Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 1/Phase 2
Eikon Therapeutics (Voir sur ClinicalTrials)
décembre 2023
décembre 2027
16 juin 2026
This study investigates the safety and tolerability, pharmacokinetics (PK), and
pharmacodynamics (PD) of EIK1003 in participants with advanced solid tumors.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Alexandra LEARY | 26/06/2026 09:00:41 | Contacter | ||
Critères
Tous
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
- 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