NCT04657068 · Artios Pharma Ltd
A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors
What this study is about
This clinical trial is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors.
View original scientific description
This clinical trial is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors.
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.
Primary outcome measures
Part A: Maximum tolerated dose (MTD) by the number of participants with dose limiting toxicities (DLTs) from ART0380 monotherapy and in combination with gemcitabine or irinotecan
Time frame: From Cycle 0 Day -2 to Cycle 1 Day 21. Each cycle is 21 days.
Parts B1/B3/B4: Number of participants with adverse events following administration of ART0380 monotherapy and/or in combination with irinotecan at RP2Ds.
Time frame: From Cycle 1 Day 1 until up to 30 days after the last dose of ART0380. Each cycle is 21 days.
Safety reported as incidence of adverse events
Part B2: Progression free survival by RECIST 1.1 in participants receiving ART0380 in combination with gemcitabine or gemcitabine alone
Time frame: Every 6 weeks from Cycle 1 Day 1 for 18 weeks, then every 9 weeks up to approximately 24 months. Each cycle is 21 days.
Progression free survival (PFS)
Parts B5/B6: Object Response Rate (ORR) based on RECIST 1.1 to access anti-tumor activity of ART0380 in combination with irinotecan in each cohort.
Time frame: Every 6 weeks from Cycle 1 Day 1, until disease progression or death or start of a new anti-cancer therapy, up to 2 years. Each Cycle is 21 days.
Objective Response Rate (ORR)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Signed informed consent
- Have not received a previous treatment targeting the ATR/CHK1 pathway
- Discontinued all previous treatments for cancer for at least 21 days or 5 half-lives, whichever is shorter, and recovered from the acute effects of therapy to CTCAE Grade ≤1. Palliative radiotherapy must have completed 1 week prior to start of study treatment.
- If patients have a known germline BRCA mutation or a cancer with a somatic BRCA mutations or which is HRD positive and for which there is an approved PARP inhibitor, participants should have received such treatment before participating in the study unless contra-indicated
- At least 1 radiologically evaluable lesion (measurable and/or non-measurable) that can be assessed at baseline and is suitable for repeated radiological evaluation by RECIST v1.1 or Prostate Cancer Working Group-3 Guidelines (PCWG-3)
- Acceptable hematologic, renal, hepatic, and coagulation functions independent of transfusions and
Where
- Birmingham, Alabama
- Scottsdale, Arizona
- Little Rock, Arkansas
- Los Angeles, California
- Santa Barbara, California
- Santa Rosa, California
- Denver, Colorado
- Fort Myers, Florida
- Jacksonville, Florida
- Orlando, Florida
- Sarasota, Florida
- West Palm Beach, Florida
And 24 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 18, 2026 · Source of record for eligibility and locations