AOH1996 for the Treatment of Refractory Solid Tumors

Launched by CITY OF HOPE MEDICAL CENTER · Feb 3, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called AOH1996 for patients with certain types of solid tumors that have not responded to standard treatments. Solid tumors include cancers like osteosarcoma, ovarian cancer, and non-small cell lung cancer, among others. The goal of the trial is to find the best dose of AOH1996 and understand its side effects. AOH1996 works by blocking certain enzymes that cancer cells need to grow, which may help slow down or stop the growth of the tumors.

To be eligible for this trial, participants must be at least 18 years old and have solid tumors that have not improved with standard therapies. They should have a life expectancy of more than three months and be willing to allow researchers to use existing tissue samples for testing. Participants should also be able to take oral medications, as AOH1996 is given in pill form. Throughout the trial, participants will be monitored for any side effects, and they will need to use birth control if they are capable of becoming pregnant. This study is currently recruiting participants, so those interested should discuss it with their healthcare provider.

Gender

ALL

Eligibility 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.