator: Vincent Chung, MD — City of Hope Medical Center
- Study coordinator: Vincent Chung, MD
- Email: vchung@coh.org
- Phone: 626-359-8111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.