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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 89 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06907043
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Eikon Therapeutics
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Yawei Zhang, MD
Principal Investigator Affiliation Eikon Therapeutics
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Advanced Solid Tumors
Additional Details

This study will evaluate the safety, tolerability and preliminary efficacy of EIK1004 (IMP1707) as monotherapy in patients with recurrent, advanced/metastatic solid tumors. The study consists of 2 parts: Dose escalation and dose optimization. In dose escalation (Part1), the study will identify the maximum tolerated dose (MTD) or maximum achievable dose (MAD) in solid tumor. In dose optimization (Part 2), the study will further evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of select doses of EIK1004 (IMP1707)

Arms & Interventions

Arms

Experimental: Part 1

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.

Interventions

Drug: - EIK1004-001 (IMP1707-001)

PARP1 selective inhibitor

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Sunny Chaudry, MS

[email protected]

6319026200

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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