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 Recruiting
Countries Australia, China, United States
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 a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Denver 5419384, Colorado 5417618

Status

Recruiting

Address

Sarah Cannon Research Institute at HealthOne

Denver 5419384, Colorado 5417618, 80218

Site Contact

Shelby Mosier-Murray

[email protected]

720-701-0123

Florida Cancer Center, Lake Mary 4161373, Florida 4155751

Status

Recruiting

Address

Florida Cancer Center

Lake Mary 4161373, Florida 4155751, 32746

Site Contact

Alexander Philipovskiy

[email protected]

407-804-6133

Beth Israel Deaconess Medical Center, Boston 4930956, Massachusetts 6254926

Status

Recruiting

Address

Beth Israel Deaconess Medical Center

Boston 4930956, Massachusetts 6254926, 02215

Site Contact

Gary Barahona

[email protected]

617-975-7474

MD Anderson, Houston 4699066, Texas 4736286

Status

Recruiting

Address

MD Anderson

Houston 4699066, Texas 4736286, 77030

Site Contact

Cindy Bang

[email protected]

877-632-6789

NEXT Oncology, San Antonio 4726206, Texas 4736286

Status

Recruiting

Address

NEXT Oncology

San Antonio 4726206, Texas 4736286, 78229

Site Contact

China Whitwer

[email protected]

210-580-9500

NEXT Virginia, Fairfax 4758023, Virginia 6254928

Status

Recruiting

Address

NEXT Virginia

Fairfax 4758023, Virginia 6254928, 22031

Site Contact

Nicole Bryson

[email protected]

703-783-4510

International Sites

PASO Medical, Frankston 2166144, Victoria 2145234, Australia

Status

Recruiting

Address

PASO Medical

Frankston 2166144, Victoria 2145234, 3199

Site Contact

Vinod Ganju

[email protected]

397815244

Chongqing University Cancer Hospital, Chongqing 1814906, Chongqing Municipality 1814905, China

Status

Recruiting

Address

Chongqing University Cancer Hospital

Chongqing 1814906, Chongqing Municipality 1814905, 400030

Site Contact

Yongsheng Li-PI

[email protected]

023-65311341

Jinan 1805753, Shandong 1796328, China

Status

Recruiting

Address

Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital)

Jinan 1805753, Shandong 1796328, 250117

Site Contact

Yuping Sun

[email protected]

0531-67626073

Fudan University Shanghai Cancer Center, Shanghai 1796236, China

Status

Recruiting

Address

Fudan University Shanghai Cancer Center

Shanghai 1796236, ,

Site Contact

Yunyan Guo

[email protected]

6319026200

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