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Study of ART0380 in Advanced/Metastatic Solid Tumors Patients (ARTIST)
EU CTIS ID: 2023-504153-12-00
What this study is testing
To determine the efficacy of ART0380 in patients with solid tumors enrolled in each of the biologically defined arms.
- Therapeutic exploratory (Phase II)
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
- ≥18 years of age.
- Patients should have received taxane/platinum chemotherapy, unless contraindicated. (Arm 1)
- Measurable disease. (Arm 1)
- Advanced or metastatic solid cancers of any histology with biological selection. (Arm 2)
- If a PD-1/PDL-1 inhibitor (e.g., pembrolizumab) is approved and available for the patient’s cancer, the patient should have received such treatment before participating in this study. (Arm 2)
- Radiologically evaluable disease. (Arm 2)
You likely can't join if
- Patients who are pregnant.
- Patients receiving the following within 2 weeks of the first dose will be excluded from study treatment. a. PgP or BCRP inhibitors. b. statins.
- Patients who plan to father a child while in the study or within 16 weeks after the last administration of study treatment. (Arm 2)
- Prior treatment with an inhibitor of ATR, WEE1, CHK1 or PKMYT1.
- Have a serious concomitant systemic disorder that would compromise the patient’s ability to adhere to the protocol.
- Have ongoing interstitial lung disease or pneumonitis (whether symptomatic or asymptomatic).
See the full eligibility criteria
- ≥18 years of age.
- Patients should have received taxane/platinum chemotherapy, unless contraindicated. (Arm 1)
- Measurable disease. (Arm 1)
- Advanced or metastatic solid cancers of any histology with biological selection. (Arm 2)
- If a PD-1/PDL-1 inhibitor (e.g., pembrolizumab) is approved and available for the patient’s cancer, the patient should have received such treatment before participating in this study. (Arm 2)
- Radiologically evaluable disease. (Arm 2)
- Have discontinued all previous treatments for cancer for at least 21 days or 5 half-lives (not including palliative radiotherapy at focal sites), whichever is shorter. Palliative radiotherapy must have completed 1 week prior to start of study treatment.
- Resolution of all toxicities of prior therapy or surgical procedures to baseline or Grade 1 (except for hypothyroidism requiring medication, neuropathy, and alopecia, which must have resolved to Grade ≤2).
- Have adequate organ function.
- Patients of childbearing potential and patients with partners of childbearing potential are required to use highly effective contraception.
- Have an estimated life expectancy of ≥12 weeks, in the judgment of the investigator.
- Performance status of 0-1 on the ECOG scale.
- Have a sufficient non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available.
- Persistent or recurrent Endometrial Cancer with biological selection. (Arm 1)
- Patients who are pregnant.
- Patients receiving the following within 2 weeks of the first dose will be excluded from study treatment. a. PgP or BCRP inhibitors. b. statins.
- Patients who plan to father a child while in the study or within 16 weeks after the last administration of study treatment. (Arm 2)
- Prior treatment with an inhibitor of ATR, WEE1, CHK1 or PKMYT1.
- Have a serious concomitant systemic disorder that would compromise the patient’s ability to adhere to the protocol.
- Have ongoing interstitial lung disease or pneumonitis (whether symptomatic or asymptomatic).
- Patients with treated brain metastases are eligible if followup brain imaging after central nervous system (CNS) directed therapy shows no evidence of progression.
- Have any major GI issue that could impact absorption of ART0380.
- Have a history of allergy or hypersensitivity to study drug components.
- Have a significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 12 weeks prior to enrollment.
- Patients receiving potent inhibitors and inducers of CYP3A4 or CYP3A4 substrates which have a narrow therapeutic range or CYP3A4 sensitive substrates within 2 weeks before the first dose of study treatment will be excluded.
The study team makes the final eligibility decision.
Where it's taking place
- United States
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. 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.