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

NCT04991480 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2026-01-27

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

ART4215

Participants will receive ART4215 by mouth daily in 21-day cycles.

DRUG

Talazoparib

Talazoparib will be administered at a dose of 1 mg or 0.75 mg by mouth daily in 21-day cycles.

DRUG

Niraparib

Niraparib will be administered at a dose of 200 mg or 300 mg by mouth daily in 21-day cycles.

Sponsors & Collaborators

  • Artios Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Erika Hamilton, MD · Tennessee Oncology

  • Timothy Yap, MBBS, PhD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-13
Primary Completion
2025-12-24
Completion
2025-12-24
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04991480 on ClinicalTrials.gov