Study of ART0380 in Patients With Biologically Selected Solid Tumors (NCT05798611) | Clinical Trial Compass
TerminatedPhase 2
Study of ART0380 in Patients With Biologically Selected Solid Tumors
Stopped: Sponsor decision, not for reasons affecting the benefit-risk balance.
United States36 participantsStarted 2023-09-06
Plain-language summary
This interventional study will evaluate the efficacy and safety of ART0380 as monotherapy in patients whose tumors have a biology to predict for sensitivity to inhibition of Ataxia-Telangiectasia Mutated and Rad3-related protein kinase (ATR).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients who 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 Eastern Cooperative Oncology Group scale.
* Have a non-irradiated tumor tissue sample (archival or newly obtained core biopsy of a tumor lesion) available.
Inclusion Criteria specific to each Arm
Inclusion Criteria for Arm 1 \[ART0380 monotherapy (endometrial cancer patients)\]
* Persistent or recurrent EC with biological selection.
* Patients should have received taxane/platinum chemotherapy unless contraindicated.
* Measurable disease.
Inclusion Criteria for Arm 2 \[ART0380 monotherapy (solid tumors patients)\]
* Advanced or metastatic solid cancers of any histology with biological selection.
* If a Programmed cell death protein-1 /Programmed death-ligand-1 inhibitor (e.g., pembrolizumab) i…
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: Until disease progression (Every 6 weeks from randomization Upto 2 Years)