At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- ART0380 (drug), Gemcitabine (drug), Irinotecan (drug)
- How long the study runs
- Study runs about 89 months (dates as stated)
- About the drug or intervention
- ART0380 — drug: 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. · Gemcitabine — drug: Gemcitabine will be administered on Days 1 and 8 of a 21-day cycle. · Irinotecan — drug: Irinotecan will be administered as a 90-minute infusion on Days 1 and 8 of a 21 day cycle.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is testing a new drug called ART0380, on its own or with other cancer drugs (gemcitabine or irinotecan), in people with advanced or spread (metastatic) solid tumours. These include ovarian, fallopian tube, primary peritoneal, womb (endometrial), bowel, and pancreatic cancers. The study looks at different doses and groups of patients, including some whose tumours have changes in a gene called ATM or BRCA.
Who can take part
- Adults with advanced or metastatic solid tumours, including ovarian, fallopian tube, primary peritoneal, endometrial, metastatic bowel, and pancreatic cancers
- People who have stopped previous cancer treatment for at least 21 days (or 5 half-lives, if shorter) and have recovered from the worst side effects
- People with at least one tumour that can be seen on scans and measured again during the study
- A tumour tissue sample (from stored tissue or a new biopsy) must be available for testing
- Good blood, kidney, liver, and clotting function without transfusions or growth factor support
- Able to carry out normal activities with little or no restriction (performance status 0-1 on the ECOG scale)
- Expected to live at least 12 weeks
- Some parts of the study need tumours with ATM gene changes; others need BRCA changes or specific cancer types and previous treatments
- Use of highly effective contraception plus a barrier method during the study and for several months after the last dose (7 months for women, 5 months for men, or 6 months if given gemcitabine or irinotecan)
Who may not be able to
- Women who are pregnant, breastfeeding, or planning pregnancy during the study or within 7 months after the last dose
- Men planning to father a child during the study or within 5 months after the last dose
- Serious other illnesses, such as certain HIV-related infections, hepatitis B or C, active tuberculosis, or another cancer not in remission
- Ongoing lung disease called interstitial lung disease or pneumonitis
- Moderate or severe heart disease, significant heart valve problems, or major clinically significant ECG (heart tracing) abnormalities
- Symptomatic or uncontrolled cancer spread to the brain, spinal cord compression, or leptomeningeal disease needing treatment at the same time
- Live vaccines within 30 days before the first dose
- Major surgery within 4 weeks, or minor surgery within 1 week, before joining the study
- Fluid drainage (for fluid in the abdomen, around the lungs, or around the heart) within 4 weeks before the first dose
- Significant bleeding disorders or a serious bleed within 12 weeks before joining
- Already taking part in another clinical trial of an experimental treatment
- For parts using irinotecan: certain inherited UGT1A1 gene types, taking strong UGT1A1-blocking drugs within 2 weeks, or worsening disease symptoms at screening
- For the bowel and pancreatic cancer parts: newly started opioids within 2 weeks, more than 10% weight loss in 8 weeks, or active bowel blockage or malabsorption
What taking part involves
- • Taking the study drug ART0380 by itself or together with gemcitabine or irinotecan, depending on the study part
- • Treatment is given in 21-day cycles, repeated for at least one cycle
- • Having regular scans to check whether the tumour changes during the study
- • Providing a tumour tissue sample for laboratory testing
Time commitment: Not stated — ask the trial team (details such as how many visits, how long treatment lasts, and whether the drug is a tablet or injection are not given in this data; treatment runs in 21-day cycles).
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 542
- Started
- 2021-01-27
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for advanced cancer
- • Phase1/Phase2 - 542 participants
- • This clinical trial is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with advanced cancer
Where?
- • Glasgow - Beatson West of Scotland Cancer Centre
- • London - Guy's and St Thomas' NHS Foundation Trust
- • London - Sarah Cannon Research Institute UK
- • Manchester - The Christie NHS Foundation Trust - The Christie Clinic
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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
More detail
ART0380 is a new investigational medicinal product that is a potent and selective inhibitor of Ataxia telangiectasia and Rad3-related (ATR). ART0380 is being developed as an oral anti-cancer agent for the treatment of participants with cancers that harbor defects in deoxyribonucleic acid (DNA) repair and in combination with agents including those that cause DNA damage. This study is an open-label Phase I/IIa study designed to evaluate the safety, tolerability, PK and preliminary efficacy of ART0380 as monotherapy or in combination with gemcitabine or irinotecan in participants with advanced or metastatic solid tumors, advanced or solid tumors that fail to express Ataxia-Telangiectasia Mutated protein kinase (ATM), and high grade serous ovarian, primary peritoneal or fallopian tube carcinoma.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ completed 1 week
- ✓ for the duration of the study
- ✓ gemcitabine is permitted
- ✓ irinotecan is permitted
What the study is looking for
- ✓Signed agreement to take part
- ✓Acceptable blood, kidney, liver, and coagulation functions independent of transfusions and granulocyte...
- ✓Non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available for...
- ✓Estimated life expectancy of ≥12 weeks
- ✓Reliable and willing to make themselves available for the duration of the study and are willing to follow study...
Who cannot take part
- ✗Women who are pregnant, breast feeding, or who plan to become pregnant while in the study or within 7 months after...
- ✗Men who plan to father a child while in the study or within5 months after the last administration of study treatment
- ✗Have ongoing interstitial lung disease or pneumonitis (whether causing symptoms or not causing symptoms).
- ✗Moderate or severe cardiovascular disease
- ✗Valvulopathy that is severe, moderate, or deemed clinically significant
See the full criteria
Where Is This Study? (4 UK sites)
Beatson West of Scotland Cancer Centre
Glasgow G12 0YN, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London SE1 9RT, United Kingdom
Sarah Cannon Research Institute UK
London W1G 6AD, United Kingdom
The Christie NHS Foundation Trust - The Christie Clinic
Manchester M20 4BX, United Kingdom
How to Get in Touch
Sarah Cannon Development Innovations
Sponsor contactCONTACT
