Phase 2 Ovarian Cancer Trial, Recruiting NCT04657068 Sponsor: Artios Pharma Ltd Condition: Ovarian Cancer
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Phase 2 Ovarian Cancer Trial, Recruiting

NCT04657068
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • A person who has signed a consent form agreeing to take part in the study.
  • A person whose previous cancer treatments ended at least 21 days ago (or a shorter period based on the specific drug used), and whose side effects from those treatments have mostly resolved.
  • A person who has at least one area of cancer that can be seen and measured on a scan, and that can be checked again over time.
  • A person whose blood counts, kidney function, liver function, and blood clotting results are within an acceptable range without needing transfusions or growth factor support.
  • A person who has a tumour tissue sample available (either stored from a previous biopsy or from a new biopsy) that can be sent for testing.
  • A person who is willing and able to use highly effective contraception plus a barrier method during the study and for a period after the last dose (the exact timeframe depends on which treatments are received and whether the person can become pregnant or father a child).
  • A person who is expected to live for at least 12 weeks.
  • A person who is willing to attend all required study visits and follow the study procedures.
  • A person whose general physical condition is rated 0 or 1 on the ECOG performance scale, meaning they are fully active or restricted in strenuous activity but able to carry out light work (confirm with trial site if unsure what this means for a specific situation).
  • A person with certain gene changes (such as ATM gene alterations, BRCA mutations, or HRD-positive cancer) depending on which part of the trial they are being considered for (confirm specific requirements with the trial site).
  • For some parts of the trial, a person whose cancer is advanced or has spread and has not responded to standard treatments, or for whom no standard treatments exist.
  • For some parts of the trial, a person with a specific cancer type, such as high-grade serous ovarian, fallopian tube or peritoneal cancer; endometrial cancer; colorectal cancer; or pancreatic cancer — each with additional specific requirements (confirm details with the trial site).
  • For some parts of the trial, a person who has previously received certain treatments (such as platinum-based chemotherapy, taxane chemotherapy, PARP inhibitors, or PD-1/PD-L1 inhibitors) where those treatments are approved and available for their cancer type, unless those treatments were not suitable for them.

Who may not be able to join:

  • A person who is pregnant, breastfeeding, or planning to become pregnant during the study or within 7 months after the last dose of study treatment.
  • A person who plans to father a child during the study or within 5 months after the last dose.
  • A person with a serious ongoing illness that would make it difficult to follow the study requirements, including active HIV-related infections in the past 12 months, active hepatitis B or C, active tuberculosis, or another cancer that is not currently in remission.
  • A person who has ongoing lung inflammation (interstitial lung disease or pneumonitis), whether or not it is causing symptoms.
  • A person with moderate or severe heart or cardiovascular disease.
  • A person with significant heart valve problems.
  • A person with significant abnormalities on a heart tracing (ECG) that are considered clinically important.
  • A person with brain metastases, spinal cord compression, or cancer affecting the lining of the brain or spinal cord that is causing symptoms or is not well controlled, and that requires ongoing treatment.
  • A person who received a live vaccine within 30 days before the first dose of study treatment.
  • A person who has any other condition, previous treatment, or test result that could interfere with the study results or make participation not in their best interest (confirm with trial site).
  • A person who had major surgery within 4 weeks before joining the study, or minor surgery within 1 week before joining.
  • A person who had fluid drained from around their abdomen, lungs, or heart within 4 weeks before the first dose.
  • A person with a significant bleeding disorder or who had a serious bleeding episode within 12 weeks before joining.
  • A person who is already taking part in another clinical trial involving an investigational treatment.
  • For parts of the trial involving irinotecan: a person with a specific inherited difference in how their body processes irinotecan (related to the UGT1A1 gene — confirm with trial site), or a person taking certain medications that affect this process within 2 weeks before the first dose.
  • For the pancreatic cancer part of the trial (Part B6): a person with a neuroendocrine or adenosquamous type of pancreatic cancer.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 12 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Melissa Johnson, MD, Tennessee Oncology

Phone: 844-710-6157

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Artios Pharma Ltd
Registry
ClinicalTrials.gov
Start date
27 January 2021
Est. completion
1 December 2026

Where this trial is recruiting

🇫🇷 France 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

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; Parts B1/B3/B4: Number of participants with adverse events following administration of ART0380 monotherapy and/or in combination with irinotecan at RP2Ds.; Part B2: Progression free survival by RECIST 1.1 in participants receiving ART0380 in combination with gemcitabine or gemcitabine alone; Parts B5/B6: Object Response Rate (ORR) based on RECIST 1.1 to access anti-tumor activity of ART0380 in combination with irinot...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 12 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov