Study of ART6043 in Advanced/Metastatic Solid Tumors Patients (POLKA) (NCT05898399) | Clinical Trial Compass
RecruitingPhase 1/2
Study of ART6043 in Advanced/Metastatic Solid Tumors Patients (POLKA)
United States181 participantsStarted 2023-06-30
Plain-language summary
This interventional study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ART6043 as monotherapy or in combination with olaparib.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Patients who have discontinued all previous chemotherapeutic agents, non-hormonal targeted therapy, or investigational drugs for at least 21 days or 5 half-lives (not including palliative radiotherapy at focal sites), whichever is shorter. Endocrine and hormonal therapies for the treatment of cancer must have been discontinued (unless for the treatment of Prostate Cancer) at least 7 days before receiving study medication. Palliative radiotherapy must have completed prior to start of study treatment.
* Resolution of all toxicities of prior therapy or surgical procedures.
* Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale.
* 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.
Inclusion Criteria specific to Part A1 (ART6043 as Monotherapy)
• Advanced or metastatic cancer. Tumors with genetic lesions known to cause loss of function of known DDR genes based on available pre-existing testing are encouraged.
Inclusion criteria specific to Part A2 (ART6043 in combination with olaparib)
* Advanced or metastatic cancer with genetic lesions known to cause loss of function of known DDR genes based on available, pre-existing testing.
* Patients for whom a PARPi is an appropriate treatment option. Patients may have received prio…
What they're measuring
1
Part A: Number of participants with Dose Limiting Toxicities (DLTs)
Timeframe: From first dose of study treatment until the end of Cycle 1 (each cycle is 21-days)
2
Part B2: Progression free survival (PFS)
Timeframe: Until disease progression (Upto 3.7 years).