PCNA Inhibitor AOH1996 for Cancer

VC
Overseen ByVincent Chung, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment, AOH1996, to determine if it can stop the growth of solid tumors unresponsive to other treatments. The goal is to identify the best dose and understand any side effects. AOH1996 blocks enzymes that tumor cells need for growth. This trial may suit adults with solid tumors who have tried standard treatments without success or opted not to undergo them. Participants must be able to take oral medication and meet certain health criteria. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

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).

Is there any evidence suggesting that AOH1996 is likely to be safe for humans?

Research shows that AOH1996 targets and kills cancer cells without affecting normal cells. This selectivity could make it safer for patients. In studies with mice, AOH1996 significantly reduced tumor size, which is promising. However, these results are early and mostly from lab studies, not from humans.

As a Phase 1 trial, this is the first time AOH1996 is tested in humans. Phase 1 trials focus on understanding the treatment's safety and finding the best dosage. While there is hope it will be well-tolerated, the full safety details in humans remain unknown. Participants in the trial will help researchers learn more about AOH1996's safety for people.12345

Why do researchers think this study treatment might be promising?

The PCNA inhibitor AOH1996 is unique because it targets the proliferating cell nuclear antigen (PCNA), a protein crucial for cancer cell growth and survival. Unlike conventional treatments that might focus on killing cancer cells through chemotherapy or radiation, AOH1996 specifically disrupts the replication process of cancer cells at a fundamental level, potentially offering a more targeted approach. Researchers are excited about AOH1996 because its novel mechanism could lead to fewer side effects and offer an effective option for patients who have not responded well to existing therapies.

What evidence suggests that AOH1996 might be an effective treatment for cancer?

Research has shown that AOH1996, the investigational treatment in this trial, could be a promising cancer therapy. Studies have found that AOH1996 blocks proteins essential for cancer cell growth. In lab tests, AOH1996 killed cancer cells while sparing healthy cells, even at high doses. It has proven effective against various cancers, including breast, prostate, brain, and lung cancer. The treatment halts cancer growth by targeting cancer stem cells, which play a key role in cancer spread and resistance. This suggests AOH1996 could offer a promising new approach to treating difficult tumors.34567

Who Is on the Research Team?

VC

Vincent Chung, MD

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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
See 11 more

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
See 10 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • AOH1996
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (PCNA inhibitor AOH1996)Experimental Treatment1 Intervention

Find a Clinic Near You

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+

Citations

From “undruggable” target to clinical potentialEarly clinical data suggest AOH1996's most significant potential lies in combination therapy. Collaborations with institutions, including ...
The PCNA inhibitor AOH1996 suppresses cancer stemness ...Taken together, our results demonstrated that AOH1996 suppressed tumor growth, eliminated cancer stem cells (CSCs), and synergistically enhanced ...
Enhanced lung cancer treatment using AOH1996, a potent ...These effects are cancer specific and AOH1996 has little effect on non-cancerous cells even at 6-fold the effective dose in cancer cells.
Small molecule targeting of transcription-replication conflict for ...AOH1996 selectively kills cancer cells. The median concentration to achieve 50% growth inhibition (GI 50) was approximately 300 nM across more than 70 cancer ...
City of Hope scientists develop targeted chemotherapy ...AOH1996 has been effective in preclinical research treating cells derived from breast, prostate, brain, ovarian, cervical, skin and lung ...
AOH1996 | CAS#2089314-64-5 | PCNA inhibitorAOH1996 is a potent PCNA inhibitor. AOH1996, which selectively kills cancer ... Safety Data Sheet (SDS). View Safety Data Sheet (SDS). Instruction. View ...
AOH1996 | PCNA inhibitorAOH1996 alone or in combination with topoisomerase inhibitor CPT-11 significantly reduced tumor burden in mice with xenograft tumors (neuroblastoma, breast, or ...
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