CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 442 target
Drug / intervention
ART0380 +2 moredrug
Likely dose
Not stated in record
Key inclusion· 12
  • ✓Signed informed consent
  • ✓ECOG performance status 0-1
  • ✓Recovered from prior therapy with ≤Grade 1 acute effects
  • ✓At least 1 radiologically evaluable lesion by RECIST v1.1 or PCWG-3
Key exclusion· 16
  • ✕Pregnant or breast-feeding women
  • ✕Plan to become pregnant during study or within 7 months of last dose (women) or 5 months (men)
  • ✕Serious concomitant systemic disorder including opportunistic HIV/AIDS, hepatitis B/C, active tuberculosis, or prior malignancy not in remission
  • ✕Ongoing interstitial lung disease or pneumonitis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04657068
NCT04657068Phase 2RecruitingHigh MomentumUpdated 3mo ago
Long Recruiting
CompareCT.gov

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

Artios Pharma Ltd·interventional·Posted Dec 8, 2020·Updated Mar 18, 2026

In Brief

A Phase 2 clinical trial evaluating ART0380, Gemcitabine, and 1 other intervention for Advanced Cancer and 8 related conditions. Currently recruiting, targeting 442 participants across 79 sites in 4 countries.

Signals

Enrolling ahead of pace

Detailed Summary

This clinical trial is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors. The main goals of this study are to: * Find the recommended dose of ART0380 that can be given safely to participants alone and in combination with gemcitabine or irinotecan * Learn more about the side effects of ART0380 alone and in combination with gemcitabine or irinotecan * Learn more about the effectiveness of ART0380 alone and in combination with gemcitabine or irinotecan

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Cancer, Metastatic Cancer, Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer, Endometrial Cancer, Metastatic Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Acinar Cell Carcinoma
CountriesFrance, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2Recruiting
20212022202320242025202620272028
First PostedDec 8, 2020
Enrollment StartJan 27, 2021
Primary CompletionDec 1, 2026
Study CompletionDec 1, 2027
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 5.6 years agoPrimary completion in 5 months

Interventions

ART0380drug

Participants will receive ART0380 by mouth either intermittently (either once daily 3 days on, 4 days off; days 2-4 and 9-11;or days 1-3 and 8-10) or continuously (once daily each day) in 21 day cycles.

Gemcitabinedrug

Gemcitabine will be administered on Days 1 and 8 of a 21-day cycle.

Irinotecandrug

Irinotecan will be administered as a 90-minute infusion on Days 1 and 8 of a 21 day cycle.