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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
United States
Arizona
Honor Health Research and Innovation Institute
NOT_YET_RECRUITING
Scottsdale
California
City of Hope Medical Center
RECRUITING
Duarte
Contact Information
Primary
Vincent Chung, MD
vchung@coh.org
626-359-8111
Time Frame
Start Date: 2022-08-12
Estimated Completion Date: 2029-09-13
Participants
Target number of participants: 92
Treatments
Experimental: Treatment (PCNA inhibitor AOH1996)
Patients receive PCNA inhibitor AOH1996 PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Sponsors
Leads: City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov