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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
Study Summary
This trial will study the safety, effectiveness, and how the body processes a new drug with or without other existing treatments.
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.Check my eligibility
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.See study design
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).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Part A: Number of participants with Dose Limiting Toxicities (DLTs)
Part B: Progression free survival (PFS)
Secondary outcome measures
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 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Part B (ART6043 in combination with a PARPi or a PARPi alone)Experimental Treatment2 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 and Talazoparib).
Group II: Part A3 (ART6043 in combination with Talazoparib)Experimental Treatment2 Interventions
Patients with advanced or metastatic cancer and with PARPi as an appropriate treatment option will be given ART6043 in combination with Talazoparib once daily (QD) in 21-day cycles.
Group III: 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 IV: 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
Talazoparib
2021
Completed Phase 2
~2770
Olaparib
2007
Completed Phase 4
~2140
Find a Location
Who is running the clinical trial?
Artios Pharma LtdLead Sponsor
5 Previous Clinical Trials
1,261 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had less than or equal to one month of PARPi treatment.My brain cancer has not worsened after treatment.I have been diagnosed with MDS, AML, or have symptoms suggesting these conditions.My breast cancer is advanced or has spread, and I haven't had chemotherapy before.I have finished any palliative radiotherapy before starting this study.My organs are functioning well.My breast cancer is advanced or has spread and is HER2 negative.I have had 3 or fewer chemotherapy treatments for my advanced cancer.I have a harmful BRCA gene mutation.I have not had major surgery in the last 4 weeks.I have not received a live vaccine in the last 30 days.I am considered a good candidate for PARPi treatment.I have recovered from all side effects of my previous treatments or surgeries.My condition is inflammatory breast cancer.I can take care of myself and perform daily activities.I don't have major stomach or intestine problems affecting medicine absorption.I have a lung condition that causes scarring or inflammation.I have been treated with a taxane unless it was not suitable for me.My advanced cancer has genetic changes affecting DNA repair genes.I stopped all cancer treatments except for palliative radiotherapy at least 21 days ago or 5 half-lives, whichever is longer.I stopped my hormone therapy for cancer 7 days before starting the study medication.I haven't had a severe bleeding episode or a bleeding disorder in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Part A2 (ART6043 in combination with Olaparib)
- Group 2: Part A3 (ART6043 in combination with Talazoparib)
- Group 3: Part B (ART6043 in combination with a PARPi or a PARPi alone)
- Group 4: Part A1 (ART6043 as monotherapy)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What specific goals are this experiment attempting to achieve?
"This clinical trial's primary assessment is to measure the number of participants who experience Dose Limiting Toxicities (DLTs) over a period up to 3.7 years. The secondary evaluations are Progression Free Survival (PFS), Adverse Events, and Disease Control Rate (DCR). PFS will be observed from randomization until progression or death; AE assesses safety and tolerability at Recommended Phase II doses; DCR looks for preliminary efficacy signals with ART6043 as monotherapy or in combination with either olaparib or talazoparib."
Answered by AI
Are there any vacant spots available for this clinical exploration?
"Per records hosted on clinicaltrials.gov, this medical trial is open to enrollment and actively searching for suitable participants. This investigation was first unveiled June 30th 2023 and the last update occurred July 12th of the same year."
Answered by AI
What is the current enrolment size of this research project?
"Affirmative. Per the information posted on clinicaltrials.gov, this research effort is actively seeking participants and was first published on June 30th 2023 with updates occurring as recently as July 12th of the same year. A total of 250 patients need to be enrolled from 2 separate sites for completion."
Answered by AI
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