A Study of ART4215 for the Treatment of Advanced or Metastatic Solid Tumors

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Artios Pharma Ltd
Study ID
NCT04991480
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • ART4215 — DRUG
    Participants will receive ART4215 by mouth daily in 21-day cycles.
  • Talazoparib — DRUG
    Talazoparib will be administered at a dose of 1 mg or 0.75 mg by mouth daily in 21-day cycles.
  • Niraparib — DRUG
    Niraparib will be administered at a dose of 200 mg or 300 mg by mouth daily in 21-day cycles.

Study Details

This clinical trial is evaluating a drug called ART4215 in participants with advanced or metastatic solid tumors. The main goals of this study are to: * Find the recommended dose of ART4215 that can be given safely to participants alone and in combination with talazoparib * Learn more about the side effects of ART4215 alone and in combination with talazoparib * Learn more about the effectiveness of ART4215 alone and in combination with talazoparib * Learn more about the effectiveness of ART4215 alone and in combination with niraparib

Key Dates

Start date
Sep 13, 2021
Status verified
Jan 2026
Primary completion
Dec 24, 2025
Completion
Dec 24, 2025

Study Design

Enrollment
93 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A1
    Part A1 will evaluate ART4215 monotherapy administered in 21 day cycles. Up to 90 participants will participate in this dose escalation arm.
  • Experimental: Part A2
    Part A2 will evaluate ART4215 given in combination with talazoparib in 21 day cycles. Up to 50 participants will participate in this dose escalation arm.
  • Experimental: Part B1
    In Part B1 dose expansion, up to 30 participants with solid cancers that have been treated with a PARP inhibitor for an approved indication will receive ART4215.
  • Experimental: Part B2
    In Part B2 dose expansion, up to 20 participants with solid cancers with characteristics indicative of sensitivity to pol theta inhibition will receive ART4215.
  • Experimental: Part B3
    In Part B3, approximately 120 participants with HER2 negative BRCA breast cancers will be randomized 1:1 to either ART4215 in combination with talazoparib or talazoparib alone.
  • Experimental: Part A3
    Part A3 will evaluate ART4215 given in combination with niraparib in 21-day cycles. Up to 30 participants will participate in this dose escalation arm.

Primary Outcome Measure

Part A: Number of participants with dose limiting toxicities (DLTs) from ART4215 monotherapy, in combination with talazoparib or in combination with niraparib [ Time Frame: 21 days (Cycle 1) ]

Locations (7)

FacilityCityStateZIPSite coordinators
Yale School of MedicineNew HavenConnecticut06520-
Florida Cancer SpecialistsOrlandoFlorida32827-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Oklahoma UniversityOklahoma CityOklahoma73104-
University of Pennsylvania/Abramson Cancer CenterPhiladelphiaPennsylvania19104-
Tennessee OncologyNashvilleTennessee37203-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in New Haven, CT

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Yale School of Medicine· New Haven, CTFlorida Cancer Specialists· Orlando, FLMemorial Sloan Kettering Cancer Center· New York, NYOklahoma University· Oklahoma City, OKUniversity of Pennsylvania/Abramson Cancer Center· Philadelphia, PATennessee Oncology· Nashville, TN

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