RECRUITING

AOH1996 for the Treatment of Refractory Solid Tumors

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-08-12

Study Completion:2026-01-29

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05227326

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion 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).

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Vincent Chung, MD

CONTACT

626-359-8111

vchung@coh.org

Principal Investigator

Vincent Chung, MD

PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Study Locations (Sites)

Honor Health Research and Innovation Institute

Scottsdale, Arizona, 85258

United States

City of Hope Medical Center

Duarte, California, 91010

United States

Collaborators and Investigators

Sponsor: City of Hope Medical Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-12

Study Completion Date2026-01-29

Study Record Updates

Study Start Date2022-08-12

Study Completion Date2026-01-29

Terms related to this study

Additional Relevant MeSH Terms

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