130 Participants Needed

EIK1004 for Cancer

(EIK1004-001 Trial)

Recruiting at 9 trial locations
SC
Overseen BySunny Chaudry, MS
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Eikon Therapeutics
Must be taking: ADT
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 tests a new drug, EIK1004 (also known as IMP1707), to determine its safety and effectiveness for individuals with certain advanced cancers, including breast, ovarian, prostate, and pancreatic cancer. Researchers aim to assess the drug's efficacy and patient tolerance. Individuals who have battled these cancers, particularly those with specific genetic mutations affecting DNA repair and who have undergone previous treatments, might be suitable candidates. Participants will take the drug in tablet form daily, with certain exceptions. As a Phase 1 trial, the research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial requires that you stop any investigational or approved anti-cancer therapies at least 28 days before starting the study drug. If you're on other medications, the protocol doesn't specify, so it's best to discuss with the trial team.

Is there any evidence suggesting that EIK1004 (IMP1707) is likely to be safe for humans?

Research has shown that EIK1004 (also called IMP1707) is being tested for safety and tolerability in people with advanced solid tumors. Early studies suggest that patients generally tolerate the treatment well, with manageable side effects. However, since EIK1004 remains in early testing stages, unknown risks may exist. Researchers closely monitor trial participants to identify any unwanted effects. This ongoing research aims to ensure the treatment's safety for future use.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about EIK1004 (IMP1707) because it offers a new approach to cancer treatment by acting as a monotherapy with a unique mechanism of action. Unlike traditional cancer treatments, which often involve chemotherapy or targeted therapies against specific proteins, EIK1004 is designed to be taken orally and works by escalating doses until the disease progresses or the patient discontinues use. This oral administration and dose escalation could potentially offer more flexibility and a tailored approach to individual patients, setting it apart from current options. The potential for improved convenience and customization in treatment is what makes this drug particularly promising in the fight against cancer.

What evidence suggests that EIK1004 (IMP1707) might be an effective treatment for advanced solid tumors?

Research has shown that EIK1004 (also known as IMP1707), the investigational treatment in this trial, could be promising for certain cancers. It blocks a protein called PARP1, which aids cancer cells in repairing themselves. Studies have found that targeting PARP1 can be particularly effective in cancers with specific gene changes, such as those in breast and ovarian cancers. This treatment is designed to reach the brain, which is crucial for treating cancers that spread there. Early results suggest EIK1004 possesses strong drug properties, making it a good candidate for further research. Although additional studies are necessary, the mechanism of EIK1004 offers hope for treating advanced solid tumors.12678

Who Is on the Research Team?

YZ

Yawei Zhang, MD

Principal Investigator

Eikon Therapeutics

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced breast, ovarian, prostate or pancreatic cancer and certain gene mutations. They should be relatively healthy (ECOG ≤1), have a life expectancy of at least 12 weeks, and agree to use contraception. It's not for those who've had more than one prior PARP inhibitor treatment or don't meet specific previous therapy requirements.

Inclusion Criteria

My doctor expects me to live for at least 12 more weeks.
I've had chemotherapy for breast cancer and, if HR+, hormonal therapy.
I have mCRPC with ADT and had NHA and possibly one chemotherapy; or I have pancreatic cancer with one prior therapy.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of EIK1004 (IMP1707) to identify the maximum tolerated dose (MTD) or maximum achievable dose (MAD)

Up to 28 days

Dose Optimization

Further evaluation of safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of select doses of EIK1004 (IMP1707)

Through study completion, up to 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 month post last dose

What Are the Treatments Tested in This Trial?

Interventions

  • EIK1004 (IMP1707)
Trial Overview The study tests EIK1004 (IMP1707), focusing on its safety and early effectiveness in patients with specific cancers that have genetic changes affecting DNA repair. Participants will receive this drug to see how well it works against their tumors.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Part 1Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eikon Therapeutics

Lead Sponsor

Trials
8
Recruited
1,300+

Impact Therapeutics, Inc.

Industry Sponsor

Trials
15
Recruited
1,600+

Citations

A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707 ...This study will evaluate the safety, tolerability, and preliminary efficacy of EIK1004 (IMP1707) in participants with recurrent advanced/metastatic breast ...
Abstract 5719: Identification of EIK1004 (IMP1707), a CNS ...EIK1004 (previously IMP1707) is a potent, CNS-penetrant, PARP1-selective molecule with robust pharmaceutical properties.
A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707) in ...This study will evaluate the safety, tolerability, and preliminary efficacy of EIK1004 ... Phase 2: Studies that gather preliminary data on effectiveness (whether ...
A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707) ...This study will evaluate the safety, tolerability, and preliminary efficacy of EIK1004 (IMP1707) in participants with recurrent advanced ...
A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707) ...This study will evaluate the safety, tolerability, and preliminary efficacy of EIK1004 (IMP1707) in participants with recurrent advanced/metastatic breast ...
A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707) ...This study will evaluate the safety, tolerability, and preliminary efficacy of EIK1004 (IMP1707) in participants with recurrent advanced/ ...
Eikon Therapeutics to Share Clinical Data and Program ...“The steady progress we are making as evidenced by the first safety and efficacy data from EIK1003, the initiation of our adaptive melanoma ...
A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707 ...This study will evaluate the safety, tolerability, and preliminary efficacy of EIK1004 (IMP1707) in participants with recurrent advanced/metastatic breast ...
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