Testing AOH1996 in adults with hard-to-treat solid tumors
Tests the drug AOH1996 in adults whose solid tumors have not responded to treatment.
Plain-language title generated from the registry record
Registry title: AOH1996 for the Treatment of Refractory Solid Tumors
Key facts
- Where
- Duarte, Long Beach, and Scottsdale, United StatesSee the 3 sites
- Phase
- Phase 1
Where in United States
- City of Hope Medical CenterDuarte, United StatesTaking people
- City of Hope at Long Beach ElmLong Beach, United StatesTaking people
- Honor Health Research and Innovation InstituteScottsdale, United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- City of Hope Medical Center
- Trial code
- NCT05227326
- Record updated
- 20 October 2026
- Original description
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.Read full original descriptionShow less
First in Human Phase 1 Study of AOH1996 in Patients With Refractory Solid Tumors
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.
Inclusion: 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: Concomitant Medications/Therapies __1. Dietary/herbal supplements; 5. Strong inhibitors or inducers of CYP2C9; 7. Issues with tolerating oral medication (e.g., inability to swallow pills, malabsorption issues, ongoing nausea or vomiting); 6. Strong inhibitors or inducers of CYP3A; Other Illnesses and Conditions; 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; 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; 8. Women who are or are planning to become pregnant or breastfeed.