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RecruitingPhase 1 / Phase 2

A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707) in Participants With Advanced Solid Tumors.

A Phase 1/2, Open-label, Multicenter, Dose-escalation, and Dose-Optimization Study to Evaluate the Safety, Tolerability, and Activity of EIK1004 (IMP1707) as Monotherapy in Participants With Advanced Solid Tumors

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 89 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests EIK1004 (IMP1707) to learn about its safety, side effects, and how well it may work. It is for adults with certain cancers that have returned, are advanced, or have spread, and have harmful or likely harmful changes in certain genes that help repair DNA.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older, with breast, ovarian, fallopian tube, abdominal lining, prostate, or pancreatic cancer of the types listed in the study.
  • Prior treatment is required: chemotherapy for breast cancer, plus hormone treatment if the cancer uses hormones to grow; platinum chemotherapy for the listed ovarian-related cancers; or first treatment for pancreatic cancer.
  • For prostate cancer that has spread and no longer responds to lowering testosterone: continue hormone-lowering treatment, have had a newer hormone treatment, and have had no more than one course of taxane chemotherapy.
  • Have a harmful or likely harmful change in one of the selected HRR genes, which help repair DNA. Have had no more than one prior course of treatment containing a PARP inhibitor.
  • Be fully active or able to do light work, have organs that work well enough, and be expected to live at least 12 weeks.
  • Have cancer that can be checked with scans or the blood markers CA125 or PSA.
  • Brain or spinal cord spread may be allowed if previously treated, or if untreated and not needing immediate treatment in that area.
  • Men and women who can become pregnant must agree to use effective birth control during the study and for 6 months after the last dose.

Who can't join

  • Received any approved or experimental cancer treatment within 28 days before the first study dose, or previously received a drug that targets only PARP1.
  • Have a heart rhythm test measurement called QTcF above 470 or below 340 milliseconds.
  • Have an active hepatitis B or C infection, or a known tendency to bleed.
  • Cannot swallow pills, or have a condition that keeps the body from absorbing medicine properly.
  • Have an untreated brain tumor spot larger than 2 centimeters, or any brain spot needing immediate treatment.
  • Use steroids that act throughout the body to control symptoms of brain or spinal cord spread within 7 days before treatment, or need more than 10 mg of prednisone a day.
  • Have known cancer spread to the lining around the brain or spinal cord that causes symptoms.
  • Have seizures that are not well controlled.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

• Breast cancer: must have received at least one prior chemotherapy in neoadjuvant/adjuvant/metastatic setting, must have received hormonal therapy if HR+, HGSOC or high grade endometrioid EOC, fallopian tube or primary peritoneal cancer; must have received at least one prior platinum-based chemotherapy for advanced disease. mCRPC with ongoing ADT, must have received NHA and up to 1 prior line of taxane chemotherapy; Pancreatic cancer, must have prior 1L therapy * Age ≥ 18 years at the time of informed consent * Eastern Cooperative Oncology Group (ECOG) performance status ≤1 * Adequate organ function * Life expectancy ≥ 12 weeks * Should have evaluable disease as defined by RECIST1.1 and/or CA125 or PSA * Female subjects of childbearing potential and male subjects must agree to use an effective method of contraception from study entry up to 6 months after the last dose of EIK1004 (IMP1707) * Deleterious or suspected deleterious germline or somatic mutations of select HRR genes * Up to 1 prior line of PARP inhibitor containing treatment CNS Inclusion Criteria: * Untreated CNS metastases (measurable and/or non-measurable) not needing immediate local therapy. * Previously treated CNS metastases Key Exclusion Criteria: * Any investigational or approved anti-cancer therapies administered within 28 days/ before the first dose of EIK1004 (IMP1707) * Have received prior PARP1 selective inhibitors * Mean resting QTcF \> 470 ms or QTcF \< 340 ms * Infections \- An active hepatitis B/C infection * Any known predisposition to bleeding * Unable to swallow oral medications OR have malabsorption syndrome or any other uncontrolled gastrointestinal condition that might impair the bioavailability CNS Exclusion Criteria * Any untreated brain lesions \> 2.0 cm in size. * Ongoing use of systemic corticosteroids for control of symptoms of CNS metastases \< 7 days prior to the first dose of study treatment or requirement for \> 10 mg prednisone/day. * Any brain lesion requiring immediate local therapy, including (but not limited to) a lesion in an anatomic site where an increase in size or possible treatment-related edema may pose risk to the participant (eg, brain stem lesions). * Known, symptomatic leptomeningeal disease. * Have poorly controlled seizures.

Study sites (6)

CO

FL

MA

TX

VA