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New cancer drug ART6043 enters human trials for advanced tumors

NCT ID NCT05898399

Disease control Sponsor: Artios Pharma Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 16, 2026 · Updated 3 times

Summary

This study tests a new oral drug called ART6043, alone or with another drug (olaparib), in 181 people with advanced or metastatic solid tumors. The goal is to check safety, how the body processes the drug, and whether it can slow tumor growth. It is an early-stage trial, so the main focus is on finding the right dose and seeing if it is safe enough to study further.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ART6043 (a DNA polymerase theta inhibitor) and olaparib
What this could lead to
If successful, this could provide a new treatment option for people with advanced or metastatic solid tumors, potentially slowing disease progression.
What could go wrong
This is an early-phase trial (Phase 1/2a) with a small number of participants, so the drug may not prove effective or safe. Side effects are possible, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 181 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * 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. Inclusion Criteria specific to Part A1 (ART6043 as Monotherapy) • 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. Inclusion criteria specific to Part A2 (ART6043 in combination with olaparib) * 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. Inclusion criteria specific to Part B (ART6043 in combination with olaparib or olaparib alone) * 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. * Patients must have received no or ≤1 month of prior treatment with a PARPi. Exclusion Criteria: * 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. * 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. Exclusion criteria specific to Part B • Inflammatory breast cancer.

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Conditions

The condition(s) this trial relates to.

Her2-receptor negative breast cancer metastatic malignant neoplasm neoplasm Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor Metastatic solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    11 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Hospital Clinico San Carlos

    RECRUITING

    San Carlos, Madrid, 28040, Spain

  • Hospital Clinico Universitario Lozano Blesa

    RECRUITING

    Zaragoza, 50009, Spain

  • Hospital Clinico Universitario Virgen de la Arrixaca

    RECRUITING

    Murcia, 30120, Spain

  • Hospital Clinico Universitario de Valencia

    RECRUITING

    Valencia, 46010, Spain

  • Hospital Clínico Universitario de Valladolid

    RECRUITING

    Valladolid, Castille and León, 47003, Spain

  • Hospital San Pedro de Alcántara

    RECRUITING

    Cáceres, Extremadura, 10003, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario Clínico San Cecilio

    RECRUITING

    Granada, Andalusia, 18007, Spain

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, 41001, Spain

  • Hospital Universitario de Jerez de la Frontera

    RECRUITING

    Cadiz, 11407, Spain

  • Hospital de la Santa Creu i Sant Pau

    RECRUITING

    Barcelona, Catalonia, 08025, Spain

  • Jefferson University Hospitals - Kimmel Cancer Center

    ACTIVE_NOT_RECRUITING

    Philadelphia, Pennsylvania, 17107, United States

  • Mary Crowley Cancer Center - Clinic

    COMPLETED

    Dallas, Texas, 75251, United States

  • Memorial Sloan-Kettering Cancer Center (MSKCC)

    ACTIVE_NOT_RECRUITING

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

  • SCRI oncology partners

    COMPLETED

    Nashville, Tennessee, 37203, United States

  • South Texas Accelerated Research Therapeutics (START) - Midwest

    ACTIVE_NOT_RECRUITING

    Grand Rapids, Michigan, 49546, United States

  • Stephenson Cancer Center - Oncology

    ACTIVE_NOT_RECRUITING

    Oklahoma City, Oklahoma, 73104, United States

  • The University of Texas - MD Anderson Cancer Center

    ACTIVE_NOT_RECRUITING

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.