OMO-103 for Pancreatic Cancer

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: OHSU Knight Cancer Institute

Must not be taking: Chemotherapy, Immunotherapy, Hormonal, others

Disqualifiers: Congestive heart failure, Angina, others

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

Compensation: Varies

Number of Visits: 32

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how a new treatment, OMO-103, affects pancreatic cancer that has spread locally or to other parts of the body. OMO-103 aims to block certain enzymes to stop tumor cells from growing. Researchers seek to understand how this drug changes pancreatic tumor cells. Individuals with a confirmed diagnosis of advanced or spreading pancreatic cancer, who can handle treatment-related biopsies, might be suitable for this trial. As an Early Phase 1 trial, this research focuses on understanding how OMO-103 works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial requires a 14-day period without any prior cancer treatments before starting the study medication. However, the protocol does not specify if you need to stop other non-cancer medications, so it's best to discuss this with the trial team.

Is there any evidence suggesting that OMO-103 is likely to be safe for humans?

Research has shown that OMO-103 has been tested for safety in patients with advanced solid tumors. In these studies, OMO-103 proved generally safe and well-tolerated, with few serious side effects reported. Most patients experienced mild to moderate effects, which are common in cancer treatments.

The studies primarily focused on understanding how the body processes OMO-103 and its initial safety. Researchers checked for any negative reactions or issues that might occur. So far, results have been promising in terms of safety, but it's important to remember that this is an early-stage trial. More research is needed to fully understand all potential risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Most treatments for pancreatic cancer, like chemotherapy and targeted therapy, aim to stop cancer cells from growing and dividing. But OMO-103 works differently, targeting a specific protein involved in cancer cell survival and resistance. Researchers are excited about OMO-103 because it uses a novel mechanism that could potentially overcome resistance to existing treatments, offering new hope for patients who have limited options. Additionally, this treatment is administered intravenously, allowing for precise dosing and monitoring, which could enhance its effectiveness and safety profile.

What evidence suggests that OMO-103 might be an effective treatment for pancreatic cancer?

Research shows that OMO-103 blocks certain proteins that aid cancer cell growth. In previous studies, OMO-103 showed promising results in patients with various advanced solid tumors. The treatment successfully reached the tumor and proved safe for patients. Early findings suggest that OMO-103 can effectively target and affect tumor cells. These results offer hope that OMO-103 may benefit people with pancreatic cancer, especially in difficult-to-treat cases. Participants in this trial will receive OMO-103 to further evaluate its effectiveness and safety in treating pancreatic cancer. ^{2 5 6 7 8}

Who Is on the Research Team?

Charles D Lopez

Principal Investigator

OHSU Knight Cancer Institute

Are You a Good Fit for This Trial?

This trial is for individuals with pancreatic ductal adenocarcinoma that's either locally advanced or metastatic. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may need to have measurable disease.

Inclusion Criteria

Must provide written informed consent before any study-specific procedures or interventions are performed

My condition is advanced pancreatic cancer.

Hemoglobin ≥ 7.5 g/dL

Exclusion Criteria

I am not currently using any other cancer treatments not allowed in this study.

Known severe hypersensitivity to OMO-103 or to any excipient of these medicinal products, or history of allergic reactions attributed to compounds of similar chemical or biologic composition

History of psychiatric illness likely to interfere with ability to comply with protocol requirements or give informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive OMO-103 intravenously on days 1 and 8, with additional procedures including CT or MRI, tumor biopsies, and blood sample collection

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Follow-up at 30 days and then periodically for 1 year

What Are the Treatments Tested in This Trial?

Interventions

• OMO-103

Trial Overview The trial is evaluating the biological activity of a new potential cancer drug called OMO-103. It includes collecting biospecimens, performing biopsies, and imaging tests like CT scans and MRIs to see how the tumor cells respond to the treatment.

How Is the Trial Designed?

Group I: Treatment (OMO-103) Experimental Treatment 5 Interventions

Patients receive OMO-103 IV over 30-45 minutes on days 1 and 8 in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI, tumor biopsies, and collection of blood samples throughout the study.

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials

239

Recruited

2,089,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07089940

Study Details | NCT07089940 | OMO-103 for the Treatment ... OMO-103 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This trial may help researchers determine how exposure to OMO ...

2. nature.com nature.com/articles/s41591-024-02805-1

MYC targeting by OMO-103 in solid tumors: a phase 1 trial Here we present results from a phase 1 study of OMO-103 in advanced solid tumors, established to examine safety and tolerability as primary outcomes and ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12069295/

Rethinking MYC inhibition: a multi-dimensional approach to ... In this clinical trial, OMO-103 demonstrated not only a robust safety profile but also encouraging pharmacokinetics, effectively achieving tumor ...

4. peptomyc.com peptomyc.com/peptomyc-announces-research-ind-approval-for-innovative-window-of-opportunity-trial-in-collaboration-with-ohsu-knight-cancer-institute-portland-oregon-usa-in-pdac-patients/

Peptomyc announces Research IND Approval for ... The 5-year relative survival rate is only about 11% for all stages and 3% for metastatic disease. PDAC is characterized by late detection and ...

5. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e15168

Pharmacokinetic analysis of OMO-103 in patient tissues ... Here, we present PK results from the first-in-human trial (NCT04808362) of OMO-103 in patients with advanced solid tumors.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06059001

NCT06059001 | Study to Evaluate the Safety, PK, and ... To evaluate the safety and tolerability of OMO-103 plus gemcitabine/nab-paclitaxel in adult patients with metastatic pancreatic cancer being treatment naïve.

7. esmo.org esmo.org/oncology-news/safety-and-preliminary-signs-of-activity-of-omo-103-a-myc-inhibitor-in-allcomers-solid-tumours

Safety and Preliminary Signs of Activity of OMO-103, ... In a first-in-human phase I dose-escalation study of OMO-103, a MYC inhibitor, conducted in patients with solid tumours, treatment was safe and showed ...

8. vhio.net vhio.net/2024/02/06/first-myc-inhibitor-to-demonstrate-safety-and-anti-tumor-activity-in-a-phase-i-first-in-human-clinical-trial/

First MYC inhibitor to demonstrate safety and anti-tumor ... This study was designed to assess the safety, pharmacokinetics, and preliminary signs of clinical activity of OMO-103 in patients with advanced solid tumors.