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A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the DNA Polymerase Theta Inhibitor ART6043 Administered Orally as Monotherapy and in Combination to Patients with Advanced or Metastatic Solid Tumors

Status
Not yet recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-509220-17-00
Acronym
ART6043C001
Enrollment
55
Registered
2024-07-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-12

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

Conditions

Metastatic solid tumors, Advanced solid tumors

Brief summary

Part A: Incidence of Dose Limiting Toxicities (DLTs); incidence and severity of Adverse Events (CTCAE v5.0), Part B1: Incidence and severity of adverse events (CTCAE v5.0), Part B2: Progression free survival (PFS) (based on RECIST v1.1)

Detailed description

Part B2: Incidence and severity of Adverse events (CTCAE v5.0), Best overall response (BOR), Objective Response Rate (ORR), Disease control rate (DCR), Duration of response (DOR) and change in tumor size, Serological tumor markers, Part A and B1: Progression free survival (PFS), Overall survival (OS), ART6043 and ART7276 plasma concentration data, ART6043 Urine concentration data, Olaparib and niraparib plasma concentration data, Archival tumor or pre-dose tumor biopsy

Interventions

DRUGLynparza 150 mg film-coated tablets
DRUGART6043
DRUGLynparza 100 mg film-coated tablets
DRUGZejula 100 mg film-coated tablets

Sponsors

Artios Pharma Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Part A: Incidence of Dose Limiting Toxicities (DLTs); incidence and severity of Adverse Events (CTCAE v5.0), Part B1: Incidence and severity of adverse events (CTCAE v5.0), Part B2: Progression free survival (PFS) (based on RECIST v1.1)—

Secondary

MeasureTime frame
Part B2: Incidence and severity of Adverse events (CTCAE v5.0), Best overall response (BOR), Objective Response Rate (ORR), Disease control rate (DCR), Duration of response (DOR) and change in tumor size, Serological tumor markers, Part A and B1: Progression free survival (PFS), Overall survival (OS), ART6043 and ART7276 plasma concentration data, ART6043 Urine concentration data, Olaparib and niraparib plasma concentration data, Archival tumor or pre-dose tumor biopsy—

Countries

Spain

Outcome results

None listed

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