Study of ART6043 in Advanced/Metastatic Solid Tumors Patients (POLKA)

Part of paid clinical trials in Grand Rapids, Michigan.

Sponsor
Artios Pharma Ltd
Study ID
NCT05898399
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumor
  • Metastatic Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ART6043 — DRUG
    ART6043 will be given orally.
  • Olaparib — DRUG
    Olaparib will be given orally.

Study Details

This interventional study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ART6043 as monotherapy or in combination with olaparib.

Key Dates

Start date
Jun 30, 2023
Status verified
Apr 2026
Primary completion
Jun 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
181 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A1 (ART6043 as monotherapy)
    Patients with advanced or metastatic cancer will receive ART6043 administered in 21-day cycles.
  • Experimental: Part A2 (ART6043 in combination with olaparib)
    Patients with advanced or metastatic cancer and with PARPi as an appropriate treatment option will receive ART6043 in combination with olaparib twice daily (BID) in 21-day cycles.
  • Experimental: Part B2 (ART6043 in combination with olaparib)
    Patients with gBRCA-m, HER2-ve locally advanced or metastatic breast cancer will be randomly assigned to receive ART6043 in combination with olaparib or olaparib alone.

Primary Outcome Measure

Part A: Number of participants with Dose Limiting Toxicities (DLTs) [ Time Frame: From first dose of study treatment until the end of Cycle 1 (each cycle is 21-days) ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
South Texas Accelerated Research Therapeutics (START) - MidwestGrand RapidsMichigan49546-
Memorial Sloan-Kettering Cancer Center (MSKCC)New YorkNew York10065-6800-
Stephenson Cancer Center - OncologyOklahoma CityOklahoma73104-
Jefferson University Hospitals - Kimmel Cancer CenterPhiladelphiaPennsylvania17107-
SCRI oncology partnersNashvilleTennessee37203-
Mary Crowley Cancer Center - ClinicDallasTexas75251-
The University of Texas - MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Grand Rapids, MI

By research site
South Texas Accelerated Research Therapeutics (START) - Midwest· Grand Rapids, MIMemorial Sloan-Kettering Cancer Center (MSKCC)· New York, NYStephenson Cancer Center - Oncology· Oklahoma City, OKJefferson University Hospitals - Kimmel Cancer Center· Philadelphia, PASCRI oncology partners· Nashville, TNMary Crowley Cancer Center - Clinic· Dallas, TX

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