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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 and in combination in participants with advanced solid tumors.

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509230-19-00
Acronym
EIK1003-001
Enrollment
82
Registered
2024-07-24
Start date
2024-11-14
Completion date
Unknown
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advance solid tumors

Brief summary

Part 1 and 2: • TEAEs • DLTs • Laboratory parameters • Vital signs • ECGs • MTD (or MAD) and RDE of IMP1734 as monotherapy and in combination with anti-cancer agents, Part 3: • Overall response rate, which is defined as the percentage of participants who have CR/PR per RECIST v1.1 by Investigator, and/or CA125 response per GCIG criteria (ovarian cancer), and/or PSA response per PCWG3 criteria.

Detailed description

PK parameters derived from plasma concentration data of IMP1734 and/or metabolites (if applicable) following single oral dose: • Cmax, Tmax, AUC0-t, AUC0-tau, Cmax(dn), and AUC0-tau(dn) • If data permit, AUC0-inf, CL/F, Vd/F, and t1/2, PK parameters derived from plasma concentration data of IMP1734 and/ormetabolites (if applicable) following multiple oral doses: • Cmax,ss, Ctrough, Tmax,ss, AUC0-t,ss, AUC0-tau,ss, Cmax,ss(dn), AUC0-tau(dn), Rac-Cmax,ss and Rac-AUC0-tau,ss, • If data permit, CL/F, Vd/F, and t1/2 • Overall response rate, which is defined as the percentage of participants who have CR/PR per RECIST v1.1, by Investigator and/or CA125 response per GCIG criteria (ovarian cancer), and/or PSA response per PCWG3 criteria., • Efficacy evaluated per RECIST v1.1 by Investigator: o ORR, which is defined as the percentage of participants who have CR/PR o DCR o DOR o TTR o Percentage change in sum of target lesions o CBR, which is defined as the proportion of participants with BOR of CR, PR or lasting ≥ 18 weeks of SD after the start of the study drug, • PFS • OS • For prostate cancer only: o PSA response per PCWG3 criteria o PSA progression o PSA complete response rate, Part 3: • Efficacy evaluated per RECIST v1.1 by Investigator: o ORR, which is defined as the percentage of patients who have CR/PR o DCR o DOR o TTR o Percentage change in sum of target lesions o CBR, which is defined as the proportion of participants with BOR of CR, PR or lasting ≥ 18 weeks of SD after the start of the study drug, Part 3:• PFS • OS • For prostate cancer only: o PSA response per PCWG3 criteria o Time to PSA progression, • TEAEs • Laboratory parameters • Vital signs • ECGs

Interventions

DRUGPREDNISONE
DRUGABIRATERONE
DRUGEIK1003 5mg Tablets
DRUGPACLITAXEL
DRUGEIK1003 20mg Tablets

Sponsors

Eikon Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Part 1 and 2: • TEAEs • DLTs • Laboratory parameters • Vital signs • ECGs • MTD (or MAD) and RDE of IMP1734 as monotherapy and in combination with anti-cancer agents, Part 3: • Overall response rate, which is defined as the percentage of participants who have CR/PR per RECIST v1.1 by Investigator, and/or CA125 response per GCIG criteria (ovarian cancer), and/or PSA response per PCWG3 criteria.

Secondary

MeasureTime frame
PK parameters derived from plasma concentration data of IMP1734 and/or metabolites (if applicable) following single oral dose: • Cmax, Tmax, AUC0-t, AUC0-tau, Cmax(dn), and AUC0-tau(dn) • If data permit, AUC0-inf, CL/F, Vd/F, and t1/2, PK parameters derived from plasma concentration data of IMP1734 and/ormetabolites (if applicable) following multiple oral doses: • Cmax,ss, Ctrough, Tmax,ss, AUC0-t,ss, AUC0-tau,ss, Cmax,ss(dn), AUC0-tau(dn), Rac-Cmax,ss and Rac-AUC0-tau,ss, • If data permit, CL/F, Vd/F, and t1/2 • Overall response rate, which is defined as the percentage of participants who have CR/PR per RECIST v1.1, by Investigator and/or CA125 response per GCIG criteria (ovarian cancer), and/or PSA response per PCWG3 criteria., • Efficacy evaluated per RECIST v1.1 by Investigator: o ORR, which is defined as the percentage of participants who have CR/PR o DCR o DOR o TTR o Percentage change in sum of target lesions o CBR, which is defined as the proportion of participants with

Countries

Denmark, France, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026