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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.

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-520395-99-00
Acronym
EIK1004-001
Enrollment
42
Registered
2025-07-14
Start date
2025-08-12
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Advanced solid tumors

Brief summary

• Dose-limiting toxicities (DLTs), • Adverse events (AEs)

Detailed description

• PK parameters derived from plasma concentration data of EIK1004 and/or metabolites (if applicable) following single oral dose, • PK parameters derived from plasma concentration data of EIK1004 and/or metabolites (if applicable) following multiple oral doses, • Objective Response (OR), • Disease Control (DC), • Duration of Response (DOR), • Time to response (TTR), • Percentage change from Baseline in sum of target lesions., • Clinical benefit (CB), • Time to CNS progression

Interventions

DRUGEIK1004 5mg Tablets
DRUGEIK1004 20mg Tablets

Sponsors

Eikon Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
• Dose-limiting toxicities (DLTs), • Adverse events (AEs)—

Secondary

MeasureTime frame
• PK parameters derived from plasma concentration data of EIK1004 and/or metabolites (if applicable) following single oral dose, • PK parameters derived from plasma concentration data of EIK1004 and/or metabolites (if applicable) following multiple oral doses, • Objective Response (OR), • Disease Control (DC), • Duration of Response (DOR), • Time to response (TTR), • Percentage change from Baseline in sum of target lesions., • Clinical benefit (CB), • Time to CNS progression—

Countries

Denmark, France, Portugal, Spain

Outcome results

None listed

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