What side effects are associated with this type of intervention?

Common treatments for metastatic tumors, including chemotherapy, targeted therapy, and immunotherapy, have a range of side effects. Chemotherapy can cause nausea, vomiting, hair loss, and myelosuppression. Targeted therapies, such as tyrosine kinase inhibitors, often lead to hypertension, diarrhea, and skin rashes. Immunotherapies, like checkpoint inhibitors, may result in immune-related adverse events, including pneumonitis, colitis, and endocrinopathies. These side effects vary in severity and frequency depending on the specific treatment regimen.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of metastatic tumors, including tyrosine kinase inhibitors like cabozantinib (approved for medullary thyroid cancer) and immune checkpoint inhibitors such as pembrolizumab and nivolumab (used in various cancers including renal cell carcinoma and head and neck cancer). Combination therapies, such as atezolizumab plus bevacizumab for renal cell carcinoma, have also been approved. These treatments target different pathways involved in tumor growth and immune evasion, providing a multifaceted approach to managing metastatic disease.

What other types of research exist?

Promising alternatives to ART6043 for metastatic tumor patients include: 1) Pembrolizumab plus chemotherapy, as shown in the KEYNOTE-189 trial for non-small-cell lung cancer. 2) Atezolizumab in combination with bevacizumab and chemotherapy, as demonstrated in the IMpower150 trial for non-small-cell lung cancer. 3) Cabozantinib, an oral tyrosine kinase inhibitor, which has shown activity in medullary thyroid cancer. 4) Lutetium-177-PSMA-617, a radioligand therapy for metastatic castration-resistant prostate cancer, as evidenced by the VISION trial. These therapies have demonstrated efficacy and safety in clinical trials and represent novel treatment options for metastatic cancer patients.

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ART6043 for Metastatic Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Artios Pharma Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until disease progression (upto 3.7 years).

Awards & highlights

No Placebo-Only Group

Summary

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 in DNA repair. The treatment aims to exploit the cancer cells' inability to fix their DNA, making it harder for them to survive. Olaparib is used to treat certain cancers by preventing the cancer cells from fixing their DNA, which makes it harder for them to survive.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, common ones from similar therapies include nausea, fatigue, blood cell count changes leading to increased infection risk or bleeding problems; allergic reactions; potential lung issues like pneumonitis; and other drug-specific reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until disease progression (upto 3.7 years).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until disease progression (upto 3.7 years).

This trial's timeline: 3 weeks for screening, Varies for treatment, and until disease progression (upto 3.7 years). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part A: Number of participants with Dose Limiting Toxicities (DLTs)

Part B1: Number of participants with adverse events

Part B2: Progression free survival (PFS)

Secondary study objectives

Area under the plasma concentration-time curve from zero to infinity (AUC0-inf)

Best overall response (BOR)

Cancer antigen 125 levels in pre-dose tumor samples

+12 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Part B2 (ART6043 in combination with a PARPi or a PARPi alone)Experimental Treatment3 Interventions

Patients with g/sBRCA-m, HER2-ve locally advanced or metastatic breast cancer will be randomly assigned to receive ART6043 in combination with a PARPi or a PARPi alone (Olaparib or Niraparib).

Group II: Part B1 (ART6043 in combination with a PARPi)Experimental Treatment3 Interventions

Patients with g/sBRCA-m, HER2-ve locally advanced or metastatic breast cancer will be assigned to receive ART6043 in combination with a PARPi (Olaparib or Niraparib).

Group III: Part A3 (ART6043 in combination with Niraparib)Experimental Treatment2 Interventions

Patients with advanced or metastatic cancer and with PARPi as an appropriate treatment option will be given ART6043 in combination with Niraparib once daily (QD) in 21-day cycles.

Group IV: Part A2 (ART6043 in combination with Olaparib)Experimental Treatment2 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 V: Part A1 (ART6043 as monotherapy)Experimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Olaparib

2007

Completed Phase 4

~2190

Niraparib

2018

Completed Phase 4

~2400

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for metastatic tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but can also affect normal cells, leading to side effects. Targeted therapies, such as tyrosine kinase inhibitors, specifically target molecular pathways essential for tumor growth and survival, thereby minimizing damage to normal cells. Immunotherapy, including immune checkpoint inhibitors, enhances the body's immune response against cancer cells. Understanding these mechanisms is vital for metastatic tumor patients as it helps in selecting the most appropriate treatment, managing side effects, and improving overall outcomes by tailoring therapies to the specific characteristics of their cancer.

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