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

More details:

Overview

EIK1004 (formerly IMP1707) is an investigational cancer drug; EIK1004-001 is its ongoing phase 1/2 trial, not another name for the drug. The trial is testing EIK1004 alone in people with advanced ovarian, breast, prostate, or pancreatic cancer and selected DNA-repair gene mutations, including some people with brain metastases. (aacrjournals.org)

Mechanism of action

EIK1004 is designed to inhibit PARP1, a DNA-repair enzyme, while largely sparing PARP2. In laboratory tests it also trapped PARP1 on DNA; in mouse models it reached the brain and caused regression of tumors implanted there. These are preclinical findings, not evidence of benefit in people. (aacrjournals.org)

Efficacy

Limited human results have been disclosed, but no reliable response rate is available. In a company filing reporting data through October 27, 2025, 16 patients had received doses of 10–40 mg, and one unconfirmed partial response was reported at 10 mg. The filing did not establish how many patients were evaluable for response. The company planned to present its first fuller clinical dataset in October 2026. (sec.gov)

Safety

The same filing reported no dose-limiting toxicities among the 16 enrolled patients as of October 27, 2025. That small, early dataset cannot establish the drug’s overall safety profile. (sec.gov)

Further reading

• AACR 2025 preclinical abstract (aacrjournals.org)
• AACR 2026 clinical-trial design abstract (aacrjournals.org)
• Company filing containing the preliminary human observations (sec.gov)

Last updated: Sep 2026

• 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.