Trial NCT06907043
A Study of PARP1 Selective Inhibitor, EIK1004 (IMP1707) in Participants With Advanced Solid Tumors.
- Phase
- Phase 1/2
- Sponsor
- Eikon Therapeutics
- Conditions
- Advanced Solid Tumors
- Ages
- 18–89 years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
• 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 msCardiac
* 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.Brain metastases
* Have poorly controlled seizures.
Restrictions found (2)
- Brain metastasesOutrightexclusionShow in the text
- CardiacOutrightexclusion
QTcF > 470 ms or QTcF < 340 ms
Show in the text
Recruiting in Massachusetts
- Beth Israel Deaconess Medical Center · Boston, Suffolk County