EIK1004 for Cancer

(EIK1004-001 Trial)

Recruiting at 1 trial location

Overseen By Sunny Chaudry, MS

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Eikon Therapeutics

Must be taking: ADT

Must not be taking: PARP1 inhibitors

Disqualifiers: Infections, Bleeding, Gastrointestinal, others

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

Compensation: Varies

Number of Visits: Unknown

130 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will evaluate the safety, tolerability, and preliminary efficacy of EIK1004 (IMP1707) in participants with recurrent advanced/metastatic breast cancer, ovarian cancer, metastatic castrate resistant prostate cancer (mCRPC) and pancreatic cancer with deleterious/suspected deleterious mutations of select homologous recombination repair (HRR) genes. Condition or disease Intervention/treatment Phase Advanced Solid Tumors Drug: EIK1004 (IMP1707) Phase 1/Phase 2

Research Team

Yawei Zhang, MD

Principal Investigator

Eikon Therapeutics

Eligibility Criteria

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Part 1 Experimental Treatment 1 Intervention

EIK1004 (IMP1707) monotherapy; oral tablet(s) daily (except for the single-dose period). Participants will receive escalating doses of EIK1004 (IMP1707) until progressive disease or discontinuation.

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+