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

NCT05898399 | Recruiting Phase 1 FDA Drug

• 1 other identifier: ART6043C001
• Study Type: interventional
• Target: 181
• Locations: 2 countries
• Sites: 12

Brief Summary

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

Conditions

Advanced Solid Tumor; Metastatic Solid Tumor

Keywords

Metastatic Cancer; HER2-negative Breast Cancer; Poly (adenosine diphosphate ribose) polymerase (PARP) inhibitor (PARPi); Human epidermal growth factor receptor 2 negative (HER2-ve); Oral anticancer; Sensitivity to Polymerase Theta Inhibitor; BRCA

Outcome Measures

Primary Outcomes (2)

• 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.

  From first dose of study treatment until the end of Cycle 1 (each cycle is 21-days)

• 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.

  Until disease progression (Upto 3.7 years).

Secondary Outcomes (11)

• Part B2: Number of participants with Adverse events

  Screening (≤28 days) Until follow-up visit (90 days after discontinuation)] (up to 3.7 years)

• Best overall response (BOR)

  Screening (≤28 days) Until disease progression/recurrence (Upto 3.7 years)

• Objective Response Rate (ORR)

  Screening (≤28 days) Until disease progression/recurrence (Upto 3.7 years)

• Disease control rate (DCR)

  Screening (≤28 days) Until disease progression (Upto 3.7 years)

• Duration of response (DOR)

  Screening (≤28 days) Until disease progression (Upto 3.7 years)

Study Arms (3)

Part A1 (ART6043 as monotherapy)

EXPERIMENTAL

Patients with advanced or metastatic cancer will receive ART6043 administered in 21-day cycles.

Drug: ART6043

Part A2 (ART6043 in combination with olaparib)

EXPERIMENTAL

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.

Drug: ART6043; Drug: Olaparib

Part B2 (ART6043 in combination with olaparib)

EXPERIMENTAL

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.

Drug: ART6043; Drug: Olaparib

Interventions

ART6043 DRUG

ART6043 will be given orally.

Part A1 (ART6043 as monotherapy); Part A2 (ART6043 in combination with olaparib); Part B2 (ART6043 in combination with olaparib)

Olaparib DRUG

Olaparib will be given orally.

Part A2 (ART6043 in combination with olaparib); Part B2 (ART6043 in combination with olaparib)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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 prior treatment with a PARPi.
• Histologically or cytologically confirmed HER2-ve locally advanced or metastatic carcinoma of the breast.
• Documentation of a deleterious or suspected deleterious gBRCA mutation.
• Previously treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting unless medically contraindicated.
• Prior treatment with a taxane in the neoadjuvant, adjuvant, locally advanced, or metastatic setting unless medically contraindicated.
• Patients must have received no or ≤1 month of prior treatment with a PARPi.

You may not qualify if:

• 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.
• Patients with brain metastases (patients with treated brain metastases could be eligible if follow-up brain imaging after central nervous system-directed therapy shows no evidence of progression).
• Have received a live vaccine within 30 days before the first dose of study treatment.
• Recent major surgery within 4 weeks prior to entry into the study.
• Have a significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 12 weeks prior to enrollment.
• Have a history of allergy or hypersensitivity to study drug components.
• First-line locally advanced and/or metastatic breast cancer with no prior adjuvant chemotherapy.
• Inflammatory breast cancer.

Sponsors & Collaborators

• Artios Pharma Ltd: lead

Study Sites (12)

South Texas Accelerated Research Therapeutics (START) - Midwest

Grand Rapids, Michigan, 49546, United States

ACTIVE NOT RECRUITING

Memorial Sloan-Kettering Cancer Center (MSKCC)

New York, New York, 10065-6800, United States

ACTIVE NOT RECRUITING

Stephenson Cancer Center - Oncology

Oklahoma City, Oklahoma, 73104, United States

ACTIVE NOT RECRUITING

Jefferson University Hospitals - Kimmel Cancer Center

Philadelphia, Pennsylvania, 17107, United States

ACTIVE NOT RECRUITING

SCRI oncology partners

Nashville, Tennessee, 37203, United States

COMPLETED

Mary Crowley Cancer Center - Clinic

Dallas, Texas, 75251, United States

COMPLETED

The University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

ACTIVE NOT RECRUITING

Hospital Universitario Clínico San Cecilio

Granada, Andalusia, 18007, Spain

RECRUITING

Hospital Clínico Universitario de Valladolid

Valladolid, Castille and León, 47003, Spain

RECRUITING

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalonia, 08025, Spain

RECRUITING

Hospital San Pedro de Alcántara

Cáceres, Extremadura, 10003, Spain

RECRUITING

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

olaparib

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Artios Pharma

CONTACT

+44 (0)1223 867 900; info@artios.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: June 12, 2023
• Study Start: June 30, 2023
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (5); US (7)