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A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

NCT04657068 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 442

Last updated 2026-03-18

No results posted yet for this study

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

Conditions

Interventions

DRUG

ART0380

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.

DRUG

Gemcitabine

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

DRUG

Irinotecan

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

Sponsors & Collaborators

  • Artios Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Melissa Johnson, MD · Tennessee Oncology

  • Antonio Gonzalez, MD, PHD · Clinica Universidad de Navarra, Madrid

  • Susanna Ulahannan, MD · Oklahoma University

  • Kim Reiss Binder, MD · University of Pennsylvania / Abramson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-27
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States
  • France
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04657068 on ClinicalTrials.gov