AOH1996 for the Treatment of Refractory Solid Tumors

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.

Conditions

Refractory Malignant Solid Neoplasm, Osteosarcoma, Leiomyosarcomas, Synovial Sarcomas, Ovarian Cancer, Non-Small Cell Lung Cancer, Pancreatic Cancer

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Study Overview

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Study Details

Study overview

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.

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

AOH1996 for the Treatment of Refractory Solid Tumors

Condition
Refractory Malignant Solid Neoplasm
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Honor Health Research and Innovation Institute, Scottsdale, Arizona, United States, 85258

Duarte

City of Hope Medical Center, Duarte, California, United States, 91010

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 1. Documented informed consent by the participant
  • * 2. Willingness to permit study team to obtain and use archival tissue, if already existing
  • * 3. Age: ≥ 18 years
  • * 4. ECOG performance status ≤ 2
  • * 5. Life expectancy of \> 3 months
  • * 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
  • * 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
  • * 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).

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

City of Hope Medical Center,

Vincent Chung, MD, PRINCIPAL_INVESTIGATOR, City of Hope Medical Center

Study Record Dates

2026-01-29