PCNA Inhibitor AOH1996 for Cancer

Overseen By Vincent Chung, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: City of Hope Medical Center

Must not be taking: Dietary supplements, Warfarin, CYP3A4 agents

Disqualifiers: Pregnancy, Breastfeeding, Allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days per cycle

54 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests AOH1996, a drug that may stop cancer cell growth by blocking essential enzymes. It targets patients with solid tumors that haven't responded to standard treatments.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, including dietary or herbal supplements, other investigational products, warfarin, and any agents that are strong inducers or inhibitors of specific liver enzymes (CYP3A4, CYP2C9, CYP3A).

What makes the drug AOH1996 unique for cancer treatment?

AOH1996 is unique because it targets a specific protein called PCNA, which is crucial for DNA replication and repair in cancer cells. This drug works by causing DNA damage selectively in cancer cells, while sparing healthy cells, and it can be taken orally without noticeable side effects. ^{1 2 3 4 5}

Research Team

Vincent Chung, MD

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

Inclusion Criteria

Documented informed consent by the participant

Willingness to permit study team to obtain and use archival tissue, if already existing

Eastern Cooperative Oncology Group (ECOG) performance status =< 2

Exclusion Criteria

Strong inhibitors or inducers of CYP2C9

You are taking warfarin (a blood thinner medication).

Current or planned use of agents contraindicated for use with strong CYP3A4 inducers

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive AOH1996 orally twice daily on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

28 days per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Long-term follow-up

Participants are monitored for progression-free survival and overall survival

Up to 2 years

Treatment Details

Interventions

• AOH1996

Participant Groups

Group I: Treatment (PCNA inhibitor AOH1996) Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Small molecule targeting of transcription-replication conflict for selective chemotherapy. [2023]

2. England pubmed.ncbi.nlm.nih.gov

ATX-101, a cell-penetrating protein targeting PCNA, can be safely administered as intravenous infusion in patients and shows clinical activity in a Phase 1 study. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Inhibition of gastric cancer cell proliferation by antisense oligonucleotides targeting the messenger RNA encoding proliferating cell nuclear antigen. [2019]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Targeting Proliferating Cell Nuclear Antigen (PCNA) as an Effective Strategy to Inhibit Tumor Cell Proliferation. [2020]

5. China pubmed.ncbi.nlm.nih.gov

[Construction of PCNA antisense RNA expression vector and its antitumorigenic effect on human gastric cancer cell]. [2006]