AOH1996 for the Treatment of Refractory Solid Tumors

NCT05227326 | Recruiting Phase 1 DMC FDA Drug

• 3 other identifiers: 21310NCI-2021-14102P30CA033572
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events (AEs)

  Toxicity and adverse events will be recorded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. All toxicities/AEs will be recorded from the initiation of protocol therapy through the follow-up period.

  Up to 30 days after last study drug is given

• Dose limiting toxicities

  Toxicities will be graded according to NCI CTCAE version 4.0.

  Up to 28 days (cycle 1)

Secondary Outcomes (4)

• Response rate

  Up to 2 years

• Progression-free survival

  Assessed up to 2 years

• Overall survival

  Assessed up to 2 years

• Time to treatment failure

  Assessed up to 2 years

Other Outcomes (1)

• Levels of plasma gammaH2AX

  Up to 2 years

Study Arms (1)

Treatment (PCNA inhibitor AOH1996)

EXPERIMENTAL

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.

Drug: PCNA Inhibitor AOH1996

Interventions

PCNA Inhibitor AOH1996 DRUG

Given PO

Also known as: AOH 1996, AOH-1996, AOH1996, Proliferating Cell Nuclear Antigen Inhibitor AOH1996

Treatment (PCNA inhibitor AOH1996)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent and Willingness to Participate
• \. Documented informed consent by the participant
• \. Willingness to permit study team to obtain and use archival tissue, if already existing
• Age Criteria, Performance Status and Life Expectancy
• \. Age: ≥ 18 years
• \. ECOG performance status ≤ 2
• \. 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)
• \. ANC ≥ 1,500/mm3
• \. Platelets ≥ 100,000/mm3 :
• \. Total serum bilirubin ≤ 1.5 x ULN

You may not qualify if:

• Concomitant Medications/Therapies \_\_1. Dietary/herbal supplements
• \. Other investigational products or chemotherapy. Exception: EGFR TKI in the NSCLC expansion cohort is allowed.
• \. Warfarin
• \. Current or planned use of agents contraindicated for use with strong CYP3A4 inducers
• \. Strong inhibitors or inducers of CYP2C9
• \. Strong inhibitors or inducers of CYP3A
• Other Illnesses and Conditions
• \. Issues with tolerating oral medication (e.g., inability to swallow pills, malabsorption issues, ongoing nausea or vomiting).
• \. Women who are or are planning to become pregnant or breastfeed
• \. Known allergy to any of the components within the study agents and/or their excipients.
• \. 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.
• \. 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.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Honor Health Research and Innovation Institute

Scottsdale, Arizona, 85258, United States

NOT YET RECRUITING

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Conditions

Osteosarcoma; Leiomyosarcoma; Sarcoma, Synovial; Ovarian Neoplasms; Carcinoma, Non-Small-Cell Lung; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma; Neoplasms, Muscle Tissue; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Pancreatic Diseases

Study Officials

• Vincent Chung, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vincent Chung, MD

CONTACT

626-359-8111; vchung@coh.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: February 7, 2022
• Study Start: August 12, 2022
• Primary Completion (Estimated): September 13, 2029
• Study Completion (Estimated): September 13, 2029
• Last Updated: September 18, 2025

Record last verified: 2025-09

Locations

US (2)