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Looking for participantsPhase1/Phase2

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

Sponsor: Artios Pharma Ltd

NCT ID: NCT04657068

View on ClinicalTrials.gov ↗

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.

Advanced CancerMetastatic CancerOvarian CancerPrimary Peritoneal CancerFallopian Tube CancerEndometrial CancerMetastatic Colorectal CancerPancreatic Ductal AdenocarcinomaAcinar Cell Carcinoma

How this trial compares with your answers

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What we know so far

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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

HRDHRD positive

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
General Inclusion Criteria: * Signed informed consent * 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 granulocyte colony-stimulating factor * Non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available for submission for analysis. * Female patients of childbearing potential and male patients with female partners of childbearing potential are required to use highly effective contraception plus one barrier method during their participation in the study and for 7 months and 5 months respectively following the last dose. For male and female patients given gemcitabine or irinotecan, highly effective contraception plus one barrier method must be used from study entry until 6 months after the last dose of study treatment. Male patients are required to refrain from donating sperm and female patients are required to refrain from donating eggs, during their participation in the study and for 6 months following last dose. * 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 procedures * Performance status of 0-1 on the ECOG Scale Additional inclusion criteria for participants in dose escalation (Part A1): * Advanced or metastatic cancer which is refractory to standard therapies, or for which no standard therapies exist, or for which the investigator feels no other active therapy is required for the duration of the study * Performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale Additional inclusion criteria for participants in dose escalation (Part A2): •Advanced or metastatic cancer for which gemcitabine is an appropriate treatment. Prior treatment with gemcitabine is permitted. Additional inclusion criteria for participants in dose escalation (Part A3): * Advanced or metastatic cancer for which irinotecan is an appropriate treatment. Prior treatment with irinotecan is permitted. * For food effect cohort only: Patients must be able to eat a high-fat meal within a 30 minute period, as provided by the study site. Additional inclusion criteria for participants in dose expansion (Part B1): * Patients with advanced or metastatic solid tumors with alterations to the ATM gene likely to predict for loss of ATM protein * Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1 * For France only ART0380 Monotherapy; Patient that is not eligible for curative treatment, for whom all standard of care therapies have failed and no therapies known to provide clinical benefit are available. * Combination arms; Patients for which irinotecan is an appropriate treatment. Prior treatment with irinotecan is permitted. * For Spain only ART0380 Combination therapy, Patient that is not eligible for curative treatment, for whom standard of care therapies have failed. Additional inclusion criteria for participants in dose expansion (Part B2): * Patients with a known germline BRCA mutation, or a cancer with a known somatic BRCA mutation, or which is known to be HRD positive, and for which there is an approved PARP inhibitor should have received such treatment before participating in the study, unless contra-indicated. * Females with histologically-confirmed diagnosis of high grade serous carcinoma of the ovary, fallopian tube or primary peritoneum that is not amenable to curative therapy * Platinum-resistant disease. Patients must not have had primary platinum-refractory disease (disease that progressed during first-line platinum-based therapy). * No more than one prior regimen in the platinum-resistant setting. Hormonal therapies and antiangiogenic therapies (as single agents) and PARP inhibitors used as maintenance therapy are not considered as separate lines of therapy. Patients should have previously received bevacizumab and chemotherapy unless contra-indicated. * Have not received prior treatment with gemcitabine unless administered in combination with a platinum with no disease progression within 12 months after completion of that regimen * Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1 Inclusion criteria specific to Part B3 * Persistent or recurrent endometrial cancer with biological selection.: * Patients should have received taxane/platinum chemotherapy, unless contraindicated. * Measurable disease. Inclusion criteria specific to Part B4 * Advanced or metastatic solid cancers of any histology with biological selection * If a PD-1/PDL-1 inhibitor (eg, pembrolizumab) is approved and available for the patient's cancer, the patient should have received such treatment before participating in this study. * Radiologically evaluable disease * Performance status of 0-1 on the ECOG scale Inclusion criteria specific to Part B5 * Metastatic CRC with alterations to the ATM gene * Participants should have previously received appropriate prior lines of therapy in this setting. * Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1. * Patients have received a maximum of 2 prior chemotherapy regimens for the treatment of CRC. * Serum albumin ≥3g/dL within 7 days prior to first dose. * ECOG Performance Status must be stable for at least 2 weeks prior to enrollment. * Must have the clinical capacity to complete at least one 21-day treatment cycle without, in the investigator's judgment, a foreseeable need for prolonged hospitalization related to their underlying disease Inclusion criteria specific to Part B6: * Metastatic or locally advanced PDAC or acinar cell carcinoma with alterations to the ATM gene * Participants must have received at least 1 prior chemotherapy regimen for the treatment of the advanced disease OR have received neoadjuvant/adjuvant therapy with recurring occurring \<6 months following completion of this treatment. * Have at least 1 measurable lesion assessable using standard techniques by RECIST v1.1. Previously irradiated lesions may not be considered target lesions. * Serum albumin ≥3g/dL within 7 days prior to first dose. * ECOG Performance Status must be stable for at least 2 weeks prior to enrollment. * Must have the clinical capacity to complete at least one 21-day treatment cycle without, in the investigator's judgment, a foreseeable need for prolonged hospitalization related to their underlying disease. General Exclusion Criteria: * Women who are pregnant, breast feeding, or who plan to become pregnant while in the study or within 7 months after the last administration of study treatment * Men who plan to father a child while in the study or within5 months after the last administration of study treatment * Serious concomitant systemic disorder that would compromise the participants ability to adhere to the protocol including: one or more opportunistic HIV/AIDs-related infections within the past 12 months, a known hepatitis B virus, or known hepatitis C virus; documented active or chronic tuberculosis infection; malignancy prior to the one currently being treated that is not in remission * Have ongoing interstitial lung disease or pneumonitis (whether symptomatic or asymptomatic). * Moderate or severe cardiovascular disease * Valvulopathy that is severe, moderate, or deemed clinically significant * Documented major electrocardiogram (ECG) abnormalities which are clinically significant * Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment * Received a live vaccine within 30 days before the first dose of study treatment * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate * Recent major surgery within 4 weeks prior to entry into the study or minor surgery within 1 week of entry into the study * Drainage for ascites, pleural effusion or pericardial fluid within 4 weeks before the first dose of study treatment. * A significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 12 weeks prior to enrollment * Currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study Additional exclusion criteria for participants in dose escalation (Part A3, B1, B5, and B6 in combination with irinotecan): * Patients who have symptoms or signs of clinically unacceptable deterioration of the primary disease at the time of screening. * Patients who are known to be homozygous for both UGT1A1 \*6 and \*28 (UGT1A1 7/7 genotype), or simultaneously heterozygous for both UGT1A1 \*6 and \*28. * Patients receiving strong inhibitors of UGT1A1 within 2 weeks before the first dose of study treatment * Part A3 Fed-fasted cohort only: Patients receiving acid reducing agents within 1 week before the first dose of study treatment will be excluded * Part B6: Neuroendocrine (carcinoid, islet cell) or adenosquamous carcinoma pancreatic cancer * Parts B5 and B6: Initiation of opioids in the previous 2 weeks. * Parts B5 and B6: Weight loss \>10% in the previous 8 weeks. * Parts B5 and B6: Active intestinal obstruction, ileus, or significant malabsorption.

Where Is This Study? (4 UK sites)

Beatson West of Scotland Cancer Centre

Glasgow G12 0YN, United Kingdom

Recruiting
Hospital R&D contact (matched)

Jennifer McLean

jennifer.mclean@health.scot.nhs.uk0131 537 4718

Guy's and St Thomas' NHS Foundation Trust

London SE1 9RT, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

Sarah Cannon Research Institute UK

London W1G 6AD, United Kingdom

Recruiting

The Christie NHS Foundation Trust - The Christie Clinic

Manchester M20 4BX, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research and Innovation Office

the-christie.ri@nhs.net---

How to Get in Touch

Sarah Cannon Development Innovations

Sponsor contact

CONTACT

844-710-6157 SCRI.InnovationsMedical@scri.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-07