A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of the ATR Kinase Inhibitor ART0380 Administered Orally as Monotherapy and in Combination to Patients with Advanced or Metastatic Solid Tumors

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511534-12-00

Acronym

ART0380C001

Enrollment

140

Registered

2024-10-28

Start date

2025-06-10

Completion date

Unknown

Last updated

2025-10-28

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

Conditions

Advanced or Metastatic Solid Tumours

Brief summary

Part A: Incidence of dose-limiting toxicities (DLTs), Parts B1/B3/B4/B5: Incidence and severity of AEs (CTCAE v5.0), Part B2: Progression free survival (RECIST v1.1)

Detailed description

Part B2 Incidence and severity of AEs, ART0380 Plasma concentration data., ART0380 renal clearance data, Part A and part B1/B3/B4/B5: Objective Response Rate, Duration of Response (based on RECIST v1.1). Progression free survival, Part B2: Objective Response Rate, Duration of Response (based on RECIST v1.1)., Archival tumor or pre-dose tumor biopsy: Correlation of lesions in (or indicative of lesions in) DNA repair pathways, Irinotecan and its metabolite SN-38 plasma concentration data, Plasma concentration data • Single dose PK parameters of ART0380 administered in fasting and fed states

Interventions

DRUGART0380

DRUGGEMCITABINE

DRUGIRINOTECAN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part A: Incidence of dose-limiting toxicities (DLTs), Parts B1/B3/B4/B5: Incidence and severity of AEs (CTCAE v5.0), Part B2: Progression free survival (RECIST v1.1)	—

Secondary

Measure	Time frame
Part B2 Incidence and severity of AEs, ART0380 Plasma concentration data., ART0380 renal clearance data, Part A and part B1/B3/B4/B5: Objective Response Rate, Duration of Response (based on RECIST v1.1). Progression free survival, Part B2: Objective Response Rate, Duration of Response (based on RECIST v1.1)., Archival tumor or pre-dose tumor biopsy: Correlation of lesions in (or indicative of lesions in) DNA repair pathways, Irinotecan and its metabolite SN-38 plasma concentration data, Plasma concentration data • Single dose PK parameters of ART0380 administered in fasting and fed states	—

Measure

Time frame

—

Countries

France, Spain

Outcome results

None listed

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