ART6043 for Metastatic Cancer

Not currently recruiting at 6 trial locations

Overseen By Artios Pharma

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Artios Pharma Ltd

Must be taking: PARPi

Disqualifiers: Pregnancy, MDS/AML, Brain metastases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ART6043 for individuals with advanced or metastatic cancer. Researchers aim to assess the safety and effectiveness of ART6043, both alone and in combination with another drug, olaparib. The trial includes different groups, such as those with specific types of breast cancer and those who might benefit from PARPi drugs, which target cancer cells. Ideal candidates for this trial have advanced cancer, have discontinued other treatments for at least three weeks, and possess specific genetic markers from previous tests. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop taking all previous chemotherapeutic agents, non-hormonal targeted therapy, or investigational drugs for at least 21 days or 5 half-lives before starting the study. Endocrine and hormonal therapies for cancer must be stopped at least 7 days before the study, unless you are being treated for prostate cancer.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ART6043 is being carefully studied for safety and tolerance in people. Early results suggest that daily use of ART6043 alone does not cause serious problems for most individuals, indicating a lack of severe side effects. However, specific details about any side effects remain unavailable.

Researchers are also examining how ART6043 interacts with another drug, olaparib. Olaparib is already used to treat cancer, providing some knowledge about its safety. The combination of these drugs is still under investigation to ensure their safe use together.

These studies are in the early stages, focusing on ensuring the treatment's safety for patients. The trials aim to determine the right dose and identify any side effects. Researchers closely monitor participants' health and well-being throughout the study. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ART6043 for metastatic cancer because it offers a new approach by combining with olaparib, a PARP inhibitor. Unlike standard treatments like chemotherapy, which broadly attack cancer cells, ART6043 is designed to work more precisely. It's particularly promising as it targets cancer cells with specific genetic mutations, potentially leading to more effective and personalized treatment options. Additionally, ART6043's combination with olaparib might enhance the effectiveness of treatment in patients with BRCA-mutated, HER2-negative breast cancer, offering hope for better outcomes.

What evidence suggests that this trial's treatments could be effective for metastatic cancer?

Research has shown that ART6043 could help treat certain cancers by targeting a specific enzyme essential for cancer cell survival. In this trial, some participants will receive ART6043 as monotherapy, while others will receive it in combination with olaparib. Early results suggest that ART6043, particularly when combined with olaparib, might effectively weaken tumor cells with certain genetic changes. One study indicated that patients with advanced solid tumors benefited from this combination. Olaparib blocks a protein involved in DNA repair and has been effective in slowing cancer growth. Although more research is needed, these early findings are promising for its potential use in advanced cancer. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic solid tumors who've had prior taxane treatment, unless not medically advised. They should have an ECOG performance status of 0-2, adequate organ function, and a life expectancy of at least 12 weeks. It's also for those with specific genetic mutations in DDR genes and who consider PARPi therapy suitable. Pregnant individuals, those with certain gastrointestinal issues, brain metastases (unless treated), allergies to study drugs, MDS/AML or features suggestive of these conditions are excluded.

Inclusion Criteria

I have had less than or equal to one month of PARPi treatment.

Radiologically evaluable and measurable and/or non-measurable disease

I have had 3 or fewer chemotherapy treatments for my advanced cancer.

Exclusion Criteria

Patients who are pregnant

My brain cancer has not worsened after treatment.

I have been diagnosed with MDS, AML, or have symptoms suggesting these conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

≤4 weeks

Dose-escalation

Part A will evaluate ART6043 as monotherapy and in combination with PARPi in patients with advanced or metastatic cancer.

21-day cycles

Cycle 0 Days -2, -1, Cycle 1 Days 1, 8, 15, 16, Cycle 2 Days 1, 8, 15, Cycle 3 Day 1

Dose-expansion

Part B will confirm the safety of ART6043 in combination with PARPi and assess initial effectiveness compared to PARPi alone.

21-day cycles

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days after discontinuation

What Are the Treatments Tested in This Trial?

Interventions

• ART6043

Trial Overview The study tests ART6043 alone or combined with Olaparib or Talazoparib on patients with solid tumors. It aims to assess the safety and how well the body handles these treatments (pharmacokinetics) as well as their initial effectiveness against cancer.

How Is the Trial Designed?

Group I: Part B2 (ART6043 in combination with olaparib) Experimental Treatment 2 Interventions

Patients with g/sBRCA-m, HER2-ve locally advanced or metastatic breast cancer will be randomly assigned to receive ART6043 in combination with olaparib or olaparib alone.

Group II: Part B1 (ART6043 in combination with olaparib) Experimental Treatment 2 Interventions

Patients with g/sBRCA-m, HER2-ve locally advanced or metastatic breast cancer will be assigned to receive ART6043 in combination with olaparib.

Group III: Part A2 (ART6043 in combination with olaparib) Experimental Treatment 2 Interventions

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.

Group IV: Part A1 (ART6043 as monotherapy) Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Artios Pharma Ltd

Lead Sponsor

Trials

6

Recruited

1,600+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05898399

NCT05898399 | Study of ART6043 in Advanced/Metastatic ... This interventional study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ART6043 as monotherapy or in combination with ...

2. clinicaltrials.eu clinicaltrials.eu/trial/study-of-art6043-olaparib-and-niraparib-in-patients-with-advanced-or-metastatic-solid-tumors/

Study of ART6043, Olaparib, and Niraparib in Patients with ... Upon completion, the data collected will contribute to understanding the safety and effectiveness of ART6043 in treating advanced or metastatic solid tumors.

3. withpower.com withpower.com/trial/phase-2-neoplasms-5-2023-a2424

ART6043 for Metastatic Cancer · Info for Participants This trial tests a new cancer drug, ART6043, alone or with other drugs (Olaparib and Niraparib) in patients with advanced cancers that have genetic defects ...

4. nature.com nature.com/articles/s41417-024-00815-2

Polθ: synthetic lethal partner in HR-deficient tumors The NCT05898399 is a Phase I/II trial enrolling up to 250 patients with advanced or metastatic cancer. It explores the combination of ART6043 ...

5. lynparza.com lynparza.com/breast-cancer/results/metastatic-breast-cancer.html

LYNPARZA: Prevented disease progression or death vs chemo LYNPARZA lowered the risk of cancer growing or spreading, or death by 42% compared with certain chemotherapies. 52% of people who took LYNPARZA and 23% of ...

6. artios.com artios.com/pipeline/

Pipeline Overview ART6043 is being evaluated in an ongoing Phase 1/2a study as monotherapy in patients with advanced or metastatic solid tumors that have a loss of function of ...

7. trial.medpath.com trial.medpath.com/news/4704eb4c2c7c95b9/artios-reports-first-clinical-data-for-dna-polymerase-theta-inhibitor-art6043-at-esmo-2025

Artios Reports First Clinical Data for DNA Polymerase Theta ... The Phase 1/2a study enrolled 61 patients with advanced solid tumors, demonstrating that ART6043 can be dosed orally once daily with no drug- ...

8. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-08450

Study of ART6043 in Advanced/Metastatic Solid Tumors ... This interventional study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ART6043 as monotherapy or in combination ...