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A clinical study to assess the safety and efficacy of oral ART0380 as a single agent or in combination in solid tumors
EU CTIS ID: 2024-511534-12-00
What this study is testing
1. Part A: Safety and tolerability of ART0380 given orally in patients with advanced or metastatic solid tumors and to determine the maximum tolerated dose (MTD) and/or recommended Phase II doses/schedules (RP2Ds) of ART0380 as monotherapy, in combination with gemcitabine or in combination with irinotecan. 2. Parts B1/B3/B4: To further assess the safety and tolerability of ART0380 given orally as monotherapy, and/or ART0380 in combination with irinotecan RP2Ds. 3. Part B2: To compare the efficacy of ART0380 in combination with gemcitabine versus gemcitabine alone in patients with high grade serous ovarian, primary peritoneal or fallopian tube carcinoma that is resistant to platinum (PFI <6 months). 4. Parts B5/B6: To assess the efficacy of ART0380 in combination with irinotecan in patients with: ATM negative CRC that has previously been treated with a maximum of 2 prior chemotherapy regimens for advanced CRC (Part B5) ATM negative metastatic or locally advanced PDAC or acinar cell carcinoma that has previously been treated with a maximum of 1 prior chemotherapy regimen for advanced disease (Part B6).
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Discontinued all previous treatments for cancer for at least 21d or 5 half-lives, whichever is shorter, and recovered from the acute effects of therapy to CTCAE Grade ≤1. Palliative Rt completed 1 week prior to start of study treatment
- 10. Specific criteria for B1:•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 by RECIST v1.1• ECOG 0-1•Combination arms: pat. for which irinotecan is an appropriate treatment. Prior treatment with irino is permitted
- 11. Specific criteria for B5:• ATM negative (histologically confirmed unresectable adenocarcinoma of the colon or rectum •Patients must have a maximum of 2 prior chemotherapy regimens for the treatment of advanced CRC and have demonstrated progressive disease or intolerance to their last regimen.. .•Have at least 1 measurable lesion assessable by RECIST v1.1.
- 12. Specific criteria for Part B6 •Patients with ATM negativemetastatic or locally advanced PDAC or acinar cell carcinoma. •Patients have received a maximum of 1 prior chemotherapy regimen for the treatment of advanced disease and have demonstrated progressive disease or intolerance to this regimen OR have received neoadjuvant/adjuvant therapy with recurrence occurring <6 months following completion of this treatment. •Have at least 1 measurable lesion assessable by RECIST v1.1.
- 2. If known germline BRCA mutation or a cancer with a somatic BRCA mutation 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
- 3. 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
You likely can't join if
- 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
- 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.
See the full eligibility criteria
- 1. Discontinued all previous treatments for cancer for at least 21d or 5 half-lives, whichever is shorter, and recovered from the acute effects of therapy to CTCAE Grade ≤1. Palliative Rt completed 1 week prior to start of study treatment
- 10. Specific criteria for B1:•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 by RECIST v1.1• ECOG 0-1•Combination arms: pat. for which irinotecan is an appropriate treatment. Prior treatment with irino is permitted
- 11. Specific criteria for B5:• ATM negative (histologically confirmed unresectable adenocarcinoma of the colon or rectum •Patients must have a maximum of 2 prior chemotherapy regimens for the treatment of advanced CRC and have demonstrated progressive disease or intolerance to their last regimen.. .•Have at least 1 measurable lesion assessable by RECIST v1.1.
- 12. Specific criteria for Part B6 •Patients with ATM negativemetastatic or locally advanced PDAC or acinar cell carcinoma. •Patients have received a maximum of 1 prior chemotherapy regimen for the treatment of advanced disease and have demonstrated progressive disease or intolerance to this regimen OR have received neoadjuvant/adjuvant therapy with recurrence occurring <6 months following completion of this treatment. •Have at least 1 measurable lesion assessable by RECIST v1.1.
- 2. If known germline BRCA mutation or a cancer with a somatic BRCA mutation 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
- 3. 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
- 4. Have adequate organ function
- 5. Sufficient non-irradiated tumor tissue sample available for submission for analysis
- 6. 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 last dose
- 7. Estimated life expectancy of ≥12 weeks
- 8. Performance status of 0-1 on the ECOG scale
- 9. Specific criteria for A3:• Advanced or metastatic Ca for which irinotecan is an appropriate treatment. Prior irino. 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
- 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
- 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.
- Have a history of allergy or hypersensitivity to study drug components
- 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
- Exclusion criteria for A3/B1/B5/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 inhibitors of UGT1A1 within 2 weeks before the first dose of study treatment will be excluded •Part B5: Patients who have received fruquintinib or regorafenib or trifluridine/tipiracil.•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.
- Men who plan to father a child while in the study or within 5 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, hepatitis B virus, or hepatitis C virus; Documented active or chronic tuberculosis infection; have had or currently have a malignancy in addition to the one currently being treated that is not in remission
- Have ongoing interstitial lung disease or pneumonitis (whether symptomatic or asymptomatic).
- Have moderate or severe cardiovascular disease
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.