Clinical trial · Interventional
A First-in-human Study of PARP1 Selective Inhibitor, IMP1734, in Participants With Advanced Solid Tumors
A First-in-human, Phase 1/2, Open-label, Multi-center, Dose-escalation, Dose-optimization, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of PARP1 Selective Inhibitor, IMP1734, as Monotherapy in Patients With Advanced Solid Tumors
NCT06253130CI-TRIAL-00114748recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study investigates the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of EIK1003 in participants with advanced solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMP1734 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- IMP1734 monotherapy; oral tablet(s) daily (except for the single-dose period). The maximum trial duration is 3 years after the last participant's first treatment in the trial.
- interventionNames
- Drug: IMP1734
Primary outcomes (2)
- measure
- Number of subjects with adverse events, treatment emergent adverse events or serious adverse events
- timeFrame
- Consent to 30 + 7 days post last dose of IMP1734
- description
- Number of subjects reporting adverse events or serious adverse events which include any abnormal clinical events, laboratory assessments outside of normal clinical range, abnormal vital signs observed, and any abnormal ECG parameters
- measure
- Maxim Tolerated Dose or Recommended Dose for Expansion
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Key Inclusion 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 * 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 IMP1734 * deleterious or suspected deleterious germline or somatic mutations of select HRR genes * up to 1 prior line of PARP inhibitor containing treatment Key Exclusion Criteria: * Any investigational or approved anti-cancer therapies administered within 28 days/ before the first dose of IMP1734 * Have received prior PARP1 selective inhibitors * Mean resting QTcF \> 470 ms or QTcF \< 340 ms * Active or untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. * 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
References
Publications (0)
Data not yet available
No reference posted for this study.