Study of ART6043 in Advanced/Metastatic Solid Tumors Patients (POLKA)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorArtios Pharma Ltd
About this trial
This interventional study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ART6043 as monotherapy or in combination with olaparib.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 14 days prior to randomization.
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.
Disqualifiers
Patients who are pregnant.
Patients with Myelodysplastic syndrome (MDS)/Acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
Have ongoing interstitial lung disease or pneumonitis.
Have any major gastrointestinal issues that could impact absorption of ART6043 or olaparib.
Trial design
Design model
Sequential
Treatments tested in this trial
ART6043
DrugART6043 will be given orally.
Olaparib
DrugOlaparib will be given orally.
Treatment groups
181 Participants
are divided into 3 treatment groupsGroup A: Part A1 (ART6043 as monotherapy)Experimental treatment 1 intervention
Group B: Part A2 (ART6043 in combination with olaparib)Experimental treatment 2 interventions
Group C: Part B2 (ART6043 in combination with olaparib)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Part A: Number of participants with Dose Limiting Toxicities (DLTs)
Severity of adverse events as assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame
From first dose of study treatment until the end of Cycle 1 (each cycle is 21-days)2
Part B2: Progression free survival (PFS)
PFS is defined as the time from randomization until objective disease progression as defined by Response evaluation criteria in solid tumors (RECIST) v1.1 or death by any cause in the absence of progression, regardless of whether the patient withdraws from study medication or receives another anti-cancer therapy prior to progression.
Time frame
Until disease progression (Upto 3.7 years).Secondary outcomes
1
Part B2: Number of participants with Adverse events
To assess the safety and tolerability of ART6043 given orally in combination with olaparib at the Recommended Phase II dose(s) \[RP2D(s)\].
Time frame
Screening (≤28 days) Until follow-up visit (90 days after discontinuation)] (up to 3.7 years)2
Best overall response (BOR)
The best overall response is the best response (complete response \[CR\] or partial response \[PR\]) recorded from the date of randomization for each patient until the progression or censoring date in the absence of progression.
Time frame
Screening (≤28 days) Until disease progression/recurrence (Upto 3.7 years)3
Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as the proportion of patients with a CR or PR to treatment according to RECIST v1.1.
Time frame
Screening (≤28 days) Until disease progression/recurrence (Upto 3.7 years)4
Disease control rate (DCR)
To assess preliminary signs of efficacy for ART6043 as monotherapy and in combination with olaparib.
Time frame
Screening (≤28 days) Until disease progression (Upto 3.7 years)Sponsors and contacts
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Source ClinicalTrials.gov